CompletedNot Applicable

Intraoperative Hypocapnia in PROVHILO and PROBESE

Brazil, Germany, Italy2,793 participantsStarted 2022-11-29

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Planned for major (abdominal) surgery. * At risk for postoperative pulmonary complications. Exclusion Criteria: * Planned thoracic surgery or neurosurgery. * Unscheduled surgery (i.e., urgent, or emergent surgeries) were excluded because these patients may have had metabolic abnormalities at the moment of surgery, i.e., metabolic acidosis, for which the anesthesiologist may have adjusted the intraoperative ventilator settings. This may have led to a 'compensatory' low etCO2. * Patients with etCO2 recordings are missing from the study databases.

What they're measuring

Incidence of postoperative pulmonary complications

Timeframe: Until day seven or hospital discharge, whichever comes first

Trial details

NCT IDNCT05550181

SponsorNMC Specialty Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-01-10

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