Re-Evaluation of the Effects of High PEEP During General Anesthesia For Surgery - An Individual Patient Data Meta-Analysis of PROVHILO, iPROVE and PROBESE
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Surgery
- Sponsor
- Hospital Israelita Albert Einstein
- Enrollment
- 3837
- Locations
- 3
- Primary Endpoint
- Incidence of postoperative pulmonary complications
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Aiming to understand the isolated impact of high PEEP in patients undergoing mechanical ventilation for general anesthesia for surgery, three appropriately sized international multicentre randomized controlled trials have been performed over recent years: the 'PROtective Ventilation using HIgh versus LOw PEEP trial (PROVHILO), the 'individualized PeRioperative Open-lung Ventilation trial' (iPROVE), and the 'Protective intraoperative ventilation with higher versus lower levels of positive end-expiratory pressure in obese patients trial' (PROBESE). These three trials had several similarities in key areas of their study protocols, inclusion and exclusion criteria, and collected data, and even the primary and secondary outcomes. Of note, the three trials combined high PEEP with recruitment manoeuvres. This allows an individual patient data meta-analysis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Enrolled into one of the three studies (PROVHILO, iPROVE or PROBESE) to either high PEEP or low PEEP
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of postoperative pulmonary complications
Time Frame: Until day seven or hospital discharge, whichever comes first
Collapsed composite of complications developing within the first seven postoperative days, including: Mild respiratory failure; or Severe respiratory failure; or Acute Respiratory Distress Syndrome (ARDS); or Pulmonary infection; or Pleural effusion; or Atelectasis; or Pneumothorax; or Bronchospasm.
Secondary Outcomes
- Incidence of extrapulmonary pulmonary complications(Until day seven or hospital discharge, whichever comes first)
- Incidence of intraoperative complications(Intraoperatively)
- Incidence of severe postoperative pulmonary complications(Until day seven or hospital discharge, whichever comes first)
- Incidence of intensive care unit admission(Until hospital discharge, death or 100 days, whichever comes first)
- Hospital length of stay(Until hospital discharge, death or 100 days, whichever comes first)
- Incidence of 7-day mortality(Until day seven or hospital discharge, whichever comes first)
- Incidence of in-hospital mortality(Until hospital discharge, death or 100 days, whichever comes first)
- Incidence of major postoperative complications(Until day seven or hospital discharge, whichever comes first)