Trial Outcomes & Findings for Decision Support for Intraoperative Low Blood Pressure (NCT NCT02726620)
NCT ID: NCT02726620
Last Updated: 2019-05-16
Results Overview
Postoperative Acute Kidney Injury (AKI), Stage I or higher according to the KDIGO criteria (Kidney Disease: Improving Global Outcomes). The staging will be based on serum creatinine values, as documentation of urine output is probably not sufficiently accurate. This will be the primary outcome for the Vanderbilt University Medical Center. The creatinine measurements are part of routine clinical care. Therefore, absence of creatinine postoperative measurements are considered to be 'no suspicion of kidney injury'. KDIGO defines AKI as any of the following: Increase in serum creatinine by 0.3mg/dL or more within 48 hours or Increase in serum creatinine to 1.5 times baseline or more within the last 7 days or Urine output less than 0.5 mL/kg/h for 6 hours. Stage 1 is 1.5-9x baseline or \>0.3 increase; Stage 2 is 2-2.9x baseline; Stage 3 is 3x baseline, or increase to \> 4, or initiation of renal replacement therapy.
COMPLETED
NA
22435 participants
Within 7 days after surgery
2019-05-16
Participant Flow
Participant milestones
| Measure |
Usual Care Group
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Historic Cohort - Three Years
STARTED
|
17463
|
0
|
|
Historic Cohort - Three Years
MAP < 65 mmHg: Primary Analysis
|
15624
|
0
|
|
Historic Cohort - Three Years
COMPLETED
|
17463
|
0
|
|
Historic Cohort - Three Years
NOT COMPLETED
|
0
|
0
|
|
Month 1: Attending Randomization
STARTED
|
0
|
485
|
|
Month 1: Attending Randomization
MAP < 65 mmHg: Primary Analysis
|
0
|
432
|
|
Month 1: Attending Randomization
Correct IOH Notifications
|
0
|
313
|
|
Month 1: Attending Randomization
COMPLETED
|
0
|
485
|
|
Month 1: Attending Randomization
NOT COMPLETED
|
0
|
0
|
|
Months 2-3: In-room Providers Randomized
STARTED
|
0
|
1253
|
|
Months 2-3: In-room Providers Randomized
MAP < 65 mmHg: Primary Analysis
|
0
|
1103
|
|
Months 2-3: In-room Providers Randomized
Correct IOH Notifications
|
0
|
825
|
|
Months 2-3: In-room Providers Randomized
COMPLETED
|
0
|
1253
|
|
Months 2-3: In-room Providers Randomized
NOT COMPLETED
|
0
|
0
|
|
Through End of Study: All Interventions
STARTED
|
0
|
3234
|
|
Through End of Study: All Interventions
MAP < 65 mmHg: Primary Analysis
|
0
|
2793
|
|
Through End of Study: All Interventions
Correct IOH Notifications
|
0
|
2072
|
|
Through End of Study: All Interventions
COMPLETED
|
0
|
3234
|
|
Through End of Study: All Interventions
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Incomplete patient demographics section resulted in a row population difference from the Overall.
Baseline characteristics by cohort
| Measure |
Usual Care Group
n=17463 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4972 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
Total
n=22435 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=17463 Participants
|
68 years
n=4972 Participants
|
68 years
n=22435 Participants
|
|
Sex: Female, Male
Female
|
7731 Participants
n=17438 Participants • Incomplete patient demographics section resulted in a row population difference from the Overall.
|
2141 Participants
n=4963 Participants • Incomplete patient demographics section resulted in a row population difference from the Overall.
|
9872 Participants
n=22401 Participants • Incomplete patient demographics section resulted in a row population difference from the Overall.
|
|
Sex: Female, Male
Male
|
9707 Participants
n=17438 Participants • Incomplete patient demographics section resulted in a row population difference from the Overall.
|
2822 Participants
n=4963 Participants • Incomplete patient demographics section resulted in a row population difference from the Overall.
