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Title: Effect of a Low vs Intermediate Tidal Volume Strategy on Ventilator-Free Days in Intensive Care Unit Patients Without ARDS: A Randomized Clinical Trial
Authors: Fabienne D. Simonis
Ary Serpa Neto
Jan M. Binnekade
Annemarije Braber
Karina C.M. Bruin
Rogier M. Determann
Geert Jan Goekoop
Jeroen Heidt
Janneke Horn
Gerard Innemee
Evert De Jonge
Nicole P. Juffermans
Peter E. Spronk
Lotte M. Steuten
Pieter Roel Tuinman
Rob B.P. De Wilde
Marijn Vriends
Marcelo Gama De Abreu
Paolo Pelosi
Marcus J. Schultz
Ospedale Policlinico San Martino
Gelre Ziekenhuizen
Dresden University Faculty of Medicine and University Hospital Carl Gustav Carus
Our Lady Hospital - Amsterdam
Hospital Israelita Albert Einstein
Leiden University Medical Center - LUMC
Mahidol University
Fred Hutchinson Cancer Research Center
Amsterdam UMC - Vrije Universiteit Amsterdam
Amsterdam UMC - University of Amsterdam
Keywords: Medicine
Issue Date: 13-Nov-2018
Citation: JAMA - Journal of the American Medical Association. Vol.320, No.18 (2018), 1872-1880
Abstract: © 2018 American Medical Association. All rights reserved. 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: Identifier: NCT02153294.
ISSN: 15383598
Appears in Collections:Scopus 2018

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