a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3836 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-22

Study Completion Date

2023-12-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Re-Evaluation of the Effects of High PEEP During General Anesthesia For Surgery (REPEAT)

NCT03937375

Surgery Mechanical Ventilation Complication Pulmonary Complication

COMPLETED

Optimising Ventilatory Strategies by Using Positive Respiratory Integer Measurements

NCT06298435

Hypoxemia Hypercapnia Ventilator Associated Pneumonia +2 more

NOT_YET_RECRUITING

Effect of Recruitment Maneuvers Plus Optimal PEEP Versus Optimal PEEP Alone in One Lung Ventilation

NCT03635281

Mechanical Ventilation Complication

COMPLETED NA

Comparison of Hemodynamic Effect of 2 Methods for Alveolar Recruitment Maneuver in Anesthetized Patients

NCT03215329

Stroke Volume Variation Arterial Pressure

UNKNOWN

Physiological Effects of Lung Recruitment During General Anesthesia and Low-tidal Volume Ventilation

NCT03083457

Anesthesia, General Surgery

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mechanical Ventilation Complication Surgery Pulmonary Complication Postoperative Complications

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High PEEP + Recruitment Maneuvers

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

High PEEP + Recruitment maneuvers

Intervention Type OTHER

The use of a High PEEP (positive end-expiratory pressure) level after recruiting collapsed alveoli can protect from mechanical ventilation associated lung injury

Standard PEEP

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

Standard PEEP. Low positive end-expriatory pressure

Intervention Type OTHER

Mechanical ventilation is managed with a low standard PEEP without recruitment manneuvers

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High PEEP + Recruitment maneuvers

The use of a High PEEP (positive end-expiratory pressure) level after recruiting collapsed alveoli can protect from mechanical ventilation associated lung injury

Intervention Type OTHER