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Decision Support System to Evaluate VENTilation in ARDS (DeVENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04115709
Recruitment Status : Completed
First Posted : October 4, 2019
Last Update Posted : September 16, 2021
Sponsor:
Collaborators:
European Commission
Mermaid A/C
Aalborg University
Université d'Auvergne
Medical University of Vienna
Sorbonne University
Queen's University, Belfast
Information provided by (Responsible Party):
Imperial College London

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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Device: Beacon Caresystem device with advice Device: Beacon Caresystem device without advice activated Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Decision Support System to Evaluate VENTilation in ARDS (DeVENT)
Actual Study Start Date : March 19, 2020
Actual Primary Completion Date : March 30, 2021
Actual Study Completion Date : August 30, 2021


Arm Intervention/treatment
Experimental: Intervention: Device attached with advice activated
Beacon Caresystem device will be attached to the patients and its ventilator advice will be activated.
Device: Beacon Caresystem device with advice
Beacon Caresystem device provides ventilator settings advice to Doctors

Active Comparator: Control: standard care with device attached without advice
Beacon Caresystem device will be attached to the patients however the ventilator advice will be deactivated.
Device: Beacon Caresystem device without advice activated
Beacon Caresystem device does not give ventilator settings advice




Primary Outcome Measures :
  1. Average Driving pressure delivery by the mechanical ventilator [ Time Frame: 18 months ]
    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.


Secondary Outcome Measures :
  1. Daily Average physiological status - oxygenation (SpO2) [ Time Frame: 18 months ]
    • Daily average physiological status defined as daily averages of measured values of oxygenation (SpO2)

  2. Daily Average physiological status - end-tidal CO2 fraction (FE'CO2) [ Time Frame: 18 months ]
    • Daily average physiological status defined as daily averages of measured values end-tidal CO2 fraction (FE'CO2)

  3. Daily Average physiological status - metabolism (VO2, VCO2) [ Time Frame: 18 months ]
    • Daily average physiological status defined as daily averages of measured values of metabolism (VO2, VCO2)

  4. Daily Average physiological status - ventilation (respiratory rate) [ Time Frame: 18 months ]
    • Daily average physiological status defined as daily averages of measured values of ventilation (respiratory rate)

  5. Daily Average physiological status - ventilation (tidal volume) [ Time Frame: 18 months ]
    • Daily average physiological status defined as daily averages of measured values of ventilation (tidal volume)

  6. Daily Average physiological status - ventilation (anatomical dead space) [ Time Frame: 18 months ]
    • Daily average physiological status defined as daily averages of measured values of ventilation (anatomical dead space)

  7. Daily Average physiological status - pulmonary mechanisms (mean airway pressure) [ Time Frame: 18 months ]
    • Daily average physiological status defined as daily averages of measured values of pulmonary mechanisms (mean airway pressure)

  8. Daily Average physiological status [ Time Frame: 18 months ]
    • Daily average physiological status defined as daily averages of measured values of pulmonary mechanisms (respiratory system compilance)

  9. Daily Average physiological status [ Time Frame: 18 months ]
    • Daily average physiological status defined as daily averages of measured values of ventilator settings

  10. Daily Average physiological status - PaO2/FiO2 [ Time Frame: 18 months ]
    • Daily average physiological status defined as daily averages of measured values of PaO2/FiO2

  11. Daily Average physiological status - shunt fraction [ Time Frame: 18 months ]
    • Daily average physiological status defined as daily averages of measured values of shunt fraction

  12. Daily Average physiological status - end-expiratory lung volume [ Time Frame: 18 months ]
    • Daily average physiological status defined as daily averages of measured values of end-expiratory lung volume over time as continuously measured by the Beacon system

  13. Daily average calculated delivered pressure over time [ Time Frame: 18 months ]
    • Daily average calculated delivered pressure over time, for periods of spontaneous breathing.

