Trial Outcomes & Findings for Applying Best Clinical Practices to Patients at High Risk of Respiratory Complications (NCT NCT04263363)
NCT ID: NCT04263363
Last Updated: 2025-07-29
Results Overview
The time the anesthesiologist places the discharge order
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
12248 participants
Primary outcome timeframe
One year prior to study intervention to one year following implementation of study intervention
Results posted on
2025-07-29
Participant Flow
Pre-Trial Cohort Timeframe: Patients from 2015, before sugammadex was available on the market (pre-2016). Purpose: Served as a historical control group to compare outcomes before the introduction of sugammadex. Size: 6,824 patients. Post-Trial Cohort Timeframe: Patients enrolled between February 2022 and May 2024. Purpose: Identified and enrolled via an automated system using Best Practice Advisories (BPAs) in the EHR. Size: 5,424
Participant milestones
| Measure |
CDS Pathway
When the anesthesiologist completes the preoperative evaluation for a patient who is flagged as having either respiratory disease or OSA and will receive general anesthesia, the anesthesiologist will receive a pop-up window reminding them of the best practice guidelines for pulmonary management in high-risk patients. We anticipate that the pathway will suggest 1) use of sugammadex to reverse neuromuscular blockade if rocuronium was used 2) use of objective train of four monitoring throughout the case and to confirm reversal 3) use of a tidal volume of 6-8 cc/kg 4) use of at least 5 cmH2O of PEEP
Sugammadex 100 MG/ML \[Bridion\]: Sugammadex administered to patients within the clinical best practice pathway.
|
|---|---|
|
Pre-Trial Cohort
STARTED
|
6824
|
|
Pre-Trial Cohort
COMPLETED
|
6824
|
|
Pre-Trial Cohort
NOT COMPLETED
|
0
|
|
Post-Trial Cohort
STARTED
|
5424
|
|
Post-Trial Cohort
COMPLETED
|
5424
|
|
Post-Trial Cohort
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
Baseline characteristics by cohort
| Measure |
CDS Pathway
n=12 Participants
When the anesthesiologist completes the preoperative evaluation for a patient who is flagged as having either respiratory disease or OSA and will receive general anesthesia, the anesthesiologist will receive a pop-up window reminding them of the best practice guidelines for pulmonary management in high-risk patients. We anticipate that the pathway will suggest 1) use of sugammadex to reverse neuromuscular blockade if rocuronium was used 2) use of objective train of four monitoring throughout the case and to confirm reversal 3) use of a tidal volume of 6-8 cc/kg 4) use of at least 5 cmH2O of PEEP
Sugammadex 100 MG/ML \[Bridion\]: Sugammadex administered to patients within the clinical best practice pathway.
|
|---|---|
|
Age, Customized
≥18
|
12248 Participants
n=12 Participants
|
|
Sex/Gender, Customized
Pre-Trial Sex · Male
|
3249 Participants
n=6824 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Sex/Gender, Customized
Pre-Trial Sex · Female
|
3575 Participants
n=6824 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Sex/Gender, Customized
Pre-Trial Sex · Unknown
|
0 Participants
n=6824 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Sex/Gender, Customized
Post-Trial Sex · Male
|
2525 Participants
n=5424 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Sex/Gender, Customized
Post-Trial Sex · Female
|
2897 Participants
n=5424 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Sex/Gender, Customized
Post-Trial Sex · Unknown
|
2 Participants
n=5424 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Race/Ethnicity, Customized
Pre-Trial Race · American Indian or Alaska Native
|
36 Participants
n=6824 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Race/Ethnicity, Customized
Pre-Trial Race · Asian
|
605 Participants
n=6824 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Race/Ethnicity, Customized
Pre-Trial Race · Black or African American
|
578 Participants
n=6824 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Race/Ethnicity, Customized
Pre-Trial Race · Middle Eastern/North African
|
34 Participants
n=6824 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Race/Ethnicity, Customized
Pre-Trial Race · Native Hawaiian or Other Pacific Islander
|
37 Participants
n=6824 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Race/Ethnicity, Customized
Pre-Trial Race · Unknown / Not Specified
|
1198 Participants
n=6824 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Race/Ethnicity, Customized
Pre-Trial Race · White
|
4336 Participants
n=6824 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Race/Ethnicity, Customized
Post-Trial Race · American Indian or Alaska Native
|
62 Participants
n=5424 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Race/Ethnicity, Customized
Post-Trial Race · Asian
|
504 Participants
n=5424 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Race/Ethnicity, Customized
Post-Trial Race · Black or African American
|
379 Participants
n=5424 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Race/Ethnicity, Customized
Post-Trial Race · Middle Eastern/North African
|
119 Participants
n=5424 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Race/Ethnicity, Customized
Post-Trial Race · Native Hawaiian or Other Pacific Islander
|
29 Participants
n=5424 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Race/Ethnicity, Customized
Post-Trial Race · Unknown / Not Specified
|
1142 Participants
n=5424 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Race/Ethnicity, Customized
Post-Trial Race · White
|
3189 Participants
n=5424 Participants • Pre-Trial Cohort: Size: 6,824 patients. Post-Trial Cohort: Size: 5,424 patients.
