Intra-abdominal SurgeryOLEXT-3NCT06296173
Open Lung Protective Extubation Following General Anesthesia
A study testing Protective "open-lung" extubation and Conventional extubation in people with Intra-abdominal Surgery and Anesthesia, run by Centre hospitalier de l'Université de Montréal (CHUM) at 5 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intra-abdominal Surgery, Anesthesia, Lung Injury
- What is being tested?
- Protective "open-lung" extubation and Conventional extubation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 5 sitesCanada
- Study dates
- 8 Oct 2024to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Expected or known difficult intubation according to the treating anesthesiologist
- Postoperative mechanical ventilation (planned or unplanned)
- General anesthesia performed outside the main operating room
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Canada5 sites, 5 recruiting
- Recruiting
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 0C1
Martin Girard, MD, 514-890-8000, martin.girard@umontreal.ca
Eva Amzallag, MSC, 514-890-8000, eva.amzallag.chum@ssss.gouv.qc.ca
- Not yet recruiting
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Daniel I. McIsaac, MD, 613-761-4940, dmcisaac@toh.ca
Manoj Lalu, MD, mlalu@toh.ca
- Recruiting
CHU de Québec - Université Laval
Québec, Quebec, G1V 4G2
Alexis F. Turgeon, MD, 418-525-4444 ext. 66058, alexis.turgeon@fmed.ulaval.ca
Michael Verret, MD, 418-525-4444 ext. 66847, michael.verret.med@ssss.gouv.qc.ca
- Recruiting
Unity Health Network
Toronto, Ontario, M5B 1W8
Michael C. Sklar, MD, 416-864-5071, michael.sklar@mail.utoronto.ca
Ashwin Sankar, MD, ashwin.sankar@mail.utoronto.ca
- Not yet recruiting
Royal Columbian Hospital
Vancouver, British Columbia, V3L 3W7
Michelle Mozel, Clinical Research Manager, M.Sc., CCRP, 604-520-4253, michelle.mozel@fraserhealth.ca
Susan Lee, MD
About this study
Official title: Open Lung Protective Extubation Following General Anesthesia: the OLEXT-3 Trial
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.
Read the 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.
- Conditions
- Intra-abdominal Surgery, Anesthesia, Lung Injury, Ventilator-Induced Lung Injury, Atelectasis
- Being tested
- Protective "open-lung" extubation, Conventional extubation
- Medical subject headings
- Lung Injury, Ventilator-Induced Lung Injury, Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protective "open-lung" extubationOther
Emergence using 50% FiO2, semi-sitting position with pressure support ventilation and preserved PEEP
Conventional extubationOther
Emergence using 100% FiO2, dorsal decubitus position with assistance or manual bag ventilation without PEEP
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Conventional extubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average weekly patient recruitment rate
Achieve a weekly patient recruitment rate of 2 patients per week per center
Measured: 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.
Measured: 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.
Measured: 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
Following emergence from general anesthesia, treating anesthesiologists will complete the same four-point scoring sheet as the research assistant to self-report protocol adherence.
Measured: At the end of the surgery
Postoperative pulmonary complications
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.
Measured: At postoperative day 7
Amount of supplemental oxygen administered following discharge from the post-anesthesia care unit
Obtained from the electronic medical record or the handwritten vital signs sheet. Calculated as %.h-1
Measured: At postoperative day 7 or hospital discharge (earliest of the two)
Quality of recovery
Evaluated using the QoR-15 questionnaire completed at the bedside.