|
12529 Participants
n=22401 Participants • Incomplete patient demographics section resulted in a row population difference from the Overall.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
18 Participants
n=17463 Participants
|
4 Participants
n=4972 Participants
|
22 Participants
n=22435 Participants
|
|
Race (NIH/OMB)
Asian
|
113 Participants
n=17463 Participants
|
36 Participants
n=4972 Participants
|
149 Participants
n=22435 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=17463 Participants
|
0 Participants
n=4972 Participants
|
0 Participants
n=22435 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1111 Participants
n=17463 Participants
|
380 Participants
n=4972 Participants
|
1491 Participants
n=22435 Participants
|
|
Race (NIH/OMB)
White
|
15571 Participants
n=17463 Participants
|
4348 Participants
n=4972 Participants
|
19919 Participants
n=22435 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=17463 Participants
|
0 Participants
n=4972 Participants
|
0 Participants
n=22435 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
650 Participants
n=17463 Participants
|
204 Participants
n=4972 Participants
|
854 Participants
n=22435 Participants
|
|
Region of Enrollment
United States
|
17463 participants
n=17463 Participants
|
4972 participants
n=4972 Participants
|
22435 participants
n=22435 Participants
|
|
Body Mass Index
|
28 kg/m^2
n=17306 Participants • Incorrect demographics data resulted in row population differences from overall.
|
28 kg/m^2
n=4930 Participants • Incorrect demographics data resulted in row population differences from overall.
|
28 kg/m^2
n=22236 Participants • Incorrect demographics data resulted in row population differences from overall.
|
|
ASA Class
ASA Class 1
|
74 Participants
n=17463 Participants
|
16 Participants
n=4972 Participants
|
90 Participants
n=22435 Participants
|
|
ASA Class
ASA Class 2
|
3109 Participants
n=17463 Participants
|
765 Participants
n=4972 Participants
|
3874 Participants
n=22435 Participants
|
|
ASA Class
ASA Class 3
|
12344 Participants
n=17463 Participants
|
3578 Participants
n=4972 Participants
|
15922 Participants
n=22435 Participants
|
|
ASA Class
ASA Class 4
|
1885 Participants
n=17463 Participants
|
585 Participants
n=4972 Participants
|
2470 Participants
n=22435 Participants
|
|
ASA Class
ASA Class 5
|
51 Participants
n=17463 Participants
|
28 Participants
n=4972 Participants
|
79 Participants
n=22435 Participants
|
|
Hypertension
|
11403 Participants
n=15718 Participants • No preoperative data on comorbidities was available in a structured form, resulting in missings.
|
3348 Participants
n=4500 Participants • No preoperative data on comorbidities was available in a structured form, resulting in missings.
|
14751 Participants
n=20218 Participants • No preoperative data on comorbidities was available in a structured form, resulting in missings.
|
|
Cardiac disease
|
4843 Participants
n=15718 Participants • No preoperative data on comorbidities was available in a structured form, resulting in missings.
|
1489 Participants
n=4500 Participants • No preoperative data on comorbidities was available in a structured form, resulting in missings.
|
6332 Participants
n=20218 Participants • No preoperative data on comorbidities was available in a structured form, resulting in missings.
|
|
Renal Disease
|
1432 Participants
n=15718 Participants • No preoperative data on comorbidities was available in a structured form, resulting in missings.
|
511 Participants
n=4500 Participants • No preoperative data on comorbidities was available in a structured form, resulting in missings.
|
1943 Participants
n=20218 Participants • No preoperative data on comorbidities was available in a structured form, resulting in missings.
|
|
Peripheral vascular disease
|
1947 Participants
n=15718 Participants • No preoperative data on comorbidities was available in a structured form, resulting in missings.
|
596 Participants
n=4500 Participants • No preoperative data on comorbidities was available in a structured form, resulting in missings.
|
2543 Participants
n=20218 Participants • No preoperative data on comorbidities was available in a structured form, resulting in missings.
|
|
Diabetes Mellitus
|
4456 Participants
n=15718 Participants • No preoperative data on comorbidities was available in a structured form, resulting in missings.
|
1296 Participants
n=4500 Participants • No preoperative data on comorbidities was available in a structured form, resulting in missings.
|
5752 Participants
n=20218 Participants • No preoperative data on comorbidities was available in a structured form, resulting in missings.
