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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05886387
Enrollment
3836
Registered
2023-06-02
Start date
2022-09-22
Completion date
2023-12-25
Last updated
2024-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mechanical Ventilation Complication, Postoperative Complications, Pulmonary Complication, Surgery

Keywords

Mechanical ventilation,, Bayesian analysis, PEEP, Recruitment Maneuvers, Intraoperative Mechanical Ventilation, Postoperative complications, Perioperative medicine

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.

Interventions

OTHERHigh 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

OTHERStandard PEEP. Low positive end-expriatory pressure

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

Sponsors

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
CollaboratorOTHER
Hospital Israelita Albert Einstein
CollaboratorOTHER
University Hospital Carl Gustav Carus
CollaboratorOTHER
Hospital Clínico Universitario de Valencia
CollaboratorOTHER
Instituto de Investigacion Sanitaria La Fe
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Planned for major surgery * At risk for pulmonary complications

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Incidence of postoperative pulmonary complicationsUntil day seven or hospital discharge, whichever comes first ]

Countries

Brazil, Italy, Netherlands, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026