Decision Support System to Evaluate VENTilation in ARDS

NCT04115709 | Completed DMC

• 1 other identifier: 19IC5421
• Study Type: interventional
• Target: 95
• Locations: 3 countries
• Sites: 3

Brief 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

Keywords

Acute Respiratory Distress Syndrome; Intensive Care; Device; Beacon Caresystem©; Ventilation

Outcome Measures

Primary Outcomes (1)

• Average Driving pressure delivery by the mechanical ventilator

  To assess the average driving pressure delivered by the mechanical ventilator over the period of time when ARDS ventilation management is advised by the Beacon Caresystem as compared to standard care.

  18 months

Secondary Outcomes (37)

• Daily Average physiological status - oxygenation (SpO2)

  18 months

• Daily Average physiological status - end-tidal CO2 fraction (FE'CO2)

  18 months

• Daily Average physiological status - metabolism (VO2, VCO2)

  18 months

• Daily Average physiological status - ventilation (respiratory rate)

  18 months

• Daily Average physiological status - ventilation (tidal volume)

  18 months

Study Arms (2)

Intervention: Device attached with advice activated

EXPERIMENTAL

Beacon Caresystem device will be attached to the patients and its ventilator advice will be activated.

Device: Beacon Caresystem device with advice

Control: standard care with device attached without advice

ACTIVE COMPARATOR

Beacon Caresystem device will be attached to the patients however the ventilator advice will be deactivated.

Device: Beacon Caresystem device without advice activated

Interventions

Beacon Caresystem device with advice DEVICE

Beacon Caresystem device provides ventilator settings advice to Doctors

Intervention: Device attached with advice activated

Beacon Caresystem device without advice activated DEVICE

Beacon Caresystem device does not give ventilator settings advice

Control: standard care with device attached without advice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Invasive mechanical ventilation.
• Within 1 week of a known clinical insult or new or worsening respiratory symptoms
• Chest radiograph with bilateral infiltrates consistent with evidence of pulmonary oedema but not fully explained by cardiac failure.
• Hypoxaemia as defined by PaO2/FiO2 of ≤ 300mmHg (or ≤ 40kPa) (pre-ECMO PaO2/FiO2 will be used should patient be placed on extracorporeal support).

You may not qualify if:

• Age \< 18 years old.
• The absence of an arterial catheter for blood sampling at study start.
• Consent declined.
• Over 7 days of mechanical ventilation.
• Treatment withdrawal imminent within 24 hours.
• DNAR (Do Not Attempt Resuscitation) order in place
• Severe chronic respiratory disease requiring domiciliary ventilation (except for sleep disordered breathing)
• Veno-Arterial ECMO
• Healthy Volunteer Sample collection:
• years or older
• Able to consent
• Have mental capacity
• Blood borne viruses: HIV, Hep B, Hep C
• Blood taken in the last 7 days
• Under doctor for investigation

Sponsors & Collaborators

• Imperial College London: lead
• European Commission: collaborator
• Mermaid A/C: collaborator
• Aalborg University: collaborator
• Université d'Auvergne: collaborator
• Medical University of Vienna: collaborator
• Sorbonne University: collaborator
• Queen's University, Belfast: collaborator

Study Sites (3)

Medical University of Vienna

Vienna, Waehringer Guertel, A-1090, Austria

Location

Université Clermont Auvergne

Clermont-Ferrand, 63003, France

Location

Imperial College London, Royal Brompton Hospital campus

London, SW3 6NP, United Kingdom

Location

Related Publications (2)

• Patel BV, Mumby S, Johnson N, Handslip R, Patel S, Lee T, Andersen MS, Falaschetti E, Adcock IM, McAuley DF, Takata M, Staudinger T, Karbing DS, Jabaudon M, Schellongowski P, Rees SE; DeVENT Study Group. A randomized control trial evaluating the advice of a physiological-model/digital twin-based decision support system on mechanical ventilation in patients with acute respiratory distress syndrome. Front Med (Lausanne). 2024 Oct 30;11:1473629. doi: 10.3389/fmed.2024.1473629. eCollection 2024.

  PMID: 39540041 DERIVED

• Patel B, Mumby S, Johnson N, Falaschetti E, Hansen J, Adcock I, McAuley D, Takata M, Karbing DS, Jabaudon M, Schellengowski P, Rees SE; DeVENT study group. Decision support system to evaluate ventilation in the acute respiratory distress syndrome (DeVENT study)-trial protocol. Trials. 2022 Jan 17;23(1):47. doi: 10.1186/s13063-021-05967-2.

  PMID: 35039050 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brijesh Patel, MBBS MRCP FRCA FFICM PhD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: October 4, 2019
• Study Start: March 19, 2020
• Primary Completion: March 30, 2021
• Study Completion: August 30, 2021
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); FR (1); GB (1)