|
|
Type of anesthesia
General anesthesia
|
17051 Participants
n=17463 Participants
|
4750 Participants
n=4972 Participants
|
21801 Participants
n=22435 Participants
|
|
Type of anesthesia
Central neuraxial anesthesia
|
412 Participants
n=17463 Participants
|
222 Participants
n=4972 Participants
|
634 Participants
n=22435 Participants
|
|
Procedure urgency
Elective surgery
|
16452 Participants
n=17463 Participants
|
4631 Participants
n=4972 Participants
|
21083 Participants
n=22435 Participants
|
|
Procedure urgency
Emergency surgery
|
1011 Participants
n=17463 Participants
|
341 Participants
n=4972 Participants
|
1352 Participants
n=22435 Participants
|
|
Procedure duration
|
201 minutes
n=17463 Participants
|
196 minutes
n=4972 Participants
|
200 minutes
n=22435 Participants
|
|
Surgical service
ENT
|
1891 Participants
n=17463 Participants
|
528 Participants
n=4972 Participants
|
2419 Participants
n=22435 Participants
|
|
Surgical service
Gynecology
|
113 Participants
n=17463 Participants
|
30 Participants
n=4972 Participants
|
143 Participants
n=22435 Participants
|
|
Surgical service
General surgery
|
3638 Participants
n=17463 Participants
|
1001 Participants
n=4972 Participants
|
4639 Participants
n=22435 Participants
|
|
Surgical service
Neurosurgery
|
2138 Participants
n=17463 Participants
|
622 Participants
n=4972 Participants
|
2760 Participants
n=22435 Participants
|
|
Surgical service
Orthopedic surgery
|
4283 Participants
n=17463 Participants
|
1222 Participants
n=4972 Participants
|
5505 Participants
n=22435 Participants
|
|
Surgical service
Plastic surgery
|
776 Participants
n=17463 Participants
|
195 Participants
n=4972 Participants
|
971 Participants
n=22435 Participants
|
|
Surgical service
Thoracic surgery
|
1056 Participants
n=17463 Participants
|
310 Participants
n=4972 Participants
|
1366 Participants
n=22435 Participants
|
|
Surgical service
Urology
|
2648 Participants
n=17463 Participants
|
778 Participants
n=4972 Participants
|
3426 Participants
n=22435 Participants
|
|
Surgical service
Vascular surgery
|
920 Participants
n=17463 Participants
|
286 Participants
n=4972 Participants
|
1206 Participants
n=22435 Participants
|
|
AKI risk based on IOH depth and duration
AKI risk: none
|
3684 Participants
n=17463 Participants
|
1174 Participants
n=4972 Participants
|
4858 Participants
n=22435 Participants
|
|
AKI risk based on IOH depth and duration
AKI risk: mild
|
6622 Participants
n=17463 Participants
|
1985 Participants
n=4972 Participants
|
8607 Participants
n=22435 Participants
|
|
AKI risk based on IOH depth and duration
AKI risk: moderate
|
4290 Participants
n=17463 Participants
|
1136 Participants
n=4972 Participants
|
5426 Participants
n=22435 Participants
|
|
AKI risk based on IOH depth and duration
AKI risk: high
|
2867 Participants
n=17463 Participants
|
677 Participants
n=4972 Participants
|
3544 Participants
n=22435 Participants
|
PRIMARY outcome
Timeframe: Within 7 days after surgeryPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Postoperative Acute Kidney Injury (AKI), Stage I or higher according to the KDIGO criteria (Kidney Disease: Improving Global Outcomes). The staging will be based on serum creatinine values, as documentation of urine output is probably not sufficiently accurate. This will be the primary outcome for the Vanderbilt University Medical Center. The creatinine measurements are part of routine clinical care. Therefore, absence of creatinine postoperative measurements are considered to be 'no suspicion of kidney injury'. KDIGO defines AKI as any of the following: Increase in serum creatinine by 0.3mg/dL or more within 48 hours or Increase in serum creatinine to 1.5 times baseline or more within the last 7 days or Urine output less than 0.5 mL/kg/h for 6 hours. Stage 1 is 1.5-9x baseline or \>0.3 increase; Stage 2 is 2-2.9x baseline; Stage 3 is 3x baseline, or increase to \> 4, or initiation of renal replacement therapy.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Postoperative Acute Kidney Injury
AKI stage I or greater
|
1333 Participants
|
372 Participants
|
|
Postoperative Acute Kidney Injury
No AKI - Confirmed by measurement
|
9670 Participants
|
2785 Participants
|
|
Postoperative Acute Kidney Injury
No postoperative creatinine measurement
|
4621 Participants
|
1171 Participants
|
SECONDARY outcome
Timeframe: 30 days after surgeryPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). For a large group of patients no mortality information was available.
