Open Lung Protective Extubation Following General Anesthesia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre hospitalier de l'Université de Montréal (CHUM)
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Protective "open-lung" extubation
Other interventionEmergence using 50% FiO2, semi-sitting position with pressure support ventilation and preserved PEEP
Conventional extubation
Other interventionEmergence using 100% FiO2, dorsal decubitus position with assistance or manual bag ventilation without PEEP
Treatment groups
270 Participants
are divided into 2 treatment groupsGroup A: Open lung extubationExperimental treatment 1 intervention
Group B: Conventional extubationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Average weekly patient recruitment rate
Achieve a weekly patient recruitment rate of 2 patients per week per center
Time frame
Every week. At the end of the study (average 9 months) at the study level.2
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.
Time frame
At the end of surgery for individual assessments. At the end of the study (average 9 months) at the study level.3
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.
Time frame
At postoperative day 7 for individual assessments. At the end of the study (average 9 months) at the study level.Secondary outcomes
1
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.
Time frame
At the end of the surgery2
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.
Time frame
At postoperative day 73
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
Time frame
At postoperative day 7 or hospital discharge (earliest of the two)4
Quality of recovery
Evaluated using the QoR-15 questionnaire completed at the bedside.
Time frame
At postoperative day 1Other outcomes
1
Lowest oxygen saturation post-extubation in the operating room
Lowest SpO2 in the operating room during emergence
Time frame
At operating room exit2
Time in minutes with oxygen saturation < 85% post-extubation in the operating room
Time with SpO2 \< 85% in the operating room during emergence
Time frame
At operating room exit3
Re-intubation rate in the operating room and in the post-anesthesia care unit
Re-intubation in the operating room during emergence or in the post-anesthesia care unit
Time frame
At discharge from the post-anesthesia care unitSponsors and contacts
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Centre hospitalier de l'Université de Montréal (CHUM)
Lead sponsor
CHU de Quebec-Universite Laval
Collaborator
The Ottawa Hospital
Collaborator
University Health Network, Toronto
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Source ClinicalTrials.gov