Open Lung Protective Extubation Following General Anesthesia (OLEXT-3)

Open Lung Protective Extubation Following General Anesthesia: the OLEXT-3 Trial

Perioperative respiratory complications are a major source of morbidity and mortality. Postoperative atelectasis plays a central role in their development. Protective "open lung" mechanical ventilation aims to minimize the occurrence of atelectasis during the perioperative period. Randomized controlled studies have been performed comparing various "open lung" ventilation protocols, but these studies report varying and conflicting effects. The interpretation of these studies is complicated by the absence of imagery supporting the pulmonary impact associated with the use of different ventilation strategies. Imaging studies suggest that the gain in pulmonary gas content in "open lung" ventilation regimens disappears within minutes after the extubation. Thus, the potential benefits of open-lung ventilation appear to be lost if, at the time of extubation, no measures are used to keep the lungs well aerated. Recent expert recommendations on good mechanical ventilation practices in the operating room conclude that there is actually no quality study on extubation.

Extubation is a very common practice for anesthesiologists as part of their daily clinical practice. It is therefore imperative to generate evidence on good clinical practice during anesthetic emergence in order to potentially identify an effective extubation strategy to reduce postoperative pulmonary complications.

Study Overview

• Status: Recruiting
• Conditions: Lung Injury; Anesthesia; Ventilator-Induced Lung Injury; Atelectasis; Intra-abdominal Surgery
• Intervention / Treatment: Other: Protective "open-lung" extubation; Other: Conventional extubation

Detailed Description

The aim of this study is to establish the feasibility of a multicenter randomized controlled clinical trial comparing two clinical strategies called "open lung" and "conventional" during extubation. The investigators also aim to estimate the rates of postoperative pulmonary complications in the two intervention groups.

METHODS

A multicenter internal pilot, prospective, randomized, allocation-concealed and controlled assessor-blinded study. Two hundred sixteen patients scheduled to undergo elective intra-abdominal surgery requiring general anesthesia and planned hospitalization at four Canadian hospitals, and at moderate or high risk of postoperative pulmonary complications according to the ARISCAT score will be recruited. Following the administration of standardized mechanical ventilation and after obtaining consent, participants will be randomly assigned to two groups:

Group A: Intervention group, "open lung" extubation strategy Group B: Control group, "conventional" extubation strategy.

The rate of adherence to the extubation protocol, the weekly patient recrutement rate and the 7-day postoperative pulmonary complications outcome completion rate will be measured. We will only report secondary efficacy outcome in aggregate as they will be rolled over to the definitive trial.

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Martin Girard, MD; Phone Number: 514-890-8000; Email: martin.girard@umontreal.ca
• Study Contact Backup: Name: Eva Amzallag, MSC; Phone Number: 514-890-8000; Email: eva.amzallag.chum@ssss.gouv.qc.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Not yet recruiting
      • The Ottawa Hospital
      • Sub-Investigator: Manoj Lalu, MD
      • Contact: Daniel I. McIsaac, MD; Phone Number: 613-761-4940; Email: dmcisaac@toh.ca
      • Contact: Manoj Lalu, MD; Email: mlalu@toh.ca
      • Principal Investigator: Daniel I. McIsaac, MD
    • Toronto, Ontario, Canada, M5B 1W8
      • Recruiting
      • Unity Health Network
      • Contact: Michael C. Sklar, MD; Phone Number: 416-864-5071; Email: michael.sklar@mail.utoronto.ca
      • Contact: Ashwin Sankar, MD; Email: ashwin.sankar@mail.utoronto.ca
      • Principal Investigator: Michael C. Sklar, MD
      • Sub-Investigator: Ashwin Sankar, MD
  • Quebec
    • Montreal, Quebec, Canada, H2X 0C1
      • Recruiting
      • Centre Hospitalier de l'Universite de Montreal (CHUM)
      • Sub-Investigator: Michaël Chassé, MD
      • Contact: Martin Girard, MD; Phone Number: 514-890-8000; Email: martin.girard@umontreal.ca
      • Contact: Eva Amzallag, MSC; Phone Number: 514-890-8000; Email: eva.amzallag.chum@ssss.gouv.qc.ca
      • Sub-Investigator: François Martin Carrier, MD
    • Québec, Quebec, Canada, G1V 4G2
      • Recruiting
      • CHU de Québec - Université Laval
      • Contact: Alexis F. Turgeon, MD; Phone Number: 66058 418-525-4444; Email: alexis.turgeon@fmed.ulaval.ca
      • Contact: Michael Verret, MD; Phone Number: 66847 418-525-4444; Email: michael.verret.med@ssss.gouv.qc.ca
      • Principal Investigator: Alexis F. Turgeon, MD
      • Sub-Investigator: Michael Verret, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients (18 years of age or over)
• Elective intra-abdominal surgery under general anesthesia.
• Moderate or high risk of postoperative pulmonary complication according to the ARISCAT score (score of 26 or more)
• Planned postoperative hospitalization

Exclusion Criteria:

• Expected or known difficult intubation according to the treating anesthesiologist
• Postoperative mechanical ventilation (planned or unplanned)
• General anesthesia performed outside the main operating room

