a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation

NCT05886387 | Completed

• 1 other identifier: Bayes_Repeat
• Study Type: observational
• Target: 3,836
• Locations: 4 countries
• Sites: 4

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.

Conditions

Mechanical Ventilation Complication; Surgery; Pulmonary Complication; Postoperative Complications

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative pulmonary complications

  Until day seven or hospital discharge, whichever comes first ]

Study Arms (2)

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

Standard PEEP

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

Other: Standard PEEP. Low positive end-expriatory pressure

Interventions

High PEEP + Recruitment maneuvers OTHER

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

High PEEP + Recruitment Maneuvers

Standard PEEP. Low positive end-expriatory pressure OTHER

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

Standard PEEP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients undergoing mechanical ventilation for general anesthesia for surgery.

You may qualify if:

• Planned for major surgery
• At risk for pulmonary complications

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (4)

Hospital Israelita Albert Einstein

São Paulo, Brazil

Location

IRCCS San Martino Policlinico Hospital

Genoa, Italy

Location

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Amsterdam, Netherlands

Location

Hospital Clinic

Barcelona, Spain

Location

Related 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

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2023
• First Posted: June 2, 2023
• Study Start: September 22, 2022
• Primary Completion: December 10, 2023
• Study Completion: December 25, 2023
• Last Updated: October 9, 2024

Record last verified: 2024-10

Locations

BR (1); IT (1); ES (1); NL (1)