|
|
Region of Enrollment
United States
|
12248 participants
n=12 Participants
|
PRIMARY outcome
Timeframe: One year prior to study intervention to one year following implementation of study interventionPopulation: Pre-Trial 6,824. Post-Trial 5,424.
The time the anesthesiologist places the discharge order
Outcome measures
| Measure |
CDS Pathway
n=12 Participants
When the anesthesiologist completes the preoperative evaluation for a patient who is flagged as having either respiratory disease or OSA and will receive general anesthesia, the anesthesiologist will receive a pop-up window reminding them of the best practice guidelines for pulmonary management in high-risk patients. We anticipate that the pathway will suggest 1) use of sugammadex to reverse neuromuscular blockade if rocuronium was used 2) use of objective train of four monitoring throughout the case and to confirm reversal 3) use of a tidal volume of 6-8 cc/kg 4) use of at least 5 cmH2O of PEEP
Sugammadex 100 MG/ML \[Bridion\]: Sugammadex administered to patients within the clinical best practice pathway.
|
|---|---|
|
Time to "Fitness for Discharge" From the Recovery Room
Pre-Trial
|
165.64 Minutes
Standard Deviation 89.69
|
|
Time to "Fitness for Discharge" From the Recovery Room
Post-Trial
|
154.60 Minutes
Standard Deviation 86.17
|
PRIMARY outcome
Timeframe: One year prior to study intervention to one year following implementation of study interventionPopulation: Pre-Trial 6,824. Post-Trial 5,424.
Documentation oxygen saturation below 90%
Outcome measures
| Measure |
CDS Pathway
n=12 Participants
When the anesthesiologist completes the preoperative evaluation for a patient who is flagged as having either respiratory disease or OSA and will receive general anesthesia, the anesthesiologist will receive a pop-up window reminding them of the best practice guidelines for pulmonary management in high-risk patients. We anticipate that the pathway will suggest 1) use of sugammadex to reverse neuromuscular blockade if rocuronium was used 2) use of objective train of four monitoring throughout the case and to confirm reversal 3) use of a tidal volume of 6-8 cc/kg 4) use of at least 5 cmH2O of PEEP
Sugammadex 100 MG/ML \[Bridion\]: Sugammadex administered to patients within the clinical best practice pathway.
|
|---|---|
|
Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 90%)
Pre-Trial
|
18 Participants
|
|
Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 90%)
Post-Trial
|
9 Participants
|
|
Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 90%)
No Incidence
|
12,221 Participants
|
SECONDARY outcome
Timeframe: One year prior to study intervention to one year following implementation of study interventionPopulation: This outcome was not measured due to impacted hospital regulations during COVID-19. Hospital regulations restricted this measurement to be taken as intake volume was low and therefore hospital administration deemed it uncollectable at the time. Therefore, this measurement was never completed during the duration of the study as our team were required to follow updated hospital regulations.