Measured: At postoperative day 1
Discharge disposition
Location to which patient is discharged (e.g., home, long term care facility, etc.) Assessed during telephone interview and using administrative data. We will
Measured: At postoperative day 30
Days alive and out of hospital
Assessed during telephone interview and using administrative data
Measured: At postoperative day 30
Health-related quality of life
Evaluated using the EQ-5D-5L questionnaire completed during a telephone interview
Measured: At postoperative day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start8 Oct 2024
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-abdominal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de Quebec-Universite Laval, The Ottawa Hospital, University Health Network, Toronto, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Martin Girard, MD, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296173
- Sponsor's protocol ID
- MP-02-2024-12094
- Acronym
- OLEXT-3
- Status last verified
- Aug 2026
- First submitted
- 21 Feb 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: End-of-grant knowledge translation modalities will be used to reach other important stakeholders, researchers and members of the anesthesia community: scientific meetings, open access publication in a Canadian journal, and public presentations with patient partners. Knowledge diffusion on potential difficulties of conducting such trials (and solutions) will be transferred to the research community through meetings of the Canadian Perioperative Anesthesia Clinical Trial group (PACT). A methodological meeting will be organized with participating sites of both pilot and future efficacy phases to enhance protocol applicability before going forward to the efficacy phase. This plan will help recruit more Canadian centres for the efficacy trial and conduct the intervention in these centres.
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Lung Protective Extubation Following General Anesthesia: the OLEXT-3 Trial
- ClinicalTrials.gov ID
- NCT06296173
- Acronym / sponsor ID
- OLEXT-3 / MP-02-2024-12094
- Conditions
- Intra-abdominal Surgery, Anesthesia, Lung Injury, Ventilator-Induced Lung Injury, Atelectasis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- CHU de Quebec-Universite Laval, The Ottawa Hospital, University Health Network, Toronto, Canadian Institutes of Health Research (CIHR)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Open lung extubation | Experimental | Other: Protective "open-lung" extubationAt 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. |
| Conventional extubation | Active comparator | Other: Conventional extubationAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Expected or known difficult intubation according to the treating anesthesiologist
- Postoperative mechanical ventilation (planned or unplanned)
- General anesthesia performed outside the main operating room
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protective "open-lung" extubationEmergence using 50% FiO2, semi-sitting position with pressure support ventilation and preserved PEEP | Other | Open lung extubation |
| Conventional extubationEmergence using 100% FiO2, dorsal decubitus position with assistance or manual bag ventilation without PEEP | Other | Conventional extubation |
Primary outcome
Average weekly patient recruitment rate
Time frame: Every week. At the end of the study (average 9 months) at the study level.
Achieve a weekly patient recruitment rate of 2 patients per week per center
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.
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.
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.
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No. End-of-grant knowledge translation modalities will be used to reach other important stakeholders, researchers and members of the anesthesia community: scientific meetings, open access publication in a Canadian journal, and public presentations with patient partners. Knowledge diffusion on potential difficulties of conducting such trials (and solutions) will be transferred to the research community through meetings of the Canadian Perioperative Anesthesia Clinical Trial group (PACT). A methodological meeting will be organized with participating sites of both pilot and future efficacy phases to enhance protocol applicability before going forward to the efficacy phase. This plan will help recruit more Canadian centres for the efficacy trial and conduct the intervention in these centres.
Related trials for Intra-abdominal Surgery
Not yet recruitingObservational study
Cumulative Intra-Abdominal Pressure Burden and Acute Kidney Injury After Emergency Abdominal Surgery
Acute Kidney Injury, Intra-Abdominal Hypertension
Active, not recruitingObservational study
ORION Study: Mesh Position and Risk During Subsequent Minimally Invasive Abdominal Surgery
Ventral Hernia Repair
Not yet recruiting
Comparative Study Between Laparoscopic and Open Appendectomy of Complicated Appendicitis
Appendicitis, Perforated Appendicitis
Not yet recruitingPhase 2
Paricalcitol Versus Pirfenidone for Improving Surgical Resectability in Patients With Peritoneal Cancer
Peritoneal (Metastatic) Cancer, Peritoneal Carcinoma
RecruitingObservational study
Register With Patients in Which Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) Was Performed
Peritoneal Carcinomatosis, Pseudomyxoma Peritonei
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martin Girard, MD principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protective "open-lung" extubation and Conventional extubation in people with Intra-abdominal Surgery and Anesthesia, run by Centre hospitalier de l'Université de Montréal (CHUM) at 5 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Girard, MD (514-890-8000, martin.girard@umontreal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average weekly patient recruitment rate (time frame: Every week. At the end of the study (average 9 months) at the study level.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.