Decision Support System to Evaluate VENTilation in ARDS

Summary

Patients with Acute Respiratory Distress Syndrome (ARDS) residing in the intensive care unit (ICU) often require support for their breathing from a mechanical ventilator to provide adequate gas exchange, and although it is life-saving in this setting, it is also known to contribute to the morbidity and mortality in the condition.

Mechanical ventilation delivers a volume and pressure of gas for each breath and can vary oxygen levels. Selecting the correct oxygen, pressure and volume levels is important, as incorrect levels can harm the patient, and result in an increased time connected to the ventilator.

Recently, a system has been developed (the Beacon Caresystem) which advises the healthcare practitioner by the bedside as to how to best set the ventilator. This system is based on mathematics which describes the patients disease and may therefore provide ventilator settings which better suit the individual.

The purpose of this study is to compare mechanical ventilation in ARDS patients following advice from the Beacon Caresystem to that of standard care to investigate whether the use of the system results in improved ventilation in all severities and phases of ARDS and thus reducing morbidity in ARDS. The investigators plan to recruit 110 patients (50 in the UK and 30 in each of the other 2 sites). The study also aims to examine the biological and physiological factors that determine the worsening of ARDS and the processes involved in recovery from ARDS with the aim to develop new therapies to help detect the condition and improve recovery.

The investigators will utilise all raw data will be collected from the Beacon Caresystem to physiologically characterise the progression and resolution phases of ARDS.

Additionally blood and Urine samples will be taken from healthy volunteers (100 in total) as a control comparison group for the biological analyses carried out in the DeVENT study.

Conditions

• Acute Respiratory Distress Syndrome

Interventions

DEVICE

Beacon Caresystem device with advice

Beacon Caresystem device provides ventilator settings advice to Doctors

DEVICE

Beacon Caresystem device without advice activated

Beacon Caresystem device does not give ventilator settings advice

Sponsors & Collaborators

• European Commission

  collaborator OTHER

• Mermaid A/C

  collaborator UNKNOWN

• Aalborg University

  collaborator OTHER

• Université d'Auvergne

  collaborator OTHER

• Medical University of Vienna

  collaborator OTHER

• Sorbonne University

  collaborator OTHER

• Queen's University, Belfast

  collaborator OTHER

• Imperial College London

  lead OTHER

Principal Investigators

• Brijesh Patel, MBBS MRCP FRCA FFICM PhD · Imperial College London

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-03-19

Primary Completion

2021-03-30

Completion

2021-08-30

Countries

• Austria
• France
• United Kingdom

Study Locations