Vanderbilt University Medical Center: combination of in-hospital mortality and 'alive-index' (which checks for visits to the hospital in the electronic healthcare record as indication of being alive at 30 days)
Outcome measures
| Measure |
Usual Care Group
n=4667 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=1285 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
30-day Mortality
|
511 Participants
|
143 Participants
|
SECONDARY outcome
Timeframe: All postoperative days during a single hospital admission, expected median of 5 daysPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Hospital mortality rate during a single hospital admission after the surgery
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
In-hospital Mortality
|
487 Participants
|
137 Participants
|
SECONDARY outcome
Timeframe: Within 7 days after surgeryPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Postoperative Acute Kidney Injury (AKI), Stage II or higher according to the KDIGO criteria (Kidney Disease: Improving Global Outcomes). The staging will be based on serum creatinine values, as documentation of urine output is probably not sufficiently accurate. The creatinine measurements are part of routine clinical care. Therefore, absence of creatinine postoperative measurements are considered to be 'no suspicion of kidney injury'. KDIGO defines AKI as any of the following: Increase in serum creatinine by 0.3mg/dL or more within 48 hours or Increase in serum creatinine to 1.5 times baseline or more within the last 7 days or Urine output less than 0.5 mL/kg/h for 6 hours. Stage 1 is 1.5-9x baseline or \>0.3 increase; Stage 2 is 2-2.9x baseline; Stage 3 is 3x baseline, or increase to \> 4, or initiation of renal replacement therapy.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Postoperative Acute Kidney Injury Stage 2
No stage II or greater - Confirmed by measurement
|
11002 Participants
|
3157 Participants
|
|
Postoperative Acute Kidney Injury Stage 2
AKI stage II or greater
|
1 Participants
|
0 Participants
|
|
Postoperative Acute Kidney Injury Stage 2
No postoperative creatinine measurement
|
4621 Participants
|
1171 Participants
|
SECONDARY outcome
Timeframe: Within 7 days after surgeryPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). Patients with no routine postoperative creatinine measurements are excluded from the analysis.
Absolute values for serum creatinine before and after surgery will be compared. When multiple postoperative creatinine measurements are made, the maximum difference is reported.
Outcome measures
| Measure |
Usual Care Group
n=11003 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=3157 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Postoperative Rise in Creatinine Levels
|
0.00 mg/dL
Interval -0.1 to 0.13
|
0.00 mg/dL
Interval -0.09 to 0.14
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Incidence of a mean arterial pressure (MAP) \< 60 mmHg during anesthesia for 1 minute or more.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Incidence of a MAP < 60 mmHg
|
13779 Participants
|
3798 Participants
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Incidence of a mean arterial pressure (MAP) \< 55 mmHg during anesthesia for 1 minute or more.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Incidence of a MAP < 55 mmHg
|
10991 Participants
|
3045 Participants
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Incidence of a mean arterial pressure (MAP) \< 50 mmHg during anesthesia for 1 minute or more.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Incidence of a MAP < 50 mmHg
|
7781 Participants
|
2196 Participants
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Incidence of a mean arterial pressure (MAP) \< 60 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Incidence of a MAP < 60 mmHg for > 10 Minutes
|
6989 Participants
|
1723 Participants
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Incidence of a mean arterial pressure (MAP) \< 55 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Incidence of a MAP < 55 mmHg for > 10 Minutes
|
3181 Participants
|
759 Participants
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Incidence of a mean arterial pressure (MAP) \< 50 mmHg for a cumulative duration of all hypotensive episodes of more than 10 minutes during the anesthetic phase of the procedure.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Incidence of a MAP < 50 mmHg for > 10 Minutes
|
1159 Participants
|
326 Participants
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Incidence of a mean arterial pressure (MAP) \< 60 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Incidence of a MAP < 60 mmHg for > 20 Minutes
|
3632 Participants
|
792 Participants
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Incidence of a mean arterial pressure (MAP) \< 55 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Incidence of a MAP < 55 mmHg for > 20 Minutes
|
1223 Participants
|
284 Participants
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Incidence of a mean arterial pressure (MAP) \< 50 mmHg for a cumulative duration of all hypotensive episodes of more than 20 minutes during the anesthetic phase of the procedure.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Incidence of a MAP < 50 mmHg for > 20 Minutes
|
304 Participants
|
85 Participants
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Depth and Duration of Intraoperative Hypotension - Threshold MAP 75 mmHg
|
485 mmHg*minute
Interval 243.0 to 915.0
|
417 mmHg*minute
Interval 206.0 to 764.0
