Low vs Intermediate Tidal Volume Strategy in ICU Patients Without ARDS
PReVENT trial design and results
Design
Multicentre randomised clinical trial
Treatment
Low tidal volume strategy
Control
Intermediate tidal volume strategy
Population
961 intensive care patients without ARDS, 65% male, median age 68
Follow-up
90 days
Primary endpoint
Ventilator-free days and alive at day 28
Result
Median ventilator-free days 21 (IQR 0 to 26) in both groups — mean difference -0.27 (95% CI -1.74 to 1.19, p=0.71). No difference in ICU stay (6 vs 6 days), hospital stay (14 vs 15 days), 28-day mortality (34.9% vs 32.1%, HR 1.12) or 90-day mortality (39.1% vs 37.8%, HR 1.07).
Secondary endpoints
ICU and hospital length of stay, 28-day and 90-day mortality, development of ARDS
In patients in the ICU without ARDS who were expected not to be extubated within 24 hours of randomization, a low tidal volume strategy did not result in a greater number of ventilator-free days than an intermediate tidal volume strategy.
The trial authors, in the published abstract
How it has aged
Marks the boundary of the ARMA result. Lung-protective ventilation transformed outcomes in ARDS and does nothing measurable in patients without it — a useful corrective to the assumption that 6 mL/kg is universally protective.
Publications
Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without ARDS: A Randomized Clinical Trial
Simonis FD, Serpa Neto A, Binnekade JM, 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.