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Clinical Trials/NCT05886387
NCT05886387
Completed
Not Applicable

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

Instituto de Investigacion Sanitaria La Fe4 sites in 4 countries3,836 target enrollmentSeptember 22, 2022

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.

Registry
clinicaltrials.gov
Start Date
September 22, 2022
End Date
December 25, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Instituto de Investigacion Sanitaria La Fe
Responsible Party
Sponsor

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 ]

Study Sites (4)

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