a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 3836

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil
    • Hospital Israelita Albert Einstein
• Italy
  • Genoa, Italy
    • IRCCS San Martino Policlinico Hospital
• Netherlands
  • Amsterdam, Netherlands
    • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Spain
  • Barcelona, Spain
    • Hospital Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing mechanical ventilation for general anesthesia for surgery.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
High PEEP + Recruitment Maneuvers; Patients who received intraoperatively high PEEP (10-12 cmH2O) after a recruitment maneuvers as per the original study protocol	Other: 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
Standard PEEP; Patients who received intraoperatively standard PEEP (0-5 cmH2O) without recruitment maneuvers	Other: Standard PEEP. Low positive end-expriatory pressure; Mechanical ventilation is managed with a low standard PEEP without recruitment manneuvers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of postoperative pulmonary complications	Until day seven or hospital discharge, whichever comes first ]

Collaborators and Investigators

• Sponsor: Instituto de Investigacion Sanitaria La Fe
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); Hospital Israelita Albert Einstein; University Hospital Carl Gustav Carus; Hospital Clínico Universitario de Valencia

Publications and helpful links

Helpful Links

• Association between ventilation parameter and postoperative complications
• PROBESE Study
• iPRVE study
• PROVHILO study
• The Association of Intraoperative driving pressure with postoperative pulmonary complications in open versus closed abdominal surgery patients

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2022
• Primary Completion (Actual): December 10, 2023
• Study Completion (Actual): December 25, 2023

Study Registration Dates

• First Submitted: May 23, 2023
• First Submitted That Met QC Criteria: May 23, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Estimated): October 9, 2024
• Last Update Submitted That Met QC Criteria: October 7, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Postoperative complications; PEEP; Bayesian analysis; Perioperative medicine; Mechanical ventilation,; Recruitment Maneuvers; Intraoperative Mechanical Ventilation
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications
• Other Study ID Numbers: Bayes_Repeat

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No