Using ECMO to help patients with severe respiratory failure recover

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Charite Universitatmedizin
  Berlin, Germany Recruiting

Study contacts

• Principal investigator: Aidan Burrell, MBBS — Monash University
• Study coordinator: Stephanie M Hunter
• Email: Stephanie.Hunter@monash.edu
• Phone: +61 3 9903 0646

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.