Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without ARDS: A Randomized Clinical Trial

• Published in: JAMA : the journal of the American Medical Association Vol. 320; no. 18; pp. 1872 - 1880
• Main Authors: Simonis, Fabienne D, Serpa Neto, Ary, Binnekade, Jan M, Braber, Annemarije, Bruin, Karina C. M, Determann, Rogier M, Goekoop, Geert-Jan, Heidt, Jeroen, Horn, Janneke, Innemee, Gerard, de Jonge, Evert, Juffermans, Nicole P, Spronk, Peter E, Steuten, Lotte M, Tuinman, Pieter Roel, de Wilde, Rob B.P, Vriends, Marijn, Gama de Abreu, Marcelo, Pelosi, Paolo, Schultz, Marcus J
• Format: Journal Article
• Language: English
• Published: United States American Medical Association 13.11.2018
• Subjects: Aged; Atelectasis; Caring for the Critically Ill Patient; Clinical trials; Critical Illness - mortality; Critical Illness - therapy; Female; Hospital Mortality; Hospitals; Humans; Intensive care; Intensive Care Units; Male; Mechanical ventilation; Middle Aged; Mortality; Online First; Original Investigation; Outcome and Process Assessment (Health Care); Patients; Pneumonia; Pneumothorax; Respiration, Artificial - adverse effects; Respiration, Artificial - methods; Respiratory distress syndrome; Respiratory Distress Syndrome, Adult; Respiratory Insufficiency - physiopathology; Respiratory Insufficiency - therapy; Strategy; Tidal Volume; Ventilation; Ventilator Weaning; Ventilator-Induced Lung Injury; Ventilators; Volume
• ISSN: 0098-7484; 1538-3598
• DOI: 10.1001/jama.2018.14280

IMPORTANCE: It remains uncertain whether invasive ventilation should use low tidal volumes in critically ill patients without acute respiratory distress syndrome (ARDS). OBJECTIVE: To determine whether a low tidal volume ventilation strategy is more effective than an intermediate tidal volume strategy. 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. INTERVENTIONS: Invasive ventilation using low tidal volumes (n = 477) or intermediate tidal volumes (n = 484). MAIN OUTCOMES AND MEASURES: The primary outcome was the number of ventilator-free days and alive at day 28. 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. RESULTS: In total, 961 patients (65% male), with a median age of 68 years (interquartile range [IQR], 59-76), were enrolled. 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 [95% CI, –1.74 to 1.19]; P = .71). There was no significant difference in ICU (median, 6 vs 6 days; 0.39 [–1.09 to 1.89]; P = .58) and hospital (median, 14 vs 15 days; –0.60 [–3.52 to 2.31]; P = .68) length of stay or 28-day (34.9% vs 32.1%; hazard ratio [HR], 1.12 [0.90 to 1.40]; P = .30) and 90-day (39.1% vs 37.8%; HR, 1.07 [0.87 to 1.31]; P = .54) mortality. There was no significant difference in the percentage of patients developing the following adverse events: ARDS (3.8% vs 5.0%; risk ratio [RR], 0.86 [0.59 to 1.24]; P = .38), pneumonia (4.2% vs 3.7%; RR, 1.07 [0.78 to 1.47]; P = .67), severe atelectasis (11.4% vs 11.2%; RR, 1.00 [0.81 to 1.23]; P = .94), and pneumothorax (1.8% vs 1.3%; RR, 1.16 [0.73 to 1.84]; P = .55). 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02153294