a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation

Instituto de Investigacion Sanitaria La Fe

Status: Completed

Conditions: Postoperative Complications; Mechanical Ventilation Complication; Surgery; Pulmonary Complication

Treatments: Other: Standard PEEP. Low positive end-expriatory pressure; Other: High PEEP + Recruitment maneuvers

Study type: Observational

Funder types: Other

Identifiers

NCT05886387

Bayes_Repeat

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,836 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Planned for major surgery
• At risk for pulmonary complications

Exclusion criteria

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

Trial design

3,836 participants in 2 patient groups

High PEEP + Recruitment Maneuvers

Description:

Patients who received intraoperatively high PEEP (10-12 cmH2O) after a recruitment maneuvers as per the original study protocol

Treatment:

Other: High PEEP + Recruitment maneuvers

Standard PEEP

Description:

Patients who received intraoperatively standard PEEP (0-5 cmH2O) without recruitment maneuvers

Treatment:

Other: Standard PEEP. Low positive end-expriatory pressure