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Associations of Intraoperative Hypocapnia With Patient Demographics, Ventilation Characteristics and Outcomes--Statistical Analysis Plan for an Individual Patient Data Analysis of PROVHILO and PROBESE
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).
Lung-protective intraoperative ventilation (LPV) has the potential to improve the outcome of surgery patients through a reduction in postoperative pulmonary complications. Use of intraoperative ventilation strategies that use a low tidal volume could result in intraoperative hypercapnia. However, hypocapnia remains surprisingly common during intraoperative ventilation, possibly meaning that anesthesiologists continue to use high, if not too high respiratory rates or tidal volumes. Previous studies suggested associations between intraoperative derangement of end-tidal carbon dioxide (etCO2) and postoperative outcomes. Indeed, two studies in highly selected patient groups showed associations of intraoperative hypocapnia with prolonged length of hospital stay, in patients undergoing pancreaticoduodenectomy, and in patients undergoing hysterectomy. 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; PROVHILO and PROBESE.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Hospital Israelita Albert Einstein
São Paulo, Brazil
University Hospital Carl Gustav Carus, Technische Universität Dresden
Dresden, Germany
IRCCS San Martino Policlinico Hospital
Genoa, Italy
Hospital Clinic de Barcelona
Barcelona, Spain
Start Date
November 29, 2022
Primary Completion Date
January 10, 2023
Completion Date
March 31, 2023
Last Updated
May 6, 2023
2,793
ACTUAL participants
intraoperative mechanical ventilation with hypocapnia (etCO2 < 35 mm Hg)
BEHAVIORAL
Lead Sponsor
NMC Specialty Hospital
Collaborators
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT04246463