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Trials
Published in: Trials 1/2015

Open Access 01-12-2015 | Study protocol

PReVENT - protective ventilation in patients without ARDS at start of ventilation: study protocol for a randomized controlled trial

Authors: Fabienne D. Simonis, Jan M. Binnekade, Annemarije Braber, Harry P. Gelissen, Jeroen Heidt, Janneke Horn, Gerard Innemee, Evert de Jonge, Nicole P. Juffermans, Peter E. Spronk, Lotte M. Steuten, Pieter Roel Tuinman, Marijn Vriends, Gwendolyn de Vreede, Rob B. de Wilde, Ary Serpa Neto, Marcelo Gama de Abreu, Paolo Pelosi, Marcus J. Schultz

Published in: Trials | Issue 1/2015

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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/Design

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.

Discussion

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.

Trial registration

The trial is registered at www.​clinicaltrials.​gov under reference number NCT02153294 on 23 May 2014.
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Metadata
Title
PReVENT - protective ventilation in patients without ARDS at start of ventilation: study protocol for a randomized controlled trial
Authors
Fabienne D. Simonis
Jan M. Binnekade
Annemarije Braber
Harry P. Gelissen
Jeroen Heidt
Janneke Horn
Gerard Innemee
Evert de Jonge
Nicole P. Juffermans
Peter E. Spronk
Lotte M. Steuten
Pieter Roel Tuinman
Marijn Vriends
Gwendolyn de Vreede
Rob B. de Wilde
Ary Serpa Neto
Marcelo Gama de Abreu
Paolo Pelosi
Marcus J. Schultz
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Trials / Issue 1/2015
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-015-0759-1

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