TY - JOUR
T1 - PReVENT--protective ventilation in patients without ARDS at start of ventilation: study protocol for a randomized controlled trial
AU - Simonis, Fabienne D.
AU - Binnekade, Jan M.
AU - Braber, Annemarije
AU - Gelissen, Harry P.
AU - Heidt, Jeroen
AU - Horn, Janneke
AU - Innemee, Gerard
AU - de Jonge, Evert
AU - Juffermans, Nicole P.
AU - Spronk, Peter E.
AU - Steuten, Lotte M.
AU - Tuinman, Pieter Roel
AU - Vriends, Marijn
AU - de Vreede, Gwendolyn
AU - de Wilde, Rob B.
AU - Serpa Neto, Ary
AU - Gama de Abreu, Marcelo
AU - Pelosi, Paolo
AU - Schultz, Marcus J.
AU - Gelissen, HP
PY - 2015
Y1 - 2015
N2 - 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. 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. 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. The trial is registered at www.clinicaltrials.gov under reference number NCT02153294 on 23 May 2014
AB - 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. 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. 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. The trial is registered at www.clinicaltrials.gov under reference number NCT02153294 on 23 May 2014
U2 - https://doi.org/10.1186/s13063-015-0759-1
DO - https://doi.org/10.1186/s13063-015-0759-1
M3 - Article
C2 - 26003545
SN - 1745-6215
VL - 16
SP - 226
JO - Trials
JF - Trials
IS - 1
M1 - 226
ER -