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

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea; Respiratory Complication
• Intervention / Treatment: Drug: Sugammadex 100 MG/ML [Bridion]

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.

• Study Type: Interventional
• Enrollment (Anticipated): 13000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Eilon Gabel, MD; Phone Number: 310-267-8693; Email: egabel@mednet.ucla.edu
• Study Contact Backup: Name: Stephanie-Dee Sarovich, BS; Phone Number: 424-832-6842; Email: ssarovich@mednet.ucla.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • Recruiting
      • Ronald Reagan UCLA Medical Center
      • Principal Investigator: Ira Hofer, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Drug: Sugammadex 100 MG/ML [Bridion]; Sugammadex administered to patients within the clinical best practice pathway.; Other Names: Bridion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to "fitness for discharge" from the recovery room	The time the anesthesiologist places the discharge order	One year prior to study intervention to one year following implementation of study intervention
Incidence of hypoxemia in the PACU (oxygen saturation below 90%)	Documentation oxygen saturation below 90%	One year prior to study intervention to one year following implementation of study intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients who had intraoperative lung protective ventilation	Percentage of patients who had intraoperative lung protective ventilation prior to extubation	One year prior to study intervention to one year following implementation of study intervention
Incidence of hypoxemia in the PACU (oxygen saturation below 95%)	Documentation of oxygen saturation below 95%	One year prior to study intervention to one year following implementation of study intervention
Duration of supplemental oxygen needed by high-risk patients	Duration of supplemental oxygen needed by high-risk patients before and after intervention	One year prior to study intervention to one year following implementation of study intervention
Postoperative reintubation rate	Rate of postoperative reintubation	One year prior to study intervention to one year following implementation of study intervention
Number of patients with unplanned upgrade of care	Number of patients with unplanned upgrade of care	One year prior to study intervention to one year following implementation of study intervention
Percentage of patients who had Train of Four ratio measurement	Percentage of patients who had Train of Four ratio measurement prior to extubation	One year prior to study intervention to one year following implementation of study intervention

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2022
• Primary Completion (Anticipated): January 1, 2024
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: January 17, 2020
• First Submitted That Met QC Criteria: February 7, 2020
• First Posted (Actual): February 10, 2020

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Clinical Decision Support; Sugammadex; Respiratory Complication
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
• Other Study ID Numbers: Anes-Respiratory Dysfunction

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes