At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Associations of Intraoperative Hypocapnia With Patient Demographics, Ventilation Characteristics and Outcomes--Statistical Analysis Plan for an Individual Patient Data Analysis of PROVHILO and PROBESE
In Brief
An observational study evaluating intraoperative mechanical ventilation with hypocapnia (etCO2 < 35 mm Hg) for Mechanical Ventilation Complication and 4 related conditions. Completed, enrolled 2,793 participants across 4 sites in 4 countries.
Detailed 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).
Study Details
Timeline
Interventions
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.