![]() Design, Setting, and Participants: A randomized clinical trial, conducted from September 1, 2014, through August 20, 2017, including patients without ARDS expected to not be extubated within 24 hours after start of ventilation from 6 intensive care units in the Netherlands. Objective: To determine whether a low tidal volume ventilation strategy is more effective than an intermediate tidal volume strategy. Trial Registration: Identifier: NCT02153294.Ībstract = "Importance: It remains uncertain whether invasive ventilation should use low tidal volumes in critically ill patients without acute respiratory distress syndrome (ARDS). Conclusions and Relevance: 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. There was no significant difference in the percentage of patients developing the following adverse events: ARDS (3.8% vs 5.0% risk ratio, 0.86 P =.38), pneumonia (4.2% vs 3.7% RR, 1.07 P =.67), severe atelectasis (11.4% vs 11.2% RR, 1.00 P =.94), and pneumothorax (1.8% vs 1.3% RR, 1.16 P =.55). At day 28, 475 patients in the low tidal volume group had a median of 21 ventilator-free days (IQR, 0-26), and 480 patients in the intermediate tidal volume group had a median of 21 ventilator-free days (IQR, 0-26) (mean difference, -0.27 P =.71). Results: In total, 961 patients (65% male), with a median age of 68 years (interquartile range, 59-76), were enrolled. Secondary outcomes included length of ICU and hospital stay ICU, hospital, and 28- and 90-day mortality and development of ARDS, pneumonia, severe atelectasis, or pneumothorax. Main Outcomes and Measures: The primary outcome was the number of ventilator-free days and alive at day 28. Interventions: Invasive ventilation using low tidal volumes (n = 477) or intermediate tidal volumes (n = 484). ![]() ![]() Importance: It remains uncertain whether invasive ventilation should use low tidal volumes in critically ill patients without acute respiratory distress syndrome (ARDS).
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