a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation

Completed

• Conditions: Pulmonary Complication; Postoperative Complications; Mechanical Ventilation Complication; Surgery
• Interventions: Other: High PEEP + Recruitment maneuvers; Other: Standard PEEP. Low positive end-expriatory pressure

• Registration Number: NCT05886387
• Lead Sponsor: Instituto de Investigacion Sanitaria La Fe

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.

Study Timeline

• Study Start: 2022-09-22
• Study First Submitted: 2023-05-23
• Study First Submitted QC: 2023-05-23
• Study First Posted: 2023-06-02
• Primary Completion: 2023-12-10
• Study Completion: 2023-12-25
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3836

Inclusion Criteria

• Planned for major surgery
• At risk for pulmonary complications

Exclusion Criteria

• Planned thoracic surgery .
• Unscheduled surgery (i.e., urgent, or emergent surgeries)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
High PEEP + Recruitment Maneuvers	High PEEP + Recruitment maneuvers	Patients who received intraoperatively high PEEP (10-12 cmH2O) after a recruitment maneuvers as per the original study protocol
Standard PEEP	Standard PEEP. Low positive end-expriatory pressure	Patients who received intraoperatively standard PEEP (0-5 cmH2O) without recruitment maneuvers

Primary Outcome Measures

Name	Time	Method
Incidence of postoperative pulmonary complications	Until day seven or hospital discharge, whichever comes first ]

Trial Locations

Locations (4)

Hospital Israelita Albert Einstein; 🇧🇷 Sao Paulo, Brazil

IRCCS San Martino Policlinico Hospital; 🇮🇹 Genoa, Italy

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); 🇳🇱 Amsterdam, Netherlands

Hospital Clinic; 🇪🇸 Barcelona, Spain