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Depth and Duration of Intraoperative Hypotension - Threshold MAP 70 mmHg
|
273 mmHg*minute
Interval 126.0 to 543.0
|
235 mmHg*minute
Interval 109.0 to 451.0
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Depth and Duration of Intraoperative Hypotension - Threshold MAP 65 mmHg
|
96 mmHg*minute
Interval 34.0 to 225.0
|
86 mmHg*minute
Interval 30.0 to 193.0
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Depth and Duration of Intraoperative Hypotension - Threshold MAP 60 mmHg
|
57 mmHg*minute
Interval 21.0 to 131.0
|
52 mmHg*minute
Interval 20.0 to 117.0
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Depth and Duration of Intraoperative Hypotension - Threshold MAP 55 mmHg
|
23 mmHg*minute
Interval 5.0 to 59.0
|
23 mmHg*minute
Interval 5.0 to 62.0
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Depth and duration of intraoperative hypotension will be modeled by calculating areas under the threshold for mean arterial pressures (MAPs). Thresholds will vary from 75 mmHg to 50 mmHg in 5 mmHg decrements. Together these variables represent the depth and duration of intraoperative hypotension. To optimize goodness of fit of these variables, the decremental steps may be increased to 10 mmHg and more restrictive lowest and highest thresholds may be chosen for the statistical analysis.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Depth and Duration of Intraoperative Hypotension - Threshold MAP 50 mmHg
|
19 mmHg*minute
Interval 7.0 to 43.0
|
19 mmHg*minute
Interval 8.0 to 47.0
|
SECONDARY outcome
Timeframe: During the surgical procedure: an expected average of 2 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
The estimated blood loss in mL during the surgical procedure
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Estimated Intraoperative Blood Loss
|
100 mL
Interval 25.0 to 250.0
|
75 mL
Interval 20.0 to 200.0
|
SECONDARY outcome
Timeframe: A specific time frame on the day of surgery: from the start of admission to the PACU to discharge from the PACU, an expected average of 4 hoursPopulation: Only patients with a postoperative stay at the postanesthesia care unit (PACU). Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
The time from arriving at the postanesthesia care unit (PACU) until the time the patient is considered ready for discharge (in minutes).
Outcome measures
| Measure |
Usual Care Group
n=13082 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=3580 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Time to Discharge Readiness at the Postanesthesia Care Unit (PACU)
|
67 minutes
Interval 46.0 to 101.0
|
60 minutes
Interval 42.0 to 89.25
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: All patients with any MAP \< 65 mmHg and a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed.
Average concentrations of propofol infusion rates during MAP \< 65 mmHg episodes
Outcome measures
| Measure |
Usual Care Group
n=14333 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=3926 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg
|
60.10 mcg/kg/min (propofol)
Interval 35.0 to 100.0
|
48.59 mcg/kg/min (propofol)
Interval 28.55 to 83.88
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: All patients with any MAP \< 60 mmHg and either a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed.
Average concentrations of propofol infusion rates during MAP \< 60 mmHg episodes
Outcome measures
| Measure |
Usual Care Group
n=11621 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=3145 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg
|
61.07 mcg/kg/min (propofol)
Interval 37.39 to 100.0
|
50.00 mcg/kg/min (propofol)
Interval 27.65 to 81.5
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: All patients with any MAP \< 55 mmHg and either a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed.
Average concentrations of propofol infusion rates during MAP \< 55 mmHg episodes
Outcome measures
| Measure |
Usual Care Group
n=8254 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=2196 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg
|
63.95 mcg/kg/min (propofol)
Interval 37.5 to 100.0
|
50.00 mcg/kg/min (propofol)
Interval 29.12 to 83.33
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: All patients with any MAP \< 50 mmHg and a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed.
Average concentrations of propofol infusion rates during MAP \< 50 mmHg episodes
Outcome measures
| Measure |
Usual Care Group
n=5135 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=1413 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Intravenous Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg
|
65.00 mcg/kg/min (propofol)
Interval 40.0 to 100.0
|
50.00 mcg/kg/min (propofol)
Interval 30.0 to 82.71
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). In addition, only patients that actually received any ephedrine are analyzed.
Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in \<1% of cases are not reported, as the average dosages would be meaningless.
Outcome measures
| Measure |
Usual Care Group
n=9310 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=2718 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Average Use of Cardiovascular Drugs: Ephedrine
|
20 mg
Interval 10.0 to 25.0
|
15 mg
Interval 10.0 to 25.0
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). In addition, only patients that actually received any phenylephrine are analyzed.
Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in \<1% of cases are not reported, as the average dosage would be meaningless.