Percentage of patients who had intraoperative lung protective ventilation prior to extubation
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One year prior to study intervention to one year following implementation of study interventionPopulation: Pre-Trial 6,824. Post-Trial 5,424.
Documentation of oxygen saturation below 95%
Outcome measures
| Measure |
CDS Pathway
n=12 Participants
When the anesthesiologist completes the preoperative evaluation for a patient who is flagged as having either respiratory disease or OSA and will receive general anesthesia, the anesthesiologist will receive a pop-up window reminding them of the best practice guidelines for pulmonary management in high-risk patients. We anticipate that the pathway will suggest 1) use of sugammadex to reverse neuromuscular blockade if rocuronium was used 2) use of objective train of four monitoring throughout the case and to confirm reversal 3) use of a tidal volume of 6-8 cc/kg 4) use of at least 5 cmH2O of PEEP
Sugammadex 100 MG/ML \[Bridion\]: Sugammadex administered to patients within the clinical best practice pathway.
|
|---|---|
|
Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 95%)
Pre-Trial
|
421 Participants
|
|
Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 95%)
Post-Trial
|
1170 Participants
|
|
Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 95%)
No Incidence
|
10,657 Participants
|
SECONDARY outcome
Timeframe: One year prior to study intervention to one year following implementation of study interventionPopulation: This outcome was not measured due to impacted hospital regulations during COVID-19. Hospital regulations restricted this measurement to be taken as intake volume was low and therefore hospital administration deemed it uncollectable at the time. Therefore, this measurement was never completed during the duration of the study as our team were required to follow updated hospital regulations.
Duration of supplemental oxygen needed by high-risk patients before and after intervention
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One year prior to study intervention to one year following implementation of study interventionPopulation: Analysis was completed for Post-Trial participants equaling 5,424.
Rate of postoperative reintubation
Outcome measures
| Measure |
CDS Pathway
n=12248 Participants
When the anesthesiologist completes the preoperative evaluation for a patient who is flagged as having either respiratory disease or OSA and will receive general anesthesia, the anesthesiologist will receive a pop-up window reminding them of the best practice guidelines for pulmonary management in high-risk patients. We anticipate that the pathway will suggest 1) use of sugammadex to reverse neuromuscular blockade if rocuronium was used 2) use of objective train of four monitoring throughout the case and to confirm reversal 3) use of a tidal volume of 6-8 cc/kg 4) use of at least 5 cmH2O of PEEP
Sugammadex 100 MG/ML \[Bridion\]: Sugammadex administered to patients within the clinical best practice pathway.
|
|---|---|
|
Postoperative Reintubation Rate
Pre-Trial
|
13 Participants
|
|
Postoperative Reintubation Rate
Post-Trial
|
4 Participants
|
SECONDARY outcome
Timeframe: One year prior to study intervention to one year following implementation of study interventionPopulation: Pre-Trial 6,824. Post-Trial 5,424.
Number of patients with unplanned upgrade of care
Outcome measures
| Measure |
CDS Pathway
n=12248 Participants
When the anesthesiologist completes the preoperative evaluation for a patient who is flagged as having either respiratory disease or OSA and will receive general anesthesia, the anesthesiologist will receive a pop-up window reminding them of the best practice guidelines for pulmonary management in high-risk patients. We anticipate that the pathway will suggest 1) use of sugammadex to reverse neuromuscular blockade if rocuronium was used 2) use of objective train of four monitoring throughout the case and to confirm reversal 3) use of a tidal volume of 6-8 cc/kg 4) use of at least 5 cmH2O of PEEP
Sugammadex 100 MG/ML \[Bridion\]: Sugammadex administered to patients within the clinical best practice pathway.
|
|---|---|
|
Number of Patients With Unplanned Upgrade of Care
Pre-Trial
|
128 Participants
|
|
Number of Patients With Unplanned Upgrade of Care
Post-Trial
|
16 Participants
|
|
Number of Patients With Unplanned Upgrade of Care
No Incidence
|
12,104 Participants
|
SECONDARY outcome
Timeframe: One year prior to study intervention to one year following implementation of study interventionPopulation: Analysis was only completed for Post-Trial participants equaling 5,424. Analysis could not be collected for Pre-Trial group as the Pre-Trial group was collected retrospectively and this measurement was not implemented into care until the prospective collection of the Post-Trial group. Therefore, we could not obtain the Pre-Trial group's measurements as these measurements had never been collected to obtain retrospectively.
