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

Issued Date

2018-11-13

Resource Type

Article

ISSN

15383598
00987484

DOI

10.1001/jama.2018.14280

Other identifier(s)

2-s2.0-85055590193

Rights

Mahidol University

Rights Holder(s)

SCOPUS

Bibliographic Citation

JAMA - Journal of the American Medical Association. Vol.320, No.18 (2018), 1872-1880

Suggested Citation

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 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 - Journal of the American Medical Association. Vol.320, No.18 (2018), 1872-1880. doi:10.1001/jama.2018.14280 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/46187

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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

Author(s)

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

Other Contributor(s)

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

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: ClinicalTrials.gov Identifier: NCT02153294.

Keyword(s)

Medicine

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URI

https://repository.li.mahidol.ac.th/handle/20.500.14594/46187

Collections

Scopus 2018