BridgeMD
New treatment option for Mechanical Ventilation Complication
Official title Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure
ClinicalTrials.gov ID: NCT05562505
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Mechanical ventilation of \<7 days
- Moderate to severe respiratory failure, as demonstrated by two P:F ratios \ 150mmHg are permitted between the two trial inclusion ABGs.
- Trial of proning (unless contraindicated)
You likely can't join if
- 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
See the full eligibility criteria
- 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 are permitted between the two trial inclusion ABGs.
- Trial of proning (unless contraindicated)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Darlinghurst, New South Wales, Australia
- Sydney, New South Wales, Australia
- Brisbane, Queensland, Australia
- Gold Coast, Queensland, Australia
- Melbourne, Victoria, Australia
- Perth, Western Australia, Australia
- Berlin, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Darlinghurst, New South Wales, Australia; Sydney, New South Wales, Australia; Brisbane, Queensland, Australia; Gold Coast, Queensland, Australia; Melbourne, Victoria, Australia; Perth, Western Australia, Australia and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.