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Applying Best Clinical Practices to Patients at High Risk of Respiratory Complications

A Prospective Digital Quality Improvement Project to Apply Best Clinical Practices to Patients at High Risk of Respiratory Complications

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04263363
Enrollment
12248
Registered
2020-02-10
Start date
2022-02-18
Completion date
2025-05-07
Last updated
2025-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Respiratory Complication

Keywords

Respiratory Complication, Clinical Decision Support, Sugammadex

Brief summary

The purpose of this study is to: 1. Perform a retrospective analysis on data contained in the UCLA Perioperative Data Warehouse on the incidence of respiratory dysfunction in the post-operative care unit (PACU) before and after the introduction of sugammadex into clinical practice. 2. Develop and implement a clinical best practice pathway designed to prevent postoperative respiratory complications in higher risk patients (such as those with OSA or preexisting respiratory disease) using education and clinical decision support in patients.

Detailed description

This will be a historical prospective comparative effectiveness clinical trial where the investigators plan to leverage their experience in extracting data from the EMR as well as creating robust CDS pathways in order to create and implement a pathway to promote use of best respiratory care in patients receiving general anesthesia who are at increased risk for postoperative respiratory dysfunction. The overall study will consist of two parts: 1. Retrospective data analysis: The investigators will utilize the Perioperative Data Warehouse, a custom-built data warehouse, to study the effect of the introduction of sugammadex, a direct reversal agent for rocuronium, into clinical practice on time to fitness for discharge from the recovery room, as noted by the time the anesthesiologist places the discharge order, before and after intervention and postoperative respiratory dysfunction (as defined as duration of oxygen saturation below 90% in the PACU). 2. Creation and implementation of a pathway to prevent postoperative respiratory dysfunction: The investigators will design and implement a perioperative decision support system which will identify high-risk patients and provide best practice recommendations via electronic clinical decision support reminders. Creation and implementation of a pathway to prevent postoperative respiratory dysfunction: In order to improve outcomes for high-risk patients who receive general anesthesia and paralysis the investigators will design and implement a perioperative decision support system which will identify high-risk patients and provide best practice recommendations via electronic clinical decision support reminders. While the exact parameters of the pathway will be designed based upon feedback from a group of quality leaders in the department, in general the pathway will function as follows: 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 an alert reminding them of the best practice guidelines for pulmonary management in high-risk patients. As part of the study roll-out the investigators will present these guidelines with their quality committee, but anticipate that they 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. The investigators anticipate running the prospective portion of the study for a one year data collection period. Specifically, they will allow a one month wash out period for pathway go live, followed by one year of data collection during which the pathway is live. STUDY PROCEDURES Pathway Design The design of the pathway will undergo a well-established process that is designed to ensure buy-in and support from a large variety of providers within the Department of Anesthesiology and Perioperative Medicine at UCLA. The investigators will create a core group of individuals who represent key stakeholders in quality, informatics, and clinical decision making throughout our department. This group will be in charge of reviewing the existing literature and creating the pathway guidelines and associated decision support. The decision support will consist of preoperative alerts for high risk patients, intraoperative reminders for events such as ventilator settings and reversal as well as postoperative feedback on performance of identified best practices and outcomes. This pathway will include the recommendation of the use of sugammadex to reverse neuromuscular blockade and use of objective train of four (TOF) monitoring in high-risk individuals. This core group will then present the recommended pathway for approval to our quarterly Quality Council and then broader Faculty Meetings for approval. The investigators estimate that the total time for pathway design and creation will be approximately 6 months. Pathway Implementation After approval, the investigators will work with the EMR build team in order to ensure the necessary modification to the EMR. After the modifications are complete, the investigators will establish a go-live date. After an initial period during which the investigators will accommodate feedback and ensure that the modifications were made successfully, no further modifications to the respiratory pathway will be made. The investigators plan to keep this pathway in place for at least one year (the study period). Data Collection and Analysis As noted above, the team has the ability to automatically collect the data from the EMR for analysis purposes. After the one year implementation period investigators will extract the data elements noted above for the study period as well as an equivalent period prior to pathway implementation. The data will be analyzed for the overall application of best practices before and after as well as a change in primary and secondary outcomes.

