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Open Access 01-12-2022 | Care | Study protocol

Decision support system to evaluate ventilation in the acute respiratory distress syndrome (DeVENT study)—trial protocol

Authors: Brijesh Patel, Sharon Mumby, Nicholas Johnson, Emanuela Falaschetti, Jorgen Hansen, Ian Adcock, Danny McAuley, Masao Takata, Dan S. Karbing, Matthieu Jabaudon, Peter Schellengowski, Stephen E. Rees, on behalf of the DeVENT study group

Published in: Trials | Issue 1/2022

Abstract

Background

The acute respiratory distress syndrome (ARDS) occurs in response to a variety of insults, and mechanical ventilation is life-saving in this setting, but ventilator-induced lung injury can also contribute to the morbidity and mortality in the condition. The Beacon Caresystem is a model-based bedside decision support system using mathematical models tuned to the individual patient’s physiology to advise on appropriate ventilator settings. Personalised approaches using individual patient description may be particularly advantageous in complex patients, including those who are difficult to mechanically ventilate and wean, in particular ARDS.

Methods

We will conduct a multi-centre international randomised, controlled, allocation concealed, open, pragmatic clinical trial to compare mechanical ventilation in ARDS patients following application of the Beacon Caresystem to that of standard routine care to investigate whether use of the system results in a reduction in driving pressure across all severities and phases of ARDS.

Discussion

Despite 20 years of clinical trial data showing significant improvements in ARDS mortality through mitigation of ventilator-induced lung injury, there remains a gap in its personalised application at the bedside. Importantly, the protective effects of higher positive end-expiratory pressure (PEEP) were noted only when there were associated decreases in driving pressure. Hence, the pressures set on the ventilator should be determined by the diseased lungs’ pressure-volume relationship which is often unknown or difficult to determine. Knowledge of extent of recruitable lung could improve the ventilator driving pressure. Hence, personalised management demands the application of mechanical ventilation according to the physiological state of the diseased lung at that time. Hence, there is significant rationale for the development of point-of-care clinical decision support systems which help personalise ventilatory strategy according to the current physiology. Furthermore, the potential for the application of the Beacon Caresystem to facilitate local and remote management of large numbers of ventilated patients (as seen during this COVID-19 pandemic) could change the outcome of mechanically ventilated patients during the course of this and future pandemics.

Trial registration

ClinicalTrials.gov identifier NCT04115709. Registered on 4 October 2019, version 4.0

Available only for authorised users

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Title: Decision support system to evaluate ventilation in the acute respiratory distress syndrome (DeVENT study)—trial protocol
Authors: Brijesh Patel
Sharon Mumby
Nicholas Johnson
Emanuela Falaschetti
Jorgen Hansen
Ian Adcock
Danny McAuley
Masao Takata
Dan S. Karbing
Matthieu Jabaudon
Peter Schellengowski
Stephen E. Rees
on behalf of the DeVENT study group
Publication date: 01-12-2022
Publisher: BioMed Central
Keywords: Care
Acute Respiratory Distress-Syndrome
COVID-19
ECMO
ECMO
Published in: Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-021-05967-2

2024 ASCO Annual Meeting

Springer Medicine

Decision support system to evaluate ventilation in the acute respiratory distress syndrome (DeVENT study)—trial protocol

Abstract

Background

Methods

Discussion

Trial registration

2024 ASCO Annual Meeting

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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