protocolSection identificationModule nctId: NCT06296173, orgStudyIdInfo id: MP-02-2024-12094, briefTitle: Open Lung Protective Extubation Following General Anesthesia, acronym: OLEXT-3, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2025-12-01, completionDateStruct date: 2026-04-01, studyFirstPostDateStruct date: 2024-03-06, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Centre hospitalier de l'Université de Montréal (CHUM), class: OTHER, collaborators name: CHU de Quebec-Universite Laval, collaborators name: The Ottawa Hospital, collaborators name: University Health Network, Toronto, collaborators name: Canadian Institutes of Health Research (CIHR), descriptionModule briefSummary: 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., conditionsModule conditions: Intra-abdominal Surgery, conditions: Anesthesia, conditions: Lung Injury, conditions: Ventilator-Induced Lung Injury, conditions: Atelectasis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: 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., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Until surgical closure, all will be blinded to treatment allocation. Only specific healthcare professionals (anesthesiologist, respiratory therapist, operating room nurses, unblinded research assistant) will be present during emergence to maintain blinding. Other healthcare team members will remain blinded. Outcome adjudicators, Executive and Steering committee members, and the data analyst will also be blinded. No mechanism for unblinding is planned, as both interventions follow the same diagnostic and treatment algorithms for adverse effects., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 216, type: ESTIMATED, armsInterventionsModule interventions name: Protective "open-lung" extubation, interventions name: Conventional extubation, outcomesModule primaryOutcomes measure: Average weekly patient recruitment rate, primaryOutcomes measure: Protocol adherence rate, primaryOutcomes measure: Postoperative pulmonary complications outcome completion rate, secondaryOutcomes measure: Accuracy of self-reported protocol adherence compared to directly observed protocol adherence, secondaryOutcomes measure: Postoperative pulmonary complications, secondaryOutcomes measure: Amount of supplemental oxygen administered following discharge from the post-anesthesia care unit, secondaryOutcomes measure: Quality of recovery, secondaryOutcomes measure: Discharge disposition, secondaryOutcomes measure: Days alive and out of hospital, secondaryOutcomes measure: Health-related quality of life, otherOutcomes measure: Lowest oxygen saturation post-extubation in the operating room, otherOutcomes measure: Time in minutes with oxygen saturation < 85% post-extubation in the operating room, otherOutcomes measure: Re-intubation rate in the operating room and in the post-anesthesia care unit, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Ottawa Hospital, city: Ottawa, state: Ontario, zip: K1H 8L6, country: Canada, contacts name: Daniel I. McIsaac, MD, role: CONTACT, phone: 613-761-4940, email: dmcisaac@toh.ca, contacts name: Manoj Lalu, MD, role: CONTACT, email: mlalu@toh.ca, contacts name: Daniel I. McIsaac, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Manoj Lalu, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.41117, lon: -75.69812, locations facility: Unity Health Network, city: Toronto, state: Ontario, zip: M5B 1W8, country: Canada, contacts name: Michael C. Sklar, MD, role: CONTACT, phone: 416-864-5071, email: michael.sklar@mail.utoronto.ca, contacts name: Ashwin Sankar, MD, role: CONTACT, email: ashwin.sankar@mail.utoronto.ca, contacts name: Michael C. Sklar, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Ashwin Sankar, MD, role: SUB_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Centre Hospitalier de l'Université de Montréal (CHUM), city: Montréal, state: Quebec, zip: H2X 0C1, country: Canada, contacts name: Martin Girard, MD, role: CONTACT, phone: 514-890-8000, email: martin.girard@umontreal.ca, contacts name: Eva Amzallag, MSC, role: CONTACT, phone: 514-890-8000, email: eva.amzallag.chum@ssss.gouv.qc.ca, contacts name: Michael Chassé, MD, role: SUB_INVESTIGATOR, contacts name: François Martin Carrier, MD, role: SUB_INVESTIGATOR, geoPoint lat: 45.50884, lon: -73.58781, locations facility: CHU de Québec - Université Laval, city: Québec, zip: G1V 4G2, country: Canada, contacts name: Alexis F. Turgeon, MD, role: CONTACT, phone: 418-525-4444, phoneExt: 66058, email: alexis.turgeon@fmed.ulaval.ca, contacts name: Michael Verret, MD, role: CONTACT, phone: 418-525-4444, phoneExt: 66847, email: michael.verret.med@ssss.gouv.qc.ca, contacts name: Alexis F. Turgeon, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Michael Verret, MD, role: SUB_INVESTIGATOR, geoPoint lat: 46.81228, lon: -71.21454, hasResults: False