Clinical trial NCT05886387: a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation Complication
Surgery
Pulmonary Complication
Postoperative Complications
Keywords: Mechanical ventilation,
Bayesian analysis
PEEP
Recruitment Maneuvers
Intraoperative Mechanical Ventilation
Postoperative complications
Perioperative medicine
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Hospital Israelita Albert Einstein
name: University Hospital Carl Gustav Carus
name: Hospital Clínico Universitario de Valencia
First posted: 2023-06-02
Enrollment: 3836
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing mechanical ventilation for general anesthesia for surgery.

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.

Eligibility criteria: Inclusion Criteria:

* Planned for major surgery
* At risk for pulmonary complications

Exclusion Criteria:

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

Primary outcomes:
measure: Incidence of postoperative pulmonary complications
timeFrame: Until day seven or hospital discharge, whichever comes first ]
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
city: Genoa
country: Italy
facility: IRCCS San Martino Policlinico Hospital
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
city: Barcelona
country: Spain
facility: Hospital Clinic
Study officials:
References: