Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06296173

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

Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2026-01-21

270

Participants Needed

4

Research Sites

17 weeks

Total Duration

On this page

Sponsors

C

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

C

CHU de Quebec-Universite Laval

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the best extubation method to reduce lung complications after surgery. The study compares two techniques called "open lung" and "conventional" extubation in adults undergoing planned abdominal surgery with general anesthesia. The goal is to find out which method better keeps the lungs open and reduces breathing problems after surgery, as current evidence is unclear and imaging studies show benefits may be lost quickly after extubation. Participants will be randomly assigned to one of two groups: one using the "open lung" extubation strategy, where patients are semi-sitting with 50% oxygen and pressure support ventilation while keeping positive pressure in the lungs; the other using the "conventional" method, where patients lie on their backs with 100% oxygen and manual or assisted breathing without positive pressure. The study follows a controlled, double-blind design across several Canadian hospitals. During the study, researchers will monitor how well the extubation protocols are followed, the rate of patient recruitment each week, and the completion of lung complication assessments at seven days after surgery. Additional evaluations include recovery quality, oxygen needs after surgery, hospital discharge outcomes, and health-related quality of life up to 90 days. The study is planned to last about nine months, with careful tracking of lung function and patient progress throughout.

CONDITIONS

Brief Title

Open Lung Protective Extubation Following General Anesthesia

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients 18 years of age or older
  • Undergoing elective intra-abdominal surgery with general anesthesia
  • Moderate or high risk of postoperative pulmonary complications (ARISCAT score of 26 or more)
  • Planned hospitalization after surgery
Not Eligible

You will not qualify if you...

  • Known or expected difficult intubation as assessed by the anesthesiologist
  • Planned or unplanned postoperative mechanical ventilation
  • General anesthesia performed outside the main operating room

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - During surgery and immediate emergence period

Participants undergo general anesthesia for elective intra-abdominal surgery and receive either the "open lung" extubation strategy or the conventional extubation strategy during emergence from anesthesia.

1 surgical procedure visit

Follow-up

Duration - Up to 90 days after surgery

Participants are monitored for postoperative pulmonary complications and recovery outcomes including oxygen use, quality of recovery, discharge disposition, and health-related quality of life.

Approximately 3 visits: at postoperative days 1, 7, 30, and 90

Trial Site Locations

Total: 4 locations

1

The Ottawa Hospital

Ottawa, Ontario, Canada, K1H 8L6

Not Yet Recruiting

2

Unity Health Network

Toronto, Ontario, Canada, M5B 1W8

Actively Recruiting

3

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada, H2X 0C1

Actively Recruiting

4

CHU de Québec - Université Laval

Québec, Quebec, Canada, G1V 4G2

Actively Recruiting

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Research Team

M

Martin Girard, MD

E

Eva Amzallag, MSC

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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