Outcome measures
| Measure |
Usual Care Group
n=12211 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=3685 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Average Use of Cardiovascular Drugs: Phenylephrine
|
0.90 mg
Interval 0.3 to 3.69
|
1.30 mg
Interval 0.4 to 5.03
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). In addition, only patients that actually received any glycopyrrolate are analyzed.
Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in \<1% of cases are not reported, as the average dosage would be meaningless.
Outcome measures
| Measure |
Usual Care Group
n=11093 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=1257 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Average Use of Cardiovascular Drugs: Glycopyrrolate
|
0.40 mg
Interval 0.4 to 0.6
|
0.40 mg
Interval 0.2 to 0.4
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). In addition, only patients that actually received any epinephrine are analyzed.
Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in \<1% of cases are not reported, as the average dosage would be meaningless.
Outcome measures
| Measure |
Usual Care Group
n=1215 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=409 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Average Use of Cardiovascular Drugs: Epinephrine
|
1.00 mg
Interval 0.5 to 2.0
|
0.70 mg
Interval 0.5 to 2.0
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section). In addition, only patients that actually received any norepinephrine are analyzed.
Cardiovascular drugs as defined under interventions. Average use for each drug will be calculated. Cardiovascular drugs that were given in \<1% of cases are not reported, as the average dosage would be meaningless.
Outcome measures
| Measure |
Usual Care Group
n=762 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=233 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Average Use of Cardiovascular Drugs: Norepinephrine
|
0.62 mg
Interval 0.27 to 1.35
|
0.70 mg
Interval 0.33 to 1.56
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: All patients with any MAP \< 65 mmHg and an administration event of a cardiovascular drugs within 5 minutes before the start of the hypotensive episode (the first value below 65 mmHg) and 15 minutes after the start of the episode.
Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 60 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP.
Outcome measures
| Measure |
Usual Care Group
n=13932 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=3975 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Timing of Cardiovascular Drugs for MAP < 65 mmHg
|
2 minutes
Interval 0.4 to 4.0
|
1.14 minutes
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: All patients with any MAP \< 60 mmHg and an administration event of a cardiovascular drugs within 5 minutes before the start of the hypotensive episode (the first value below 60 mmHg) and 15 minutes after the start of the episode.
Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 60 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP.
Outcome measures
| Measure |
Usual Care Group
n=12292 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=3458 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Timing of Cardiovascular Drugs for MAP < 60 mmHg
|
0.8 minutes
Interval -0.37 to 2.5
|
1.5 minutes
Interval 0.0 to 3.5
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: All patients with any MAP \< 55 mmHg and an administration event of a cardiovascular drugs within 5 minutes before the start of the hypotensive episode (the first value below 55 mmHg) and 15 minutes after the start of the episode.
Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 55 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP.
Outcome measures
| Measure |
Usual Care Group
n=9706 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=2752 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Timing of Cardiovascular Drugs for MAP < 55 mmHg
|
1 minutes
Interval -0.333 to 3.0
|
0.5 minutes
Interval -0.75 to 2.33
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: All patients with any MAP \< 50 mmHg and an administration event of a cardiovascular drugs within 5 minutes before the start of the hypotensive episode (the first value below 50 mmHg) and 15 minutes after the start of the episode.
Cardiovascular drugs as defined under interventions. Time of first administration of cardiovascular drug relative to the time at which the mean arterial pressure (MAP) drops below 50 mmHg. Per patient the average time to first administration of all hypotensive episodes was calculated. That average time is used as the outcome variable. A negative value indicates that administration occurred before the drop in MAP.
Outcome measures
| Measure |
Usual Care Group
n=6789 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=1989 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Timing of Cardiovascular Drugs for MAP < 50 mmHg
|
1 minutes
Interval -0.833 to 3.0
|
0 minutes
Interval -1.0 to 2.17
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Total amount (mL) of intravenous fluids (as defined under interventions) administered during the surgical procedure.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Intraoperative Administration of Intravenous Fluids
|
1500.00 mL
Interval 1000.0 to 2300.0
|
1400.00 mL
Interval 1000.0 to 2000.0
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: All patients with any MAP \< 65 mmHg and a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed.
