a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation

Surgery Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05886387
• Other study ID #: Bayes_Repeat
• Status: Active, not recruiting
• Start date: September 22, 2022
• Est. completion date: November 2023

Study information

• Verified date: May 2023
• Source: Instituto de Investigacion Sanitaria La Fe
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 3836
• Est. completion date: November 2023
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Planned for major surgery

• At risk for pulmonary complications

Exclusion Criteria:

• Planned thoracic surgery .

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

Related Conditions & MeSH terms

• Mechanical Ventilation Complication
• Postoperative Complications
• Pulmonary Complication
• Surgery

Intervention

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

Locations

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

Sponsors (5)

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

Countries where clinical trial is conducted

Brazil,  Italy,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of postoperative pulmonary complications		Until day seven or hospital discharge, whichever comes first ]

External Links

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