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a Bayesian Analysis of Three Randomised Clinical Trials of Intraoperative Ventilation

NCT05886387 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3836

Last updated 2024-10-09

No results posted yet for this study

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

Interventions

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

OTHER

Standard PEEP. Low positive end-expriatory pressure

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

Sponsors & Collaborators

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

    collaborator OTHER

  • Hospital Israelita Albert Einstein

    collaborator OTHER

  • University Hospital Carl Gustav Carus

    collaborator OTHER

  • Hospital Clínico Universitario de Valencia

    collaborator OTHER

  • Instituto de Investigacion Sanitaria La Fe

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-22
Primary Completion
2023-12-10
Completion
2023-12-25

Countries

  • Brazil
  • Italy
  • Netherlands
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05886387 on ClinicalTrials.gov