  14. Daily average calculated mechanical power over time [ Time Frame: 18 months ]
    • Daily average calculated mechanical power over time

  15. Daily average calculated oxygenation index over time [ Time Frame: 18 months ]
    • Daily average calculated oxygenation index over time

  16. Daily average ventilatory ratio over time [ Time Frame: 18 months ]
    • Daily average ventilatory ratio over time

  17. Incidence and duration of proning events and pre- and post- respiratory physiology [ Time Frame: 18 months ]
    • Incidence and duration of proning events and pre- and post- respiratory physiology

  18. Ventilator free days at 28 days. [ Time Frame: 28 days ]
    • Ventilator free days at 28 days.

  19. Composite endpoint including any cause of death at 28 days and days free of mechanical ventilation within 28 days among survivors [ Time Frame: 28 days ]
    • Composite endpoint including any cause of death at 28 days and days free of mechanical ventilation within 28 days among survivors

  20. Time from control mode to support mode [ Time Frame: 18 months ]
    • Time from control mode to support mode

  21. Proportion of breaths dysyncronous with the ventilator [ Time Frame: 18 months ]
    • Proportion of breaths dysyncronous with the ventilator

  22. Number of changes in ventilator settings per day [ Time Frame: 18 months ]
    • Number of changes in ventilator settings per day

  23. Percentage of time in control mode ventilation [ Time Frame: 18 months ]
    • % of time in control mode ventilation

  24. Percentage of time in support mode ventilation [ Time Frame: 18 months ]
    • % of time in support mode ventilation

  25. Total duration of mechanical ventilation [ Time Frame: 18 months ]
    • Total duration of mechanical ventilation

  26. Changes in tidal volume over time [ Time Frame: 18 months ]
    • Changes in tidal volume over time

  27. Changes in Positive End Expiratory Pressure (PEEP) setting over time [ Time Frame: 18 months ]
    • Changes in Positive End Expiratory Pressure (PEEP) setting over time

  28. Daily and cumulative fluid balance. [ Time Frame: 18 months ]
    • Daily and cumulative fluid balance.

  29. Timing, incidence and duration of ECMO [ Time Frame: 18 months ]
    • Timing, incidence and duration of ECMO

  30. Timing, incidence and duration of neuromuscular blockade [ Time Frame: 18 months ]
    • Timing, incidence and duration of neuromuscular blockade

  31. Mortality at 28 days [ Time Frame: 28 days ]
    Mortality at 28 days

  32. Mortality at 6 months [ Time Frame: 6 months ]
    Mortality at 6 months

  33. Mortality at 1 year [ Time Frame: 1 year ]
    Mortality at 1 year

  34. Organ failure assessment (SOFA) score and/or delta SOFA [ Time Frame: 28 days ]
    • Organ failure free days in the first 28 days, assessed using the sequential organ failure assessment (SOFA) score and/or delta SOFA

  35. Number of patients with ventilation related complications [ Time Frame: 18 months ]
    Number of patients with ventilation related complications e.g. pneumothorax and/or pneumomediastinum

  36. Device malfunction event rate [ Time Frame: 18 months ]
    • Device malfunction event rate

  37. Number of times the advice from the Beacon system is followed [ Time Frame: 18 months ]
    • Number of times the advice from the Beacon system is followed



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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:

Inclusion Criteria

  • 18 years or older
  • Able to consent
  • Have mental capacity

Exclusion Criteria

  • Blood borne viruses: HIV, Hep B, Hep C
  • Blood taken in the last 7 days
  • Under doctor for investigation
  • Haematological disease
  • Currently suffers from infection
  • Needle phobia
  • Problems with veins / vessels
  • Refusal

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04115709


Locations
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Austria
Medical University of Vienna
Vienna, Waehringer Guertel, Austria, A-1090
France
Université Clermont Auvergne
Clermont Ferrand, France, 63003
United Kingdom
Imperial College London, Royal Brompton Hospital campus
London, United Kingdom, SW3 6NP
Sponsors and Collaborators
Imperial College London
European Commission
Mermaid A/C
Aalborg University
Université d'Auvergne
Medical University of Vienna
Sorbonne University
Queen's University, Belfast
Investigators
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Principal Investigator: Brijesh Patel, MBBS MRCP FRCA FFICM PhD Imperial College London
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04115709    
Other Study ID Numbers: 19IC5421
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Acute Respiratory Distress Syndrome
Intensive Care
Device
Beacon Caresystem©
Ventilation
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury