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Individual patient data analysis of tidal volumes used in three large randomized control trials involving patients with acute respiratory distress syndrome

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Poole, J., McDowell, C., Lall, Ranjit, Perkins, Gavin D., McAuley, D., Gao, F. and Young, D. (2017) Individual patient data analysis of tidal volumes used in three large randomized control trials involving patients with acute respiratory distress syndrome. British Journal of Anaesthesia, 118 (4). pp. 570-575. doi:10.1093/bja/aew465 ISSN 0007-0912.

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Official URL: http://dx.doi.org/10.1093/bja/aew465

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Abstract

Background. The acute respiratory distress syndrome (ARDS) is a condition with a high mortality and morbidity. Mechanical ventilation prevents immediate mortality but may further damage patients' lungs. Low tidal volume lung-protective strategies have been shown to increase survival by reducing this iatrogenic damage. Current guidelines recommend tidal volumes of 6-8 ml kg(-1) of predicted body weight. We used data from three large randomized controlled trials of treatments for ARDS to determine compliance with these recommendations.

Methods. We used the tidal volume recorded at randomization for all patients in the OSCAR, HARP-2, and BALTI-2 studies. In addition, we used the ventilation data for control arm patients in OSCAR and all patients in HARP-2 at days 1 and 7 after randomization.

Results. The three trials enrolled 1660 patients, with tidal volume data available at least at one time point in 1412 patients. Compliance with the 6-8 ml kg(-1) recommendation for tidal volume ranged from 20 to 39% of patients across all time points in all three trials.

Conclusion. Poor compliance with the guidelines for tidal volume in patients with ARDS has been demonstrated before in case series, but not in clinical trials where the patient population is specifically selected against standard ARDS diagnostic criteria and the investigators were encouraged to use low tidal volumes. This study may indicate a need to improve implementation and compliance with protective lung ventilation.

Item Type: Journal Article
Subjects: R Medicine > R Medicine (General)
Divisions: Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences
Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School
Journal or Publication Title: British Journal of Anaesthesia
Publisher: Oxford University Press
ISSN: 0007-0912
Official Date: April 2017
Dates:
DateEvent
April 2017Published
19 December 2016Accepted
Volume: 118
Number: 4
Page Range: pp. 570-575
DOI: 10.1093/bja/aew465
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access (Creative Commons)
Funder: National Institute for Health Research Health Technology Assessment (Great Britain) (NIHR HTA)

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