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Decision support system to evaluate ventilation in the acute respiratory distress syndrome (DeVENT study)-trial protocol.
Patel, Brijesh; Mumby, Sharon; Johnson, Nicholas; Falaschetti, Emanuela; Hansen, Jorgen; Adcock, Ian; McAuley, Danny; Takata, Masao; Karbing, Dan S; Jabaudon, Matthieu; Schellengowski, Peter; Rees, Stephen E.
  • Patel B; Division of Anaesthetics, Pain Medicine, and Intensive Care, Department of Surgery and Cancer, Imperial College, London, UK. brijesh.patel@imperial.ac.uk.
  • Mumby S; Airway Disease, National, Heart & Lung Institute, Imperial College, London, UK.
  • Johnson N; Imperial Clinical Trials Unit, Stadium House, 68 Wood Lane, London, W12 7RH, UK.
  • Falaschetti E; Imperial Clinical Trials Unit, Stadium House, 68 Wood Lane, London, W12 7RH, UK.
  • Hansen J; Mermaid Care A/S, Aalborg, Denmark.
  • Adcock I; Airway Disease, National, Heart & Lung Institute, Imperial College, London, UK.
  • McAuley D; Wellcome-Wolfson Institute for Experimental Medicine, Queen's University, Belfast, UK.
  • Takata M; Division of Anaesthetics, Pain Medicine, and Intensive Care, Department of Surgery and Cancer, Imperial College, London, UK.
  • Karbing DS; Respiratory and Critical Care Group, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.
  • Jabaudon M; Department of Perioperative Medicine, University Hospital of Clermont-Ferrand, GReD, Université Clermont Auvergne, CNRS, INSERM, Clermont-Ferrand, France.
  • Schellengowski P; Medical University of Vienna, Department of Medicine I, Waehringer Guertel 18-20, A-1090, Vienna, Austria.
  • Rees SE; Respiratory and Critical Care Group, Department of Health Science and Technology, Aalborg University, Aalborg, Denmark.
Trials ; 23(1): 47, 2022 Jan 17.
Article in English | MEDLINE | ID: covidwho-1628973
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Distress Syndrome / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2022 Document Type: Article Affiliation country: S13063-021-05967-2

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Respiratory Distress Syndrome / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study / Randomized controlled trials Limits: Humans Language: English Journal: Trials Journal subject: Medicine / Therapeutics Year: 2022 Document Type: Article Affiliation country: S13063-021-05967-2