Status:
COMPLETED
Decision Support System to Evaluate VENTilation in ARDS
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
European Commission
Mermaid A/C
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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 exchan...
Detailed Description
The study is a randomised control trial, comparing the effects of mechanical ventilation in ARDS provided as standard care, with mechanical ventilation set according to the advice of the Beacon Care s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2021
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04115709
Start Date
March 19 2020
End Date
August 30 2021
Last Update
September 16 2021
Active Locations (3)
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1
Medical University of Vienna
Vienna, Waehringer Guertel, Austria, A-1090
2
Université Clermont Auvergne
Clermont-Ferrand, France, 63003
3
Imperial College London, Royal Brompton Hospital campus
London, United Kingdom, SW3 6NP