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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22435 participants

Primary outcome timeframe

Within 7 days after surgery

Results posted on

2019-05-16

Participant Flow

Participant milestones

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

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 surgery

Population: 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

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 surgery

Population: 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

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 days

Population: 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

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 surgery

Population: 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

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 surgery

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 surgery

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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 hours

Population: 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

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

Serious events: 1811 serious events
Other events: 0 other events
Deaths: 534 deaths

Hypotension Decision Support

Serious events: 541 serious events
Other events: 0 other events
Deaths: 158 deaths

Serious adverse events

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

Jonathan Wanderer

Vanderbilt University Medical Center

Phone: 615-536-5194

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place