Recruiting

Lung Protective Extubation

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT06296173

Conditions

Intra-abdominal Surgery

Anesthesia

Lung Injury

Ventilator-Induced Lung Injury

Atelectasis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Protective "open-lung" extubation

Conventional extubation

Study Details

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.

Conditions

Intra-abdominal Surgery

Anesthesia

Lung Injury

Ventilator-Induced Lung Injury

Atelectasis

Study ID

NCT06296173

Start date

Oct 8, 2024

Status verified date

Aug, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Protective "open-lung" extubation

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

Conventional extubation

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

Primary outcome measure

  • Average weekly patient recruitment rate [ Time Frame: Every week. At the end of the study (average 9 months) at the study level. ]
  • Protocol adherence rate [ Time Frame: 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 [ Time Frame: At postoperative day 7 for individual assessments. At the end of the study (average 9 months) at the study level. ]

Central Contacts and Locations

Locations

Unity Health Network

Recruiting

Toronto, Ontario, Canada, M5B 1W8

Contacts

Principal Investigator:

Michael C. Sklar, MD

Centre Hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Contacts

CHU de Québec - Université Laval

Recruiting

Québec, Quebec, Canada, G1V 4G2

Contacts

Principal Investigator:

Alexis F. Turgeon, MD

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2026-08-17.