Percentage of patients who had Train of Four ratio measurement prior to extubation
Outcome measures
| Measure |
CDS Pathway
n=5424 Participants
When the anesthesiologist completes the preoperative evaluation for a patient who is flagged as having either respiratory disease or OSA and will receive general anesthesia, the anesthesiologist will receive a pop-up window reminding them of the best practice guidelines for pulmonary management in high-risk patients. We anticipate that the pathway will suggest 1) use of sugammadex to reverse neuromuscular blockade if rocuronium was used 2) use of objective train of four monitoring throughout the case and to confirm reversal 3) use of a tidal volume of 6-8 cc/kg 4) use of at least 5 cmH2O of PEEP
Sugammadex 100 MG/ML \[Bridion\]: Sugammadex administered to patients within the clinical best practice pathway.
|
|---|---|
|
Percentage of Patients Who Had Train of Four Ratio Measurement
|
2704 Participants
|
Adverse Events
CDS Pathway (Pre-Trial)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CDS Pathway (Post-Trial)
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CDS Pathway (Pre-Trial)
n=6824 participants at risk
When the anesthesiologist completes the preoperative evaluation for a patient who is flagged as having either respiratory disease or OSA and will receive general anesthesia, the anesthesiologist will receive a pop-up window reminding them of the best practice guidelines for pulmonary management in high-risk patients. We anticipate that the pathway will suggest 1) use of sugammadex to reverse neuromuscular blockade if rocuronium was used 2) use of objective train of four monitoring throughout the case and to confirm reversal 3) use of a tidal volume of 6-8 cc/kg 4) use of at least 5 cmH2O of PEEP
Sugammadex 100 MG/ML \[Bridion\]: Sugammadex administered to patients within the clinical best practice pathway.
|
CDS Pathway (Post-Trial)
n=5424 participants at risk
When the anesthesiologist completes the preoperative evaluation for a patient who is flagged as having either respiratory disease or OSA and will receive general anesthesia, the anesthesiologist will receive a pop-up window reminding them of the best practice guidelines for pulmonary management in high-risk patients. We anticipate that the pathway will suggest 1) use of sugammadex to reverse neuromuscular blockade if rocuronium was used 2) use of objective train of four monitoring throughout the case and to confirm reversal 3) use of a tidal volume of 6-8 cc/kg 4) use of at least 5 cmH2O of PEEP
Sugammadex 100 MG/ML \[Bridion\]: Sugammadex administered to patients within the clinical best practice pathway.
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6824 • Time of consent up to 48 hours post drug administration.
AEs collected for bradycardia, anaphylaxis, and reintubation cases.
|
0.07%
4/5424 • Number of events 4 • Time of consent up to 48 hours post drug administration.
AEs collected for bradycardia, anaphylaxis, and reintubation cases.
|
|
Immune system disorders
Anaphylaxis
|
0.00%
0/6824 • Time of consent up to 48 hours post drug administration.
AEs collected for bradycardia, anaphylaxis, and reintubation cases.
|
0.04%
2/5424 • Number of events 2 • Time of consent up to 48 hours post drug administration.
AEs collected for bradycardia, anaphylaxis, and reintubation cases.
|
|
Respiratory, thoracic and mediastinal disorders
Reintubation
|
0.00%
0/6824 • Time of consent up to 48 hours post drug administration.
AEs collected for bradycardia, anaphylaxis, and reintubation cases.
|
0.04%
2/5424 • Number of events 2 • Time of consent up to 48 hours post drug administration.
AEs collected for bradycardia, anaphylaxis, and reintubation cases.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place