title: PReVENT--protective ventilation in patients without ARDS at start of ventilation: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  It is uncertain whether lung-protective mechanical ventilation using low tidal volumes should be used in all critically ill patients, irrespective of the presence of the acute respiratory distress syndrome (ARDS). A low tidal volume strategy includes use of higher respiratory rates, which could be associated with increased sedation needs, a higher incidence of delirium, and an increased risk of patient-ventilator asynchrony and ICU-acquired weakness. Another alleged side-effect of low tidal volume ventilation is the risk of atelectasis. All of these could offset the beneficial effects of low tidal volume ventilation as found in patients with ARDS.
  
  
  METHODS
  PReVENT is a national multicenter randomized controlled trial in invasively ventilated ICU patients without ARDS with an anticipated duration of ventilation of longer than 24 hours in 5 ICUs in The Netherlands. Consecutive patients are randomly assigned to a low tidal volume strategy using tidal volumes from 4 to 6 ml/kg predicted body weight (PBW) or a high tidal volume ventilation strategy using tidal volumes from 8 to 10 ml/kg PBW. The primary endpoint is the number of ventilator-free days and alive at day 28. Secondary endpoints include ICU and hospital length of stay (LOS), ICU and hospital mortality, the incidence of pulmonary complications, including ARDS, pneumonia, atelectasis, and pneumothorax, the cumulative use and duration of sedatives and neuromuscular blocking agents, incidence of ICU delirium, and the need for decreasing of instrumental dead space.
  
  
  CONCLUSIONS
  PReVENT is the first randomized controlled trial comparing a low tidal volume strategy with a high tidal volume strategy, in patients without ARDS at onset of ventilation, that recruits a sufficient number of patients to test the hypothesis that a low tidal volume strategy benefits patients without ARDS with regard to a clinically relevant endpoint.
  
  
  BACKGROUND
  The trial is registered at www.clinicaltrials.gov under reference number NCT02153294 on 23 May 2014.
authors.affiliation: Department of Intensive Care & Laboratory of Experimental Intensive Care and Anesthesiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands. f.d.simonis@amc.uva.nl.
authors.forename: Fabienne D
authors.initials: FD
authors.lastname: Simonis
authors.affiliation: Department of Intensive Care & Laboratory of Experimental Intensive Care and Anesthesiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands. j.m.binnekade@amc.uva.nl.
authors.forename: Jan M
authors.initials: JM
authors.lastname: Binnekade
authors.affiliation: Department of Intensive Care, Gelre Hospitals, Apeldoorn, The Netherlands. a.braber@gelre.nl.
authors.forename: Annemarije
authors.initials: A
authors.lastname: Braber
authors.affiliation: Department of Intensive Care & REVIVE Research VUmc Intensive Care, VU Medical Center, Amsterdam, The Netherlands. h.gelissen@vumc.nl.
authors.forename: Harry P
authors.initials: HP
authors.lastname: Gelissen
authors.affiliation: Department of Intensive Care, Tergooi, Hilversum, The Netherlands. jheidt@tergooi.nl.
authors.forename: Jeroen
authors.initials: J
authors.lastname: Heidt
authors.affiliation: Department of Intensive Care & Laboratory of Experimental Intensive Care and Anesthesiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands. j.horn@amc.uva.nl.
authors.forename: Janneke
authors.initials: J
authors.lastname: Horn
authors.affiliation: Department of Intensive Care, Tergooi, Hilversum, The Netherlands. ginnemee@tergooi.nl.
authors.forename: Gerard
authors.initials: G
authors.lastname: Innemee
authors.affiliation: Department of Intensive Care, Leiden University Medical Center, Leiden, The Netherlands. e.de_jonge@lumc.nl.
authors.forename: Evert
authors.initials: E
authors.lastname: de Jonge
authors.affiliation: Department of Intensive Care & Laboratory of Experimental Intensive Care and Anesthesiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands. n.p.juffermans@amc.uva.nl.
authors.forename: Nicole P
authors.initials: NP
authors.lastname: Juffermans
authors.affiliation: Department of Intensive Care, Gelre Hospitals, Apeldoorn, The Netherlands. p.spronk@gelre.nl.
authors.forename: Peter E
authors.initials: PE
authors.lastname: Spronk
authors.affiliation: Department of Health Technology and Services Research, Twente University, Enschede, The Netherlands. lotte.steuten@yahoo.com.
authors.forename: Lotte M
authors.initials: LM
authors.lastname: Steuten
authors.affiliation: Department of Intensive Care & REVIVE Research VUmc Intensive Care, VU Medical Center, Amsterdam, The Netherlands. p.tuinman@vumc.nl.
authors.forename: Pieter Roel
authors.initials: PR
authors.lastname: Tuinman
authors.affiliation: Department of Intensive Care, Tergooi, Hilversum, The Netherlands. marijnvriends@yahoo.com.
authors.forename: Marijn
authors.initials: M
authors.lastname: Vriends
authors.affiliation: Department of Intensive Care, Tergooi, Hilversum, The Netherlands. gdevreede@tergooi.nl.
authors.forename: Gwendolyn
authors.initials: G
authors.lastname: de Vreede
authors.affiliation: Department of Intensive Care, Leiden University Medical Center, Leiden, The Netherlands. r.b.p.de_wilde@lumc.nl.
authors.forename: Rob B
authors.initials: RB
authors.lastname: de Wilde
authors.affiliation: Department of Intensive Care & Laboratory of Experimental Intensive Care and Anesthesiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands. aryserpa@terra.com.br.|Department of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil. aryserpa@terra.com.br.
authors.forename: Ary
authors.initials: A
authors.lastname: Serpa Neto
authors.affiliation: Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus, Dresden, Germany. mgabreu@uniklinikum-dresden.de.
authors.forename: Marcelo
authors.initials: M
authors.lastname: Gama de Abreu
authors.affiliation: Department of Surgical Sciences and Integrated Diagnostics, IRCCS San Martino IST, University of Genoa, Genoa, Italy. ppelosi@hotmail.com.
authors.forename: Paolo
authors.initials: P
authors.lastname: Pelosi
authors.affiliation: Department of Intensive Care & Laboratory of Experimental Intensive Care and Anesthesiology, Academic Medical Center, University of Amsterdam, Meibergdreef 9, 1105, AZ, Amsterdam, The Netherlands. marcus.j.schultz@gmail.com.
authors.forename: Marcus J
authors.initials: MJ
authors.lastname: Schultz
mesh_terms: D002985:Clinical Protocols; D003422:Critical Care / Q000379:methods*; D016638:Critical Illness; D017052:Hospital Mortality; D006801:Humans; D007362:Intensive Care Units; D007902:Length of Stay; D008168:Lung / Q000503:physiopathology*; D009426:Netherlands; D018579:Patient Selection; D012107:Research Design; D012121:Respiration, Artificial / Q000009:adverse effects / Q000379:methods* / Q000401:mortality; D012128:Respiratory Distress Syndrome / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D012307:Risk Factors; D013990:Tidal Volume; D013997:Time Factors; D016896:Treatment Outcome; D015300:Ventilator Weaning; D055397:Ventilator-Induced Lung Injury / Q000175:diagnosis / Q000401:mortality / Q000503:physiopathology / Q000517:prevention & control*