Average concentrations of inhalational anesthesia during MAP \< 65 mmHg episodes
Outcome measures
| Measure |
Usual Care Group
n=14333 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=3926 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg
Sevoflurane (EndTidal %)
|
1.35 EndTidal% (other)
Interval 1.03 to 1.6
|
1.27 EndTidal% (other)
Interval 0.98 to 1.55
|
|
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg
Isoflurane (EndTidal %)
|
0.68 EndTidal% (other)
Interval 0.56 to 0.8
|
0.68 EndTidal% (other)
Interval 0.56 to 0.8
|
|
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 65 mmHg
Desflurane (EndTidal %)
|
4.10 EndTidal% (other)
Interval 3.31 to 4.64
|
2.31 EndTidal% (other)
Interval 1.15 to 3.46
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: All patients with any MAP \< 60 mmHg and either a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed.
Average concentrations of inhalational anesthesia during MAP \< 60 mmHg episodes
Outcome measures
| Measure |
Usual Care Group
n=11621 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=3145 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg
Sevoflurane (EndTidal %)
|
1.35 EndTidal% (other)
Interval 1.02 to 1.62
|
1.25 EndTidal% (other)
Interval 0.95 to 1.57
|
|
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg
Isoflurane (EndTidal %)
|
0.68 EndTidal% (other)
Interval 0.55 to 0.8
|
0.67 EndTidal% (other)
Interval 0.55 to 0.8
|
|
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 60 mmHg
Desflurane (EndTidal %)
|
4.36 EndTidal% (other)
Interval 3.4 to 4.8
|
2.33 EndTidal% (other)
Interval 1.116 to 3.49
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: All patients with any MAP \< 55 mmHg and either a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed.
Average concentrations of inhalational anesthesia during MAP \< 55 mmHg episodes
Outcome measures
| Measure |
Usual Care Group
n=8254 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=2196 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg
Sevoflurane (EndTidal %)
|
1.34 EndTidal% (other)
Interval 1.0 to 1.62
|
1.25 EndTidal% (other)
Interval 0.94 to 1.55
|
|
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg
Isoflurane (EndTidal %)
|
0.68 EndTidal% (other)
Interval 0.52 to 0.82
|
0.67 EndTidal% (other)
Interval 0.52 to 0.8
|
|
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 55 mmHg
Desflurane (EndTidal %)
|
4.60 EndTidal% (other)
Interval 3.49 to 4.88
|
4.65 EndTidal% (other)
Interval 4.65 to 4.65
|
SECONDARY outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: All patients with any MAP \< 50 mmHg and a continuous administration of one of the following anesthetics: propofol, sevoflurane, isoflurane, desflurane. On occasion, the anesthesiologist may switch between anesthetic drugs. The numbers analyzed in one or more rows thus does not match the overall number analyzed.
Average concentrations of inhalational anesthesia during MAP \< 50 mmHg episodes
Outcome measures
| Measure |
Usual Care Group
n=5135 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=1413 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg
Sevoflurane (EndTidal %)
|
1.32 EndTidal% (other)
Interval 1.0 to 1.65
|
1.23 EndTidal% (other)
Interval 0.89 to 1.57
|
|
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg
Isoflurane (EndTidal %)
|
0.65 EndTidal% (other)
Interval 0.5 to 0.82
|
0.65 EndTidal% (other)
Interval 0.5 to 0.8
|
|
Inhaled Anesthetic Drug Use During Intraoperative Hypotension: MAP < 50 mmHg
Desflurane (EndTidal %)
|
4.28 EndTidal% (other)
Interval 3.61 to 4.78
|
4.70 EndTidal% (other)
Interval 4.7 to 4.7
|
POST_HOC outcome
Timeframe: Within 7 days after surgeryPopulation: Post-Hoc analysis: all patients, not only those with any MAP \< 65 mmHg.
Postoperative Acute Kidney Injury (AKI), Stage I or higher according to the KDIGO criteria (Kidney Disease: Improving Global Outcomes). The staging will be based on serum creatinine values, as documentation of urine output is probably not sufficiently accurate. This will be the primary outcome for the Vanderbilt University Medical Center. The creatinine measurements are part of routine clinical care. Therefore, absence of creatinine postoperative measurements are considered to be 'no suspicion of kidney injury'. KDIGO defines AKI as any of the following: Increase in serum creatinine by 0.3mg/dL or more within 48 hours or Increase in serum creatinine to 1.5 times baseline or more within the last 7 days or Urine output less than 0.5 mL/kg/h for 6 hours. Stage 1 is 1.5-9x baseline or \>0.3 increase; Stage 2 is 2-2.9x baseline; Stage 3 is 3x baseline, or increase to \> 4, or initiation of renal replacement therapy.
