🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Contributor sign in
Latest
Clinical Trials in Australia / NCT05562505
Recruiting Not applicable

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

NCT05562505 · tracked via the Priya Life Science Australia tracker
Phase
Not applicable
Started
2022-11-28
Last updated
2024-08-09

Condition(s) studied

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)

Trial sites (7)

FacilityCityRegionStatus
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

Other trials for the same condition

Official registry record

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.

View NCT05562505 on ClinicalTrials.gov ↗ ← All trials in Australia