Acute respiratory distress syndrome (ARDS) Respiratory
Conditions
Interventions
This study is a two-arm, parallel-group, multi-centre, open-label, individually randomised controlled trial of rest or moderate mechanical ventilation in patients under ECMO support, with a 6-month in
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Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Reversible cause of ARDS as determined by the treating physician prior to VV-ECMO cannulation 2. Adult participants (18 years and over) undergoing invasive mechanical ventilation 3. Requiring VV-ECMO for severe ARDS. Within the context of this study, ‘ARDS’ will be defined using the Berlin definition criteria applied prior to ECMO cannulation: 3.1. Symptoms must appear within one week of a known clinical event or worsen within that time 3.2. Chest x-ray or CT scan must show bilateral opacities that aren't fully explained by other factors 3.3. Respiratory failure can't be caused by cardiac failure or fluid overload 3.4. The ratio of partial pressure of oxygen in arterial blood (PaO2) to the fraction of inspired oxygen (FiO2) determines the severity of ARDS: 3.4.1. Mild ARDS: PaO2/FiO2 of 200-300 mmHg / 27-40 kPa 3.4.2. Moderate ARDS: PaO2/FiO2 of 100-200 mmHg / 13-27 kPa 3.4.3. Severe ARDS: PaO2/FiO2 less than 100 mmHg / 13 kPa
Exclusion criteria
Exclusion criteria: 1. >48 hours from VV-ECMO initiation 2. Participant likely to die or withdrawal of life sustaining therapy within 48 hours 3. Bronchopleural fistula
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time from randomisation to successful decannulation from VV-ECMO (defined as 48 hours free of ECMO), incorporating death as a competing risk | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes represent the core outcomes defined for trials of mechanical ventilation and ECMO. These include: 1. Days alive and free of ECMO (DAFE) up to day 28 and 60 2. Daily Organ Support for participants on ECMO (DOSE) score up to 28 days post-randomization 3. Mortality recorded at 60 days, 6 months, and 1 year 4. First successful liberation from invasive mechanical ventilation, i.e. >48 hours of spontaneous ventilation (CPAP or HFNC) 5. Duration of invasive mechanical ventilation 6. Serious adverse events recorded to hospital discharge (including AEs of specific interest related to NAV and ECMO as listed below) 7. Length of total ICU and hospital stay 8. Health-related quality of life measured using EQ-5D-5L at 6 and 12 months 9. Disability measured using the Modified Rankin Scale at 6 and 12 months | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed