Clinical trial NCT05550181: Intraoperative Hypocapnia in PROVHILO and PROBESE
Official title: Associations of Intraoperative Hypocapnia With Patient Demographics, Ventilation Characteristics and Outcomes--Statistical Analysis Plan for an Individual Patient Data Analysis of PROVHILO and PROBESE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mechanical Ventilation Complication
Surgery
Pulmonary Complication
Intraoperative Complications
Postoperative Complications
Keywords: Postoperative Complications
Intraoperative Complications
Hypocapnia
Mechanical Ventilation
Lead sponsor: NMC Specialty Hospital
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Hospital Israelita Albert Einstein
name: University Hospital Carl Gustav Carus
name: Hospital Clínico Universitario de Valencia
First posted: 2022-09-22
Enrollment: 2793
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients undergoing mechanical ventilation for general anesthesia for surgery.

Brief 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of postoperative pulmonary complications
timeFrame: Until day seven or hospital discharge, whichever comes first
Secondary outcomes:
measure: Incidence of intraoperative complications
timeFrame: Intraoperatively
measure: Incidence of intensive care unit admission
timeFrame: Until hospital discharge, death or 100 days, whichever comes first
measure: Incidence of extrapulmonary pulmonary complications
timeFrame: Until day seven or hospital discharge, whichever comes first
measure: Incidence of 7-day mortality
timeFrame: Mortality during the first seven days of hospitalization
measure: Incidence of in-hospital mortality
timeFrame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 days
measure: Incidence of major postoperative complications
timeFrame: Until day seven or hospital discharge, whichever comes first
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus, Technische Universität Dresden
city: Genoa
country: Italy
facility: IRCCS San Martino Policlinico Hospital
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Sabrine NT Hemmes, PhD
role: STUDY_CHAIR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: David MP van Meenen, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Frederique Paulus, PhD
role: STUDY_CHAIR
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Marcus J Schultz, PhD
role: STUDY_DIRECTOR
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