Interventions

Sugammadex administered to patients within the clinical best practice pathway.

Sponsors

Merck Sharp & Dohme LLC
CollaboratorINDUSTRY
University of California, Los Angeles
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Historical prospective comparative effectiveness clinical trial

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* UCLA Ronald Reagan or Santa Monica patients aged 18 and older who had a general anesthetic with either rocuronium or vecuronium. * Patients who receive sugammadex from the specified study supply

Exclusion criteria

* Patients under the age of 18 * Patients with a preoperative glomerular filtration rate less than 30 or on hemodialysis * Patients with known hypersensitivity to any of the following: rocuronium, vecuronium, sugammadex, neostigmine or glycopyrrolate * Patients with known neuromuscular disease * Patients who remain intubated after surgery or leave the operating room with a tracheostomy in-situ * Patients who did not receive reversal of neuromuscular blockade (with neostigmine in the pre-period or sugammadex in the post-period).

Design outcomes

Primary

MeasureTime frameDescription
Time to Fitness for Discharge From the Recovery RoomOne year prior to study intervention to one year following implementation of study interventionThe time the anesthesiologist places the discharge order
Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 90%)One year prior to study intervention to one year following implementation of study interventionDocumentation oxygen saturation below 90%

Secondary

MeasureTime frameDescription
Duration of Supplemental Oxygen Needed by High-risk PatientsOne year prior to study intervention to one year following implementation of study interventionDuration of supplemental oxygen needed by high-risk patients before and after intervention
Postoperative Reintubation RateOne year prior to study intervention to one year following implementation of study interventionRate of postoperative reintubation
Percentage of Patients Who Had Intraoperative Lung Protective VentilationOne year prior to study intervention to one year following implementation of study interventionPercentage of patients who had intraoperative lung protective ventilation prior to extubation
Percentage of Patients Who Had Train of Four Ratio MeasurementOne year prior to study intervention to one year following implementation of study interventionPercentage of patients who had Train of Four ratio measurement prior to extubation
Number of Patients With Unplanned Upgrade of CareOne year prior to study intervention to one year following implementation of study interventionNumber of patients with unplanned upgrade of care
Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 95%)One year prior to study intervention to one year following implementation of study interventionDocumentation of oxygen saturation below 95%

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

ArmCount
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.
12
Total12

Baseline characteristics

CharacteristicCDS Pathway
Age, Customized
≥18
12248 Participants
Race/Ethnicity, Customized
Post-Trial Race
American Indian or Alaska Native
62 Participants
Race/Ethnicity, Customized
Post-Trial Race
Asian
504 Participants
Race/Ethnicity, Customized
Post-Trial Race
Black or African American
379 Participants
Race/Ethnicity, Customized
Post-Trial Race
Middle Eastern/North African
119 Participants
Race/Ethnicity, Customized
Post-Trial Race
Native Hawaiian or Other Pacific Islander
29 Participants
Race/Ethnicity, Customized
Post-Trial Race
Unknown / Not Specified
1142 Participants
Race/Ethnicity, Customized
Post-Trial Race
White
3189 Participants
Race/Ethnicity, Customized
Pre-Trial Race
American Indian or Alaska Native
36 Participants
Race/Ethnicity, Customized
Pre-Trial Race
Asian
605 Participants
Race/Ethnicity, Customized
Pre-Trial Race
Black or African American
578 Participants
Race/Ethnicity, Customized
Pre-Trial Race
Middle Eastern/North African
34 Participants
Race/Ethnicity, Customized
Pre-Trial Race
Native Hawaiian or Other Pacific Islander
37 Participants
Race/Ethnicity, Customized
Pre-Trial Race
Unknown / Not Specified
1198 Participants
Race/Ethnicity, Customized
Pre-Trial Race
White
4336 Participants
Region of Enrollment
United States
12248 participants
Sex/Gender, Customized
Post-Trial Sex
Female
2897 Participants
Sex/Gender, Customized
Post-Trial Sex
Male
2525 Participants
Sex/Gender, Customized
Post-Trial Sex
Unknown
2 Participants
Sex/Gender, Customized
Pre-Trial Sex
Female
3575 Participants
Sex/Gender, Customized
Pre-Trial Sex
Male
3249 Participants
Sex/Gender, Customized
Pre-Trial Sex
Unknown
0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 6,8240 / 5,424
other
Total, other adverse events
0 / 6,8240 / 5,424
serious
Total, serious adverse events
0 / 6,8248 / 5,424

