NCT06938217
Safety and Efficacy of Low-Flow ECMO in a Multi-modal Cohort of Adults in Respiratory Failure
Enrolling by Invitation
NAAges 18–65InterventionalDevice feasibilityInstitute for Extracorporeal Life SupportInvestigator-initiated
~30 participants
Updated 2025-04-22 on ClinicalTrials.gov
What's tested:Low-flow ECMO
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ventilator-free days
Measured over Documented at 28 Days
Conditions
Where it's being run
1 sites across 1 statesTexas1
Study leadership
- Jeffrey D DellaVolpe, MD, MPH · PRINCIPAL_INVESTIGATOR · Institute for Extracorporeal Life Support
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
New or worsening respiratory symptoms developing within 2 weeks prior to the onset of need for oxygen or respiratory support
Endotracheal mechanical ventilation for ≤ 5 days
PaO2/FiO2 ≤ 200 mmHg for at least 6 hours, or for at least two readings one hour apart
Male or non-pregnant female
Admitted to the ICU at MHS
Age ≥ 18 years
Exclusion
Hypoxemia is primarily attributable to fluid overload from acute heart failure
Hypoxemia is primarily attributable to pulmonary embolism
Hypoxemia is primarily attributable to status asthmaticus
Extubation is planned or anticipated on the day of screening
ICU discharge is planned or anticipated on the day of screening
The patient is moribund and deemed unlikely to survive past 24 hours (as determined by the clinical team)
The patient has limited code status, ordered for comfort measures only, or is in hospice
Patients over 65 years of age
Currently receiving any form of ECLS (ex. veno-venous, veno-arterial, or hybrid configuration)
ΔPL-dyn ≤ 20 or Static ΔP ≤ 15 cm H2O while receiving VT 6 mL/kg (i.e. normalized elastance \< 2.5 cmH2O/mL/kg)
Chronic hypercapnic respiratory failure defined as PaCO2 \> 60mmHg in the outpatient setting
Home mechanical ventilation (non-invasive ventilation or via tracheotomy), not CPAP
Severe hypoxemia with PaO2:FiO2 \< 80mmHg for \>6 hours at time of screening
Severe hypercapnic respiratory failure with pH \< 7.15 and PaCO2 \> 60mmHg for \>6 hours at time of screening
Expected mechanical ventilation duration \< 48 hours at time of screening
Confirmed diffuse alveolar hemorrhage from vasculitis
Contraindications to limited anticoagulation (ex. active GI bleeding, bleeding diathesis)
Respiratory failure known or suspected to be caused by COVID-19
Cirrhosis of the liver (as classified stage C of the Child-Pugh Score)
Pregnancy
Inability to tolerate extracorporeal therapy (MAP\<65 mmHg despite fluid resuscitation and vasopressors)
Unable to obtain informed consent from either patient or legally authorized representative (LAR)
What this trial measures
- Ventilator-free daysDocumented at 28 Days
Ventilator-free days in the first 28 days