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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Mechanical Ventilation Complication
- Sponsor
- Instituto de Investigacion Sanitaria La Fe
- Enrollment
- 3836
- Locations
- 4
- Primary Endpoint
- Incidence of postoperative pulmonary complications
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Planned for major surgery
- •At risk for pulmonary complications
Exclusion Criteria
- •Planned thoracic surgery .
- •Unscheduled surgery (i.e., urgent, or emergent surgeries)
Outcomes
Primary Outcomes
Incidence of postoperative pulmonary complications
Time Frame: Until day seven or hospital discharge, whichever comes first ]