Open lung extubation strategy for patients after abdominal surgery
Open Lung Protective Extubation Following General Anesthesia: the OLEXT-3 Trial
This study is testing if a new way to take patients off breathing machines after abdominal surgery can reduce lung problems compared to the usual method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 4 sites (Ottawa, Ontario and 3 other locations) |
| Trial ID | NCT06296173 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility of a multicenter randomized controlled trial comparing two extubation strategies: 'open lung' and 'conventional' in patients undergoing elective intra-abdominal surgery under general anesthesia. It will involve 216 adult patients at moderate or high risk of postoperative pulmonary complications, who will be randomly assigned to one of the two strategies. The study will measure adherence to the extubation protocol and the rates of postoperative pulmonary complications in both groups. The findings will help inform future definitive trials on the effectiveness of these strategies.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and over scheduled for elective intra-abdominal surgery with a moderate to high risk of postoperative pulmonary complications.
Not a fit: Patients who are expected to have difficult intubation or require postoperative mechanical ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved respiratory outcomes and reduced complications for patients undergoing abdominal surgery.
How similar studies have performed: Previous studies on 'open lung' ventilation have shown mixed results, indicating that this approach is still being explored and may offer novel insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ottawa, Ontario and 3 other locations
- The Ottawa Hospital — Ottawa, Ontario, Canada (Not_yet_recruiting)
- Unity Health Network — Toronto, Ontario, Canada (Recruiting)
- Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada (Recruiting)
- CHU de Québec - Université Laval — Québec, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Martin Girard, MD — Centre hospitalier de l'Université de Montréal (CHUM)
- Study coordinator: Martin Girard, MD
- Email: martin.girard@umontreal.ca
- Phone: 514-890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.