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Open lung extubation; At the beginning of emergence, patients will be positioned with the head of the bed elevated to at least 30 degrees and the FiO2 will be set at 50%. At the resumption of spontaneous ventilation or earlier at the discretion of the anesthesiologist, the ventilator will be set to pressure support ventilation mode for the rest of the emergence procedure. The pressure support level will be adjusted to obtain a volume similar to the one used prior to emergence. PEEP will be left unchanged. Anesthesiologists will be instructed not to switch off the ventilator until the patient is extubated.	Other: Protective "open-lung" extubation; Emergence using 50% FiO2, semi-sitting position with pressure support ventilation and preserved PEEP
Active Comparator: Conventional extubation; At the beginning of emergence, patients will be positioned in a dorsal decubitus position and the FiO2 will be set at 100%. At the resumption of spontaneous ventilation or earlier at the discretion of the anesthesiologist, the ventilator will be switched off for the rest of the emergence procedure with the adjustable pressure-limiting valve open to atmosphere. Manual ventilation or assistance will be allowed, but the adjustable pressure-limiting valve will be reopened when pausing manual ventilation or assistance.	Other: Conventional extubation; Emergence using 100% FiO2, dorsal decubitus position with assistance or manual bag ventilation without PEEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average weekly patient recruitment rate	Achieve a weekly patient recruitment rate of 2 patients per week per center	Every week. At the end of the study (average 9 months) at the study level.
Protocol adherence rate	Assess adherence to a protocol during emergence from anesthesia, monitoring four criteria (proper positioning (dorsal decubitus or semi-sitting position), correct FiO2 (100% or 50%), appropriate ventilatory mode (manual or pressure support ventilation), and proper end-expiratory pressure (zero or preserved end-expiratory pressure), and noting deviations, with adherence defined as successful performance of all criteria during extubation.	At the end of surgery for individual assessments. At the end of the study (average 9 months) at the study level.
Postoperative pulmonary complications outcome completion rate	Postoperative pulmonary complications are defined as a composite endpoint that includes atelectasis, pneumonia, acute respiratory distress syndrome, and pulmonary aspiration, according to the StEP-COMPAC definition.	At postoperative day 7 for individual assessments. At the end of the study (average 9 months) at the study level.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of self-reported protocol adherence compared to directly observed protocol adherence	Following emergence from general anesthesia, treating anesthesiologists will complete the same four-point scoring sheet as the research assistant to self-report protocol adherence.	At the end of the surgery
Postoperative pulmonary complications	Postoperative pulmonary complications are defined as a composite endpoint that includes atelectasis, pneumonia, acute respiratory distress syndrome, and pulmonary aspiration, according to the StEP-COMPAC definition.	At postoperative day 7
Amount of supplemental oxygen administered following discharge from the post-anesthesia care unit	Obtained from the electronic medical record or the handwritten vital signs sheet. Calculated as %.h-1	At postoperative day 7 or hospital discharge (earliest of the two)
Quality of recovery	Evaluated using the QoR-15 questionnaire completed at the bedside.	At postoperative day 1
Discharge disposition	Location to which patient is discharged (e.g., home, long term care facility, etc.) Assessed during telephone interview and using administrative data. We will	At postoperative day 30
Days alive and out of hospital	Assessed during telephone interview and using administrative data	At postoperative day 30
Health-related quality of life	Evaluated using the EQ-5D-5L questionnaire completed during a telephone interview	At postoperative day 90

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lowest oxygen saturation post-extubation in the operating room	Lowest SpO2 in the operating room during emergence	At operating room exit
Time in minutes with oxygen saturation < 85% post-extubation in the operating room	Time with SpO2 < 85% in the operating room during emergence	At operating room exit
Re-intubation rate in the operating room and in the post-anesthesia care unit	Re-intubation in the operating room during emergence or in the post-anesthesia care unit	At discharge from the post-anesthesia care unit

Collaborators and Investigators

• Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
• Collaborators: University Health Network, Toronto; Canadian Institutes of Health Research (CIHR); CHU de Quebec-Universite Laval; The Ottawa Hospital
• Investigators: Principal Investigator: Martin Girard, MD, Centre Hospitalier de l'Universite de Montreal (CHUM)

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 28, 2024
• First Posted (Actual): March 6, 2024

Study Record Updates

• Last Update Posted (Actual): January 21, 2026
• Last Update Submitted That Met QC Criteria: January 19, 2026
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Respiratory Tract Diseases; Lung Diseases; Thoracic Injuries; Pulmonary Atelectasis; Lung Injury; Ventilator-Induced Lung Injury
• Other Study ID Numbers: MP-02-2024-12094

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: End-of-grant knowledge translation modalities will be used to reach other important stakeholders, researchers and members of the anesthesia community: scientific meetings, open access publication in a Canadian journal, and public presentations with patient partners. Knowledge diffusion on potential difficulties of conducting such trials (and solutions) will be transferred to the research community through meetings of the Canadian Perioperative Anesthesia Clinical Trial group (PACT). A methodological meeting will be organized with participating sites of both pilot and future efficacy phases to enhance protocol applicability before going forward to the efficacy phase. This plan will help recruit more Canadian centres for the efficacy trial and conduct the intervention in these centres.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No