Open Lung Protective Extubation Following General Anesthesia

NCT ID: NCT06296173

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-08
• Study Completion Date: 2027-04-01

Brief Summary

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.

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.

Conditions

Intra-abdominal Surgery; Anesthesia; Lung Injury; Ventilator-Induced Lung Injury; Atelectasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Protective "open-lung" extubation

Intervention Type: OTHER

Emergence using 50% FiO2, semi-sitting position with pressure support ventilation and preserved PEEP

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.

Group Type: ACTIVE_COMPARATOR

Conventional extubation

Intervention Type: OTHER

Emergence using 100% FiO2, dorsal decubitus position with assistance or manual bag ventilation without PEEP

Interventions

Protective "open-lung" extubation

Emergence using 50% FiO2, semi-sitting position with pressure support ventilation and preserved PEEP

Intervention Type: OTHER

Conventional extubation

Emergence using 100% FiO2, dorsal decubitus position with assistance or manual bag ventilation without PEEP

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Quebec-Universite Laval

OTHER

Sponsor Role: collaborator

The Ottawa Hospital

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

Centre hospitalier de l'Université de Montréal (CHUM)

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Girard, MD

Role: PRINCIPAL_INVESTIGATOR

Centre hospitalier de l'Université de Montréal (CHUM)

Locations

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status: NOT_YET_RECRUITING

Unity Health Network

Toronto, Ontario, Canada

Site Status: RECRUITING

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Site Status: RECRUITING

CHU de Québec - Université Laval

Québec, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Martin Girard, MD

Role: CONTACT

martin.girard@umontreal.ca

514-890-8000

Eva Amzallag, MSC

Role: CONTACT

eva.amzallag.chum@ssss.gouv.qc.ca

514-890-8000

Facility Contacts

Daniel I. McIsaac, MD

Role: primary

dmcisaac@toh.ca

613-761-4940

Manoj Lalu, MD

Role: backup

mlalu@toh.ca

Michael C. Sklar, MD

Role: primary

michael.sklar@mail.utoronto.ca

416-864-5071

Ashwin Sankar, MD

Role: backup

ashwin.sankar@mail.utoronto.ca

Martin Girard, MD

Role: primary

martin.girard@umontreal.ca

514-890-8000

Eva Amzallag, MSC

Role: backup

eva.amzallag.chum@ssss.gouv.qc.ca

514-890-8000

Alexis F. Turgeon, MD

Role: primary

alexis.turgeon@fmed.ulaval.ca

418-525-4444 ext. 66058

Michael Verret, MD

Role: backup

michael.verret.med@ssss.gouv.qc.ca

418-525-4444 ext. 66847

Other Identifiers

MP-02-2024-12094

Identifier Type: -

Identifier Source: org_study_id