Protective Ventilation During General Anesthesia for Open Abdominal Surgery

A randomized controlled trial

PROVHILO, a randomized controlled trial, aims at comparing a lung–protective mechanical ventilation strategy (with the use of higher levels of PEEP and intra–operative Recruitment Maneuvers) with conventional mechanical ventilation (lower levels of PEEP without intra–operative Recruitment Maneuvers) during abdominal non–laparoscopic surgery in patients at high or intermediate risk for post–operative respiratory failure ( according to the ARISCAT risk score).
We hypothesize that a lung–protective mechanical ventilation strategy protects against post–operative pulmonary and extra–pulmonary complications, and shortens length of hospital stay.
Primary endpoint: postoperative pulmonary complications; secondary endpoints: intra–operative complications, need for ICU admission (if not as part of routine) or ICU readmission, hospital–free days at day 90, post–operative non–pulmonary organ function; post–operative wound healing; systemic levels of markers of pulmonary inflammation, and markers of distal organ injury.
PROVHILO was accepted for publication in The Lancet.

  • Chief Investigator: Prof. Dr. Marcus J. Schultz (AMC, University of Amsterdam)
  • Sponsor: ESA Clinical Trial Network
  • National Coordinator: Prof. Dr. S. De Hert
  • Investigator UZ Gent: Prof. Dr. L. De Baerdemaeker
  • Timeline: 3 years last inclusion on 14/01/2013