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Effect of Intraoperative PEEP With Recruitment Manoeuvres on the Occurrence of Postoperative Pulmonary Complications During General Anaesthesia--a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation
The investigators designed a protocol for a Bayesian unplanned posthoc analysis using the pooled dataset from three large randomized clinical trials. The primary endpoint will be a composite of postoperative pulmonary complications (PPC) within the first seven postoperative days, which reflects the primary endpoint of the original studies. The investigators will carry out a reanalysis of the harmonised database using Bayesian statistics.
Background: Using the frequentist approach, a recent meta-analysis of three randomized clinical trials in patients undergoing intraoperative ventilation during general anesthesia for major surgery. failed to show the benefit of ventilation that uses high positive end expiratory pressure with recruitment maneuvers when compared to ventilation that uses low positive end-expiratory pressure without recruitment maneuvers. Methods: The investigators designed a protocol for a Bayesian analysis using the pooled dataset. The multilevel Bayesian logistic model will use the individual patient data. Prior distributions will be prespecified to represent a varying level of skepticism for the effect estimate. The primary endpoint will be a composite of postoperative pulmonary complications (PPC) within the first seven postoperative days, which reflects the primary endpoint of the original studies. The investigators preset a range of practical equivalence to assess the futility of the intervention with an interval of odds ratio (OR) between 0.9 and 1.1 and assess how much of the 95% of highest density interval (HDI) falls between the region of practical equivalence.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hospital Israelita Albert Einstein
São Paulo, Brazil
IRCCS San Martino Policlinico Hospital
Genoa, Italy
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Amsterdam, Netherlands
Hospital Clinic
Barcelona, Spain
Start Date
September 22, 2022
Primary Completion Date
December 10, 2023
Completion Date
December 25, 2023
Last Updated
October 9, 2024
3,836
ACTUAL participants
High PEEP + Recruitment maneuvers
OTHER
Standard PEEP. Low positive end-expriatory pressure
OTHER
Lead Sponsor
Instituto de Investigacion Sanitaria La Fe
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT04246463