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

NCT04263363 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Anes-Respiratory Dysfunction
• Study Type: interventional
• Target: 12,248
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to:

1. 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. 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.

Conditions

Respiratory Complication; Obstructive Sleep Apnea

Keywords

Respiratory Complication; Clinical Decision Support; Sugammadex

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Percentage of Patients Who Had Intraoperative Lung Protective Ventilation

  One year prior to study intervention to one year following implementation of study intervention

• Incidence of Hypoxemia in the PACU (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

  One year prior to study intervention to one year following implementation of study intervention

• Postoperative Reintubation Rate

  One year prior to study intervention to one year following implementation of study intervention

• Number of Patients With Unplanned Upgrade of Care

  One year prior to study intervention to one year following implementation of study intervention

Study Arms (1)

CDS pathway

EXPERIMENTAL

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]

Interventions

Sugammadex 100 MG/ML [Bridion] DRUG

Sugammadex administered to patients within the clinical best practice pathway.

Also known as: Bridion

CDS pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Sugammadex

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

gamma-Cyclodextrins; Cyclodextrins; Macrocyclic Compounds; Polycyclic Compounds; Dextrins; Starch; Glucans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Dr. Eilon Gabel, MD
• Organization: UCLA

EGabel@mednet.ucla.edu

310-267-8693

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Historical prospective comparative effectiveness clinical trial

Study Record Dates

• First Submitted: January 17, 2020
• First Posted: February 10, 2020
• Study Start: February 18, 2022
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2025
• Last Updated: July 29, 2025
• Results First Posted: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)