Clinical trial NCT06296173: Open Lung Protective Extubation Following General Anesthesia
Official title: Open Lung Protective Extubation Following General Anesthesia: the OLEXT-3 Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intra-abdominal Surgery
Anesthesia
Lung Injury
Ventilator-Induced Lung Injury
Atelectasis
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
Collaborators: name: CHU de Quebec-Universite Laval
name: The Ottawa Hospital
name: University Health Network, Toronto
name: Canadian Institutes of Health Research (CIHR)
First posted: 2024-03-06
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Average weekly patient recruitment rate
timeFrame: Every week. At the end of the study (average 9 months) at the study level.
measure: Protocol adherence rate
timeFrame: At the end of surgery for individual assessments. At the end of the study (average 9 months) at the study level.
measure: Postoperative pulmonary complications outcome completion rate
timeFrame: At postoperative day 7 for individual assessments. At the end of the study (average 9 months) at the study level.
Secondary outcomes:
measure: Accuracy of self-reported protocol adherence compared to directly observed protocol adherence
timeFrame: At the end of the surgery
measure: Postoperative pulmonary complications
timeFrame: At postoperative day 7
measure: Amount of supplemental oxygen administered following discharge from the post-anesthesia care unit
timeFrame: At postoperative day 7 or hospital discharge (earliest of the two)
measure: Quality of recovery
timeFrame: At postoperative day 1
measure: Discharge disposition
timeFrame: At postoperative day 30
measure: Days alive and out of hospital
timeFrame: At postoperative day 30
measure: Health-related quality of life
timeFrame: At postoperative day 90
Other outcomes:
measure: Lowest oxygen saturation post-extubation in the operating room
timeFrame: At operating room exit
measure: Time in minutes with oxygen saturation < 85% post-extubation in the operating room
timeFrame: At operating room exit
measure: Re-intubation rate in the operating room and in the post-anesthesia care unit
timeFrame: At discharge from the post-anesthesia care unit
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Unity Health Network
state: Ontario
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
city: Québec
country: Canada
facility: CHU de Québec - Université Laval
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Martin Girard, MD
role: PRINCIPAL_INVESTIGATOR
References: