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Intraoperative Hypocapnia in PROVHILO and PROBESE

NCT05550181 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2793

Last updated 2023-05-06

No results posted yet for this study

Summary

To gain a better understanding of the epidemiology of intraoperative hypocapnia, in particular the associations of intraoperative hypocapnia with patient demographics, ventilator characteristics, and perioperative complications we will perform an individual patient-level meta-analysis of two recent randomized clinical trials of intraoperative ventilation, the 'PROtective Ventilation using High versus LOw PEEP trial' (PROVHILO), and the 'Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients trial' (PROBESE).

Conditions

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

Interventions

BEHAVIORAL

intraoperative mechanical ventilation with hypocapnia (etCO2 < 35 mm Hg)

A patient is considered 'hypocapnic' if the etCO2 was \< 35 mm Hg at any point during surgery, from start of the study till end of the study and classified as 'without hypocapnia' otherwise. In case of a missing value immediately before extubation, we will use the values as reported in the last hour of surgery.

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

  • NMC Specialty Hospital

    lead OTHER

Principal Investigators

  • Sabrine NT Hemmes, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  • David MP van Meenen, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  • Frederique Paulus, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  • Marcus J Schultz, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-29
Primary Completion
2023-01-10
Completion
2023-03-31

Countries

  • Brazil
  • Germany
  • Italy
  • 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 NCT05550181 on ClinicalTrials.gov