Journal Article

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

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

2015

Overview

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.

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V
• Subject: Acidosis / Acute respiratory distress syndrome / Anesthesia / Biomedicine / Care and treatment / Chronic obstructive pulmonary disease / Clinical Protocols / Complications and side effects / Consent / Critical Care - methods / Critical Illness / Delirium / Dyspnea / Emergency medical care / Health Sciences / Hospital Mortality / Hospital patients / Humans / Intensive Care Units / Length of Stay / Lung - physiopathology / Medicine / Medicine & Public Health / Mortality / Netherlands / Participation / Patient outcomes / Patient Selection / Patients / Prevention / Research Design / Respiration, Artificial - adverse effects / Respiration, Artificial - methods / Respiration, Artificial - mortality / Respiratory Distress Syndrome - diagnosis / Respiratory Distress Syndrome - mortality / Respiratory Distress Syndrome - physiopathology / Respiratory Distress Syndrome - therapy / Risk Factors / Statistics for Life Sciences / Study Protocol / Tidal Volume / Time Factors / Treatment Outcome / Ventilation / Ventilator Weaning / Ventilator-Induced Lung Injury - diagnosis / Ventilator-Induced Lung Injury - mortality / Ventilator-Induced Lung Injury - physiopathology / Ventilator-Induced Lung Injury - prevention & control / Ventilators