Using ECMO to help patients with severe respiratory failure recover

A Randomised Controlled Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure

This study is testing if using a special breathing machine called ECMO along with regular ventilation can help patients with severe breathing problems recover faster and spend less time in intensive care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 140 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Australian and New Zealand Intensive Care Research Centre (other)
• Locations: 7 sites (Darlinghurst, New South Wales and 6 other locations)
• Trial ID: NCT05562505 on ClinicalTrials.gov

What this trial studies

This trial investigates whether adding venovenous ECMO to mechanical ventilation can improve outcomes for patients with moderate to severe acute hypoxic respiratory failure. The study aims to determine if this approach increases the number of days patients can spend outside of intensive care by reducing the complications associated with mechanical ventilation. By minimizing the need for sedation and allowing for earlier mobilization, the trial seeks to enhance recovery and reduce long-term health issues. A total of 140 patients will be recruited for this multicenter randomized controlled trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with acute hypoxemic respiratory failure requiring mechanical ventilation for less than 7 days.

Not a fit: Patients who are expected to be extubated soon or have cardiogenic causes of respiratory failure may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved recovery times and reduced complications for patients suffering from severe respiratory failure.

How similar studies have performed: Other studies have shown promise in using ECMO for respiratory failure, suggesting that this approach may be beneficial.

Eligibility criteria

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.

Where this trial is running

Darlinghurst, New South Wales and 6 other locations

• St Vincent's Hospital Sydney — Darlinghurst, New South Wales, Australia (RECRUITING)
• Royal Prince Alfred — Sydney, New South Wales, Australia (RECRUITING)
• The Prince Charles Hospital — Brisbane, Queensland, Australia (RECRUITING)
• Gold Coast University Hospital — Gold Coast, Queensland, Australia (RECRUITING)
• The Alfred Hospital — Melbourne, Victoria, Australia (RECRUITING)
• Fiona Stanley Hospital — Perth, Western Australia, Australia (NOT_YET_RECRUITING)
• Charite Universitatmedizin — Berlin, Germany (RECRUITING)

Study contacts

• Principal investigator: Aidan Burrell, MBBS — Monash University
• Study coordinator: Stephanie M Hunter

Conditions: Mechanical Ventilation Complication, Hypoxemia, Acute Respiratory Distress Syndrome Due to COVID-19, COVID-19 Respiratory Infection, Pneumonia, Extracorporeal Membrane Oxygenation, Intensive Care Unit, ECMO