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In patients in the intensive care unit (ICU) who received invasive ventilation for reasons other than acute respiratory distress syndrome (ARDS), is a ventilation strategy with low tidal volume more effective than a strategy using intermediate tidal volume with respect to the number of ventilator-free days and alive at day 28?
In this randomized clinical trial that included 961 patients in the ICU who were receiving invasive ventilation and expected to not be extubated within 24 hours of randomization, a ventilation strategy with low tidal volume did not result in a significant difference in ventilator-free days and alive at day 28 than a ventilation strategy with intermediate tidal volumes (median, 21 days vs 21 days).
Among patients in the ICU receiving invasive ventilation, a strategy with low tidal volume was not more effective than a strategy using intermediate tidal volume.
It remains uncertain whether invasive ventilation should use low tidal volumes in critically ill patients without acute respiratory distress syndrome (ARDS).
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.
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.
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.
ClinicalTrials.gov Identifier: NCT02153294
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Accepted for Publication: September 10, 2018.
Corresponding Author: Marcus J. Schultz, MD, PhD, Department of Intensive Care, C3-423, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam, the Netherlands (firstname.lastname@example.org).
Published Online: October 24, 2018. doi:10.1001/jama.2018.14280
Writing Group for the PReVENT Investigators: Fabienne D. Simonis, MD; Ary Serpa Neto, MD, MSc, PhD; Jan M. Binnekade, PhD; Annemarije Braber, MD; Karina C. M. Bruin; Rogier M. Determann, MD, PhD; Geert-Jan Goekoop, MD; Jeroen Heidt, MD; Janneke Horn, MD, PhD; Gerard Innemee, MD; Evert de Jonge, MD, PhD; Nicole P. Juffermans, MD, PhD; Peter E. Spronk, MD, PhD; Lotte M. Steuten, PhD, MSc; Pieter Roel Tuinman, MD, PhD; Rob B.P. de Wilde, PhD; Marijn Vriends; Marcelo Gama de Abreu, MD, PhD; Paolo Pelosi, MD, FERS; Marcus J. Schultz, MD, PhD.
Affiliations of Writing Group for the PReVENT Investigators: Department of Intensive Care & Laboratory of Experimental Intensive Care and Anesthesiology, Academic Medical Center, Amsterdam, the Netherlands (Simonis, Serpa Neto, Binnekade, Horn, Juffermans, Schultz); Department of Critical Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil (Serpa Neto); Department of Intensive Care, Gelre Hospitals, Apeldoorn, the Netherlands (Braber, Spronk); Department of Intensive Care, Westfriesgasthuis, Hoorn, the Netherlands (Bruin, Goekoop); Department of Intensive Care, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands (Determann); Department of Intensive Care Tergooi, Hilversum, the Netherlands (Heidt, Innemee); Department of Intensive Care, Leiden University Medical Center, Leiden, the Netherlands (de Jonge, de Wilde); Fred Hutchinson Cancer Research Center, Seattle, Washington (Steuten); Department of Intensive Care & REVIVE Research VUmc Intensive Care, VU Medical Center, Amsterdam, the Netherlands (Tuinman, Vriends); Department of Anesthesiology and Intensive Care, Pulmonary Engineering Group, University Hospital Carl Gustav Carus, Dresden, Germany (Gama de Abreu); Department of Surgical Sciences and Integrated Diagnostics, San Martino Policlinico Hospital, IRCCS for Oncology, University of Genoa, Genoa, Italy (Pelosi); Mahidol-Oxford Tropical Medicine Research Unit (MORU), Mahidol University, Bangkok, Thailand (Schultz).
Author Contributions: Drs Simonis and Serpa Neto had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. The writing group vouches for the accuracy and completeness of the data and for the fidelity of the study to the protocol.
Concept and design: Simonis, Serpa Neto, Binnekade, Horn, Innemee, Juffermans, Steuten, Tuinman, Gama de Abreu, Pelosi, Schultz.
Acquisition, analysis, or interpretation of data: Simonis, Serpa Neto, Braber, Bruin, Determann, Goekoop, Heidt, Horn, Innemee, Jonge, Spronk, Vriends, Wilde, Gama de Abreu, Pelosi, Schultz.
Drafting of the manuscript: Simonis, Serpa Neto, Gama de Abreu, Pelosi, Schultz.
Critical revision of the manuscript for important intellectual content: All authors.
Statistical analysis: Simonis, Serpa Neto, Binnekade, Gama de Abreu, Schultz.
Obtained funding: Schultz.
Administrative, technical, or material support: Simonis, Braber, Bruin, Determann, Goekoop, Heidt, Innemee, Jonge, Spronk, Tuinman, Wilde, Schultz.
Supervision: Serpa Neto, Horn, Jonge, Juffermans, Steuten, Wilde, Gama de Abreu, Pelosi, Schultz.
Other - coordination: Simonis.
Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Binnekade reports receiving grants from ZonMW. No other disclosures were reported.
Funding/Support: This study was supported by a grant from ZonMW, Netherlands Organization for Health Research and Development (http://www.zonmw.nl) and the Academic Medical Center (Amsterdam, the Netherlands).
Role of the Funder/Sponsor: The funding sources had no role in the conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 4.
Collaborators: A.L.I.P van der Veen (AMC); J. Wigbers (LUMC); A. Dalhuisen, J. Hofhuis, M. Jansen, M. Flim, M. ten Kleij (Gelre); Y.C. van Gendt, V. van Schaik, G. Klein–de Vreede (Tergooi); E. Alberts, H.P.P.M. Gelissen, MD (VUmc). The collaborators performed several trial activities, including randomization, supervision of protocol adherence in both groups and data collection.
Additional Contributions: We are indebted to all multidisciplinary teams in participant centers for their enthusiastic support and following the study interventions. We thank the PROtective VEntilation Network (http://www.provenet.eu) for support.
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