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.
Study Type
OBSERVATIONAL
Enrollment
3,837
Use of high levels of PEEP combined with recruitment maneuvers and low tidal volume ventilation during general anesthesia
Use of low levels of PEEP without recruitment maneuvers and low tidal volume ventilation during general anesthesia
University Hospital Carl Gustav Carus, Technische Universität Dresden
Dresden, Germany
Amsterdam UMC, University of Amsterdam
Amsterdam, Netherlands
Hospital Clinico Universitario de Valencia
Valencia, Spain
Incidence of postoperative pulmonary complications
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.
Time frame: Until day seven or hospital discharge, whichever comes first
Incidence of severe postoperative pulmonary complications
Collapsed composite of complications developing within the first seven postoperative days, including: Severe respiratory failure; or Acute Respiratory Distress Syndrome (ARDS); or Pulmonary infection; or Pleural effusion; or Atelectasis; or Pneumothorax; or Bronchospasm
Time frame: Until day seven or hospital discharge, whichever comes first
Incidence of extrapulmonary pulmonary complications
Collapsed composite of complications developing within the first seven postoperative days, including: Systemic Response Inflammatory Syndrome; or Sepsis; or Septic Shock; or Acute Kidney Injury.
Time frame: Until day seven or hospital discharge, whichever comes first
Incidence of intraoperative complications
Defined as intraoperative hypotension; or need for rescue for desaturations; or need for vasoactive drugs.
Time frame: Intraoperatively
Incidence of intensive care unit admission
Incidence of intensive care unit admission during hospital stay
Time frame: Until hospital discharge, death or 100 days, whichever comes first
Hospital length of stay
Duration of hospital length of stay in days
Time frame: Until hospital discharge, death or 100 days, whichever comes first
Incidence of 7-day mortality
Mortality during the first seven days of hospitalization
Time frame: Until day seven or hospital discharge, whichever comes first
Incidence of in-hospital mortality
Mortality during hospitalization
Time frame: Until hospital discharge, death or 100 days, whichever comes first
Incidence of major postoperative complications
Collapsed composite of complications developing within the first seven postoperative combining severe postoperative pulmonary complications, sepsis, septic shock and/or acute kidney injury)
Time frame: Until day seven or hospital discharge, whichever comes first
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