Outcome measures
| Measure |
Usual Care Group
n=17463 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4972 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Postoperative Acute Kidney Injury
AKI stage I or greater
|
1477 Participants
|
435 Participants
|
|
Postoperative Acute Kidney Injury
No AKI - Confirmed by measurement
|
10690 Participants
|
3166 Participants
|
|
Postoperative Acute Kidney Injury
No postoperative creatinine measurement
|
5296 Participants
|
1371 Participants
|
POST_HOC outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in \<1% of cases are not reported.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Usage Frequency of Cardiovascular Drugs: Ephedrine
|
9310 Participants
|
2718 Participants
|
POST_HOC outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in \<1% of cases are not reported.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Usage Frequency of Cardiovascular Drugs: Phenylephrine
|
12211 Participants
|
3685 Participants
|
POST_HOC outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in \<1% of cases are not reported.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Usage Frequency of Cardiovascular Drugs: Glycopyrrolate
|
11093 Participants
|
1257 Participants
|
POST_HOC outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in \<1% of cases are not reported.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Usage Frequency of Cardiovascular Drugs: Ephinephrine
|
1215 Participants
|
409 Participants
|
POST_HOC outcome
Timeframe: During the anesthetic phase of the surgical procedure: an expected average of 2.5 hoursPopulation: Per study protocol only patients with any MAP \< 65 mmHg will be included in the primary analysis (See also 'Participant Flow' section).
Cardiovascular drugs as defined under interventions. Frequency of patients receiving the drug. Cardiovascular drugs that were given in \<1% of cases are not reported.
Outcome measures
| Measure |
Usual Care Group
n=15624 Participants
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4328 Participants
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Usage Frequency of Cardiovascular Drugs: Norepinephrine
|
762 Participants
|
233 Participants
|
Adverse Events
Usual Care Group
Hypotension Decision Support
Serious adverse events
| Measure |
Usual Care Group
n=17463 participants at risk
The 'before' period - or historic control group - during which no decision support for intraoperative hypotension was being used, also known as 'usual care'. This is the three year period prior to the intervention period (the 'Intraoperative hypotension decision support' arm).
|
Hypotension Decision Support
n=4972 participants at risk
The intervention period. Several decision support elements are implemented to notify anesthesia providers: attending anesthesiologists and in-room anesthesia providers of intraoperative hypotension (threshold of a mean arterial pressure below 60 mmHg). Two types of decision support will be implemented: near real-time decision support and feedback emails.
Near real-time decision support elements will notify the anesthesia providers of a blood pressure drop below the threshold and display the associated increased risk of acute kidney injury. The notification is presented through the pager system for attending anesthesiologists and through the anesthesia information management system for the in-room anesthesia provider.
All providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension that is associated with an increased risk of organ injury due to organ ischemia.
|
|---|---|---|
|
Renal and urinary disorders
Acute Kidney Injury Stage I or greater
|
8.5%
1477/17463 • We analyzed adverse events in this patient population during their intraoperative course (adverse events sourced from our adverse event reporting system; from entry into OR to exit from OR), and during their hospitalization (source for mortality data; from hospital admission to hospital discharge).
We utilized our perioperative information management system to determine the number of adverse events that occurred associated with the patients' intraoperative course. We used our hospital registration system to determine all cause mortality for this patient population.
|
8.7%
435/4972 • We analyzed adverse events in this patient population during their intraoperative course (adverse events sourced from our adverse event reporting system; from entry into OR to exit from OR), and during their hospitalization (source for mortality data; from hospital admission to hospital discharge).
We utilized our perioperative information management system to determine the number of adverse events that occurred associated with the patients' intraoperative course. We used our hospital registration system to determine all cause mortality for this patient population.
|
|
Investigations
Mortality
|
3.1%
534/17463 • We analyzed adverse events in this patient population during their intraoperative course (adverse events sourced from our adverse event reporting system; from entry into OR to exit from OR), and during their hospitalization (source for mortality data; from hospital admission to hospital discharge).
We utilized our perioperative information management system to determine the number of adverse events that occurred associated with the patients' intraoperative course. We used our hospital registration system to determine all cause mortality for this patient population.
|
3.2%
158/4972 • We analyzed adverse events in this patient population during their intraoperative course (adverse events sourced from our adverse event reporting system; from entry into OR to exit from OR), and during their hospitalization (source for mortality data; from hospital admission to hospital discharge).
We utilized our perioperative information management system to determine the number of adverse events that occurred associated with the patients' intraoperative course. We used our hospital registration system to determine all cause mortality for this patient population.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place