Outcome results

Primary

Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 90%)

Documentation oxygen saturation below 90%

Time frame: One year prior to study intervention to one year following implementation of study intervention

Population: Pre-Trial 6,824. Post-Trial 5,424.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
CDS PathwayIncidence of Hypoxemia in the PACU (Oxygen Saturation Below 90%)Pre-Trial18 Participants
CDS PathwayIncidence of Hypoxemia in the PACU (Oxygen Saturation Below 90%)Post-Trial9 Participants
CDS PathwayIncidence of Hypoxemia in the PACU (Oxygen Saturation Below 90%)No Incidence12,221 Participants
Primary

Time to Fitness for Discharge From the Recovery Room

The time the anesthesiologist places the discharge order

Time frame: One year prior to study intervention to one year following implementation of study intervention

Population: Pre-Trial 6,824. Post-Trial 5,424.

ArmMeasureGroupValue (MEAN)Dispersion
CDS PathwayTime to Fitness for Discharge From the Recovery RoomPre-Trial165.64 MinutesStandard Deviation 89.69
CDS PathwayTime to Fitness for Discharge From the Recovery RoomPost-Trial154.60 MinutesStandard Deviation 86.17
Secondary

Duration of Supplemental Oxygen Needed by High-risk Patients

Duration of supplemental oxygen needed by high-risk patients before and after intervention

Time frame: One year prior to study intervention to one year following implementation of study intervention

Population: 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.

Secondary

Incidence of Hypoxemia in the PACU (Oxygen Saturation Below 95%)

Documentation of oxygen saturation below 95%

Time frame: One year prior to study intervention to one year following implementation of study intervention

Population: Pre-Trial 6,824. Post-Trial 5,424.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
CDS PathwayIncidence of Hypoxemia in the PACU (Oxygen Saturation Below 95%)Pre-Trial421 Participants
CDS PathwayIncidence of Hypoxemia in the PACU (Oxygen Saturation Below 95%)Post-Trial1170 Participants
CDS PathwayIncidence of Hypoxemia in the PACU (Oxygen Saturation Below 95%)No Incidence10,657 Participants
Secondary

Number of Patients With Unplanned Upgrade of Care

Number of patients with unplanned upgrade of care

Time frame: One year prior to study intervention to one year following implementation of study intervention

Population: Pre-Trial 6,824. Post-Trial 5,424.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
CDS PathwayNumber of Patients With Unplanned Upgrade of CarePre-Trial128 Participants
CDS PathwayNumber of Patients With Unplanned Upgrade of CarePost-Trial16 Participants
CDS PathwayNumber of Patients With Unplanned Upgrade of CareNo Incidence12,104 Participants
Secondary

Percentage of Patients Who Had Intraoperative Lung Protective Ventilation

Percentage of patients who had intraoperative lung protective ventilation prior to extubation

Time frame: One year prior to study intervention to one year following implementation of study intervention

Population: 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.

Secondary

Percentage of Patients Who Had Train of Four Ratio Measurement

Percentage of patients who had Train of Four ratio measurement prior to extubation

Time frame: One year prior to study intervention to one year following implementation of study intervention

Population: 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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
CDS PathwayPercentage of Patients Who Had Train of Four Ratio Measurement2704 Participants
Secondary

Postoperative Reintubation Rate

Rate of postoperative reintubation

Time frame: One year prior to study intervention to one year following implementation of study intervention

Population: Analysis was completed for Post-Trial participants equaling 5,424.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
CDS PathwayPostoperative Reintubation RatePre-Trial13 Participants
CDS PathwayPostoperative Reintubation RatePost-Trial4 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026