Open Lung Protective Extubation Following General Anesthesia

NCT06296173 | Recruiting DMC

• 1 other identifier: MP-02-2024-12094
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (7)

• Accuracy of self-reported protocol adherence compared to directly observed protocol adherence

  At the end of the surgery

• Postoperative pulmonary complications

  At postoperative day 7

• Amount of supplemental oxygen administered following discharge from the post-anesthesia care unit

  At postoperative day 7 or hospital discharge (earliest of the two)

• Quality of recovery

  At postoperative day 1

• Discharge disposition

  At postoperative day 30

Other Outcomes (3)

• Lowest oxygen saturation post-extubation in the operating room

  At operating room exit

• Time in minutes with oxygen saturation < 85% post-extubation in the operating room

  At operating room exit

• Re-intubation rate in the operating room and in the post-anesthesia care unit

  At discharge from the post-anesthesia care unit

Study Arms (2)

Open lung extubation

EXPERIMENTAL

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

Conventional extubation

ACTIVE COMPARATOR

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

Interventions

Conventional extubation OTHER

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

Conventional extubation

Protective "open-lung" extubation OTHER

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

Open lung extubation

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• CHU de Quebec-Universite Laval: collaborator
• Centre hospitalier de l'Université de Montréal (CHUM): lead
• The Ottawa Hospital: collaborator
• University Health Network, Toronto: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (4)

The Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

NOT YET RECRUITING

Unity Health Network

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 0C1, Canada

RECRUITING

CHU de Québec - Université Laval

Québec, Quebec, G1V 4G2, Canada

RECRUITING

MeSH Terms

Conditions

Lung Injury; Ventilator-Induced Lung Injury; Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries

Study Officials

• Martin Girard, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Girard, MD

CONTACT

514-890-8000; martin.girard@umontreal.ca

Eva Amzallag, MSC

CONTACT

514-890-8000; eva.amzallag.chum@ssss.gouv.qc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Until surgical closure, all will be blinded to treatment allocation. Only specific healthcare professionals (anesthesiologist, respiratory therapist, operating room nurses, unblinded research assistant) will be present during emergence to maintain blinding. Other healthcare team members will remain blinded. Outcome adjudicators, Executive and Steering committee members, and the data analyst will also be blinded. No mechanism for unblinding is planned, as both interventions follow the same diagnostic and treatment algorithms for adverse effects.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: During surgical closure, the definitive ARISCAT score and exclusion criteria will be assessed. Patients will be randomized equally (1:1) using web-based allocation-concealed methods, with stratification by center and ARISCAT risk category. An unblinded research assistant will reveal group allocation to the anesthesiologist and monitor the emergence procedure.

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 6, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 21, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)