Open Lung Protective Extubation Following General Anesthesia

Official title

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

Overview

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.

Interventions

• Other Protective "open-lung" extubation
  Emergence using 50% FiO2, semi-sitting position with pressure support ventilation and preserved PEEP
• Other Conventional extubation
  Emergence using 100% FiO2, dorsal decubitus position with assistance or manual bag ventilation without PEEP

Primary outcome measures

• 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.]

Secondary outcome measures (7)

• Accuracy of self-reported protocol adherence compared to directly observed protocol adherence [Time frame: At the end of the surgery]
• Postoperative pulmonary complications [Time frame: At postoperative day 7]
• Amount of supplemental oxygen administered following discharge from the post-anesthesia care unit [Time frame: At postoperative day 7 or hospital discharge (earliest of the two)]
• Quality of recovery [Time frame: At postoperative day 1]
• Discharge disposition [Time frame: At postoperative day 30]
• Days alive and out of hospital [Time frame: At postoperative day 30]
• Health-related quality of life [Time frame: At postoperative day 90]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Canada · 4 centers

• The Ottawa Hospital — Ottawa
• Unity Health Network — Toronto
• Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal
• CHU de Québec - Université Laval — Québec

Identifiers

NCT: NCT06296173 · MP-02-2024-12094

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