Mechanical Ventilation ComplicationHypoxemiaAcute Respiratory Distress Syndrome Due to COVID-19COVID-19 Respiratory InfectionPneumoniaExtracorporeal Membrane Oxygenation
Investigational drug(s) / intervention(s)
Venovenous ECMO
Venovenous ECMO: ECMO therapy for patients with hypoxic respiratory failure.
Study summary
To determine whether a strategy of adding venovenous ECMO to mechanical ventilation, as compared to mechanical ventilation alone, increases the number of intensive care free days at day 60, in patients with moderate to severe acute hypoxic respiratory failure.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patients ≥18 to 65 years old
2. Acute hypoxemic respiratory failure characterised by new or worsening respiratory symptoms developing within 2 weeks prior to the onset of need for oxygen or respiratory support
3. Mechanical ventilation of \<7 days
4. Moderate to severe respiratory failure, as demonstrated by two P:F ratios \<150mmHg at least 6 hours apart. Arterial Blood Gases (ABG) with P:F ratio \> 150mmHg are permitted between the two trial inclusion ABGs.
5. Trial of proning (unless contraindicated)
Exclusion Criteria:
1. The patient will be extubated today or tomorrow (i.e. will not remain intubated and ventilated the day after tomorrow)
2. Cardiogenic cause of respiratory failure
3. Chronic hypercapnic respiratory failure defined as PaCO2 \> 60 mmHg in the outpatient setting
4. Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep disordered breathing
5. Confirmed diffuse alveolar haemorrhage from vasculitis
6. Neurologic conditions, i.e. undergoing treatment for intracranial hypertension
7. Currently receiving any form of ECMO (e.g., venovenous, venoarterial, or hybrid configuration)
8. Patient needing immediate VV ECMO (as per EOLIA criteria)
9. The patient is moribund and deemed unlikely to survive past 24 hours (as determined by the clinical team)
10. The patient is being transitioned to palliative care
11. Contraindications to anticoagulation (e.g., active GI bleeding, bleeding predisposition, severe trauma)
12. Previous hypersensitivity/anaphylactic reaction to heparin or heparin-induced thrombocytopenia
13. Participation or Consent is declined, OR
14. Unable to identify or Contact surrogate decision maker.
Primary outcome measure(s)
Intensive Care Unit Free days to Day 60 — 60 Days Days alive and free from ICU to Day 60. Day Day 0 is randomisation day, with any portion of a day is spent in an ICU counted as a day.
Trial sites (7)
Facility
City
Region
Status
St Vincent's Hospital Sydney
Darlinghurst
New South Wales
Recruiting
Royal Prince Alfred
Sydney
New South Wales
Recruiting
The Prince Charles Hospital
Brisbane
Queensland
Recruiting
Gold Coast University Hospital
Gold Coast
Queensland
Recruiting
The Alfred Hospital
Melbourne
Victoria
Recruiting
Fiona Stanley Hospital
Perth
Western Australia
Not Yet Recruiting
Charite Universitatmedizin
Berlin
Germany
Recruiting
More Australian and New Zealand Intensive Care Research Centre trials in Australia
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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