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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
270
Emergence using 50% FiO2, semi-sitting position with pressure support ventilation and preserved PEEP
Emergence using 100% FiO2, dorsal decubitus position with assistance or manual bag ventilation without PEEP
The Ottawa Hospital
Ottawa, Ontario, Canada
NOT_YET_RECRUITINGUnity Health Network
Toronto, Ontario, Canada
RECRUITINGCentre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
RECRUITINGCHU de Québec - Université Laval
Québec, Quebec, Canada
RECRUITINGAverage 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.
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.
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.
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 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.
Time frame: 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
Time frame: At postoperative day 7 or hospital discharge (earliest of the two)
Quality of recovery
Evaluated using the QoR-15 questionnaire completed at the bedside.
Time frame: 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
Time frame: At postoperative day 30
Days alive and out of hospital
Assessed during telephone interview and using administrative data
Time frame: At postoperative day 30
Health-related quality of life
Evaluated using the EQ-5D-5L questionnaire completed during a telephone interview
Time frame: At postoperative day 90
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.