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

Launched by AUSTRALIAN AND NEW ZEALAND INTENSIVE CARE RESEARCH CENTRE · Sep 26, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating whether adding a treatment called venovenous ECMO (a type of life support that helps with breathing) to standard mechanical ventilation can help patients with severe breathing problems caused by conditions like COVID-19. The goal is to see if this combined approach leads to more days without needing intensive care by the time patients reach 60 days after starting treatment. The trial is currently looking for participants aged 18 to 65 who have recently developed serious breathing issues and have been on mechanical ventilation for less than a week.

Eligible participants can expect close monitoring and support as they receive either the standard mechanical ventilation treatment or the additional ECMO treatment. It’s important to note that certain health conditions or immediate needs might disqualify someone from participating, such as being too close to being extubated (removing the breathing tube) or having specific chronic health issues. If you or a loved one is interested, the clinical team will provide detailed information about the trial and help determine eligibility.

Gender

ALL

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.