Actively Recruiting
Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure
Led by Australian and New Zealand Intensive Care Research Centre · Updated on 2024-08-09
140
Participants Needed
7
Research Sites
217 weeks
Total Duration
On this page
Sponsors
A
Australian and New Zealand Intensive Care Research Centre
Lead Sponsor
T
The Alfred
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients ≥18 to 65 years old
- 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
- Mechanical ventilation of <7 days
- 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.
- Trial of proning (unless contraindicated)
You will not qualify if you...
- The patient will be extubated today or tomorrow (i.e. will not remain intubated and ventilated the day after tomorrow)
- Cardiogenic cause of respiratory failure
- Chronic hypercapnic respiratory failure defined as PaCO2 > 60 mmHg in the outpatient setting
- Home mechanical ventilation (non-invasive ventilation or via tracheotomy) except for CPAP/BIPAP used solely for sleep disordered breathing
- Confirmed diffuse alveolar haemorrhage from vasculitis
- Neurologic conditions, i.e. undergoing treatment for intracranial hypertension
- Currently receiving any form of ECMO (e.g., venovenous, venoarterial, or hybrid configuration)
- Patient needing immediate VV ECMO (as per EOLIA criteria)
- The patient is moribund and deemed unlikely to survive past 24 hours (as determined by the clinical team)
- The patient is being transitioned to palliative care
- Contraindications to anticoagulation (e.g., active GI bleeding, bleeding predisposition, severe trauma)
- Previous hypersensitivity/anaphylactic reaction to heparin or heparin-induced thrombocytopenia
- Participation or Consent is declined, OR
- Unable to identify or Contact surrogate decision maker.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Actively Recruiting
2
Royal Prince Alfred
Sydney, New South Wales, Australia
Actively Recruiting
3
The Prince Charles Hospital
Brisbane, Queensland, Australia
Actively Recruiting
4
Gold Coast University Hospital
Gold Coast, Queensland, Australia, 4217
Actively Recruiting
5
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
6
Fiona Stanley Hospital
Perth, Western Australia, Australia, 6150
Not Yet Recruiting
7
Charite Universitatmedizin
Berlin, Germany, 10117
Actively Recruiting
Research Team
S
Stephanie M Hunter
CONTACT
T
Tony Trapani
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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