PReVENT (acute respiratory distress syndrome)
Trial question
What is the effect of low tidal volume strategy in ICU patients without ARDS?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
35.0% female
65.0% male
N = 961
961 patients (340 female, 621 male).
Inclusion criteria: ICU patients without ARDS expected to not be extubated within 24 hours after start of ventilation.
Key exclusion criteria: presence of ARDS; ventilation lasting > 12 hours before admission to the ICU; uncontrollable ICP; pulmonary disease and new pulmonary thromboembolism.
Interventions
N=477 a low tidal volume ventilation strategy (at a tidal volume of 4-6 mL/kg predicted body weight).
N=484 an intermediate tidal volume ventilation strategy (at a tidal volume of 8-10 mL/kg predicted body weight).
Primary outcome
Ventilator-free days
21 days
21 days
21.0 days
15.8 days
10.5 days
5.3 days
0.0 days
A low tidal volume ventilation
strategy
An intermediate tidal volume ventilation
strategy
No significant
difference ↔
No significant difference in ventilator-free days (21 days vs. 21 days; AD -0.27 days, 95% CI -1.74 to 1.19).
Secondary outcomes
No significant difference in length of ICU stay (6 days vs. 6 days; AD 0.39 days, 95% CI -1.09 to 1.89).
No significant difference in length of hospital stay (14 days vs. 15 days; AD -0.6 days, 95% CI -3.52 to 2.31).
No significant difference in the rate of death by day 28 (34.9% vs. 32.1%; HR 1.12, 95% CI 0.9 to 1.4).
Safety outcomes
No significant differences in ARDS, pneumonia, severe atelectasis, pneumothorax, delirium, extrapulmonary infection and sepsis.
Conclusion
In ICU patients without ARDS expected to not be extubated within 24 hours after start of ventilation, a low tidal volume ventilation strategy was not superior to an intermediate tidal volume ventilation strategy with respect to a ventilator-free days.
Reference
Writing Group for the PReVENT Investigators, Fabienne D Simonis, Ary Serpa Neto et al. Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without ARDS: A Randomized Clinical Trial. JAMA. 2018 Nov 13;320(18):1872-1880.
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