title: Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery.
abstract: BACKGROUND
  Post-operative pulmonary complications add to the morbidity and mortality of surgical patients, in particular after general anesthesia >2 hours for abdominal surgery. Whether a protective mechanical ventilation strategy with higher levels of positive end-expiratory pressure (PEEP) and repeated recruitment maneuvers; the "open lung strategy", protects against post-operative pulmonary complications is uncertain. The present study aims at comparing a protective mechanical ventilation strategy with a conventional mechanical ventilation strategy during general anesthesia for abdominal non-laparoscopic surgery.
  
  
  METHODS
  The PROtective Ventilation using HIgh versus LOw positive end-expiratory pressure ("PROVHILO") trial is a worldwide investigator-initiated multicenter randomized controlled two-arm study. Nine hundred patients scheduled for non-laparoscopic abdominal surgery at high or intermediate risk for post-operative pulmonary complications are randomized to mechanical ventilation with the level of PEEP at 12 cmH(2)O with recruitment maneuvers (the lung-protective strategy) or mechanical ventilation with the level of PEEP at maximum 2 cmH(2)O without recruitment maneuvers (the conventional strategy). The primary endpoint is any post-operative pulmonary complication.
  
  
  CONCLUSIONS
  The PROVHILO trial is the first randomized controlled trial powered to investigate whether an open lung mechanical ventilation strategy in short-term mechanical ventilation prevents against postoperative pulmonary complications.
  
  
  BACKGROUND
  ISRCTN: ISRCTN70332574.
authors.affiliation: Department of Intensive Care Medicine & Laboratory of Experimental Intensive Care and Anesthesiology, Academic Medical Center, University of Amsterdam, The Netherlands. s.hemmes@amc.uva.nl
authors.forename: Sabrine N T
authors.initials: SN
authors.lastname: Hemmes
authors.forename: Paolo
authors.initials: P
authors.lastname: Severgnini
authors.forename: Samir
authors.initials: S
authors.lastname: Jaber
authors.forename: Jaume
authors.initials: J
authors.lastname: Canet
authors.forename: Hermann
authors.initials: H
authors.lastname: Wrigge
authors.forename: Michael
authors.initials: M
authors.lastname: Hiesmayr
authors.forename: Edda M
authors.initials: EM
authors.lastname: Tschernko
authors.forename: Markus W
authors.initials: MW
authors.lastname: Hollmann
authors.forename: Jan M
authors.initials: JM
authors.lastname: Binnekade
authors.forename: Göran
authors.initials: G
authors.lastname: Hedenstierna
authors.forename: Christian
authors.initials: C
authors.lastname: Putensen
authors.forename: Marcelo Gama
authors.initials: MG
authors.lastname: de Abreu
authors.forename: Paolo
authors.initials: P
authors.lastname: Pelosi
authors.forename: Marcus J
authors.initials: MJ
authors.lastname: Schultz
mesh_terms: D000005:Abdomen / Q000601:surgery*; D000768:Anesthesia, General / Q000009:adverse effects; D005060:Europe; D006801:Humans; D016015:Logistic Models; D008171:Lung Diseases / Q000209:etiology / Q000517:prevention & control*; D016017:Odds Ratio; D011175:Positive-Pressure Respiration / Q000009:adverse effects; D012107:Research Design; D018570:Risk Assessment; D012307:Risk Factors; D013514:Surgical Procedures, Operative / Q000009:adverse effects; D016896:Treatment Outcome