Status:
ENROLLING_BY_INVITATION
Safety and Efficacy of Low-Flow ECMO in a Multi-modal Cohort of Adults in Respiratory Failure
Lead Sponsor:
Institute for Extracorporeal Life Support
Collaborating Sponsors:
Fresenius Medical Care North America
Conditions:
Acute Hypoxemic Respiratory Failure
Mechanical Ventilation
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The current standard of care (SOC) for treatment of patients with acute respiratory distress syndrome (ARDS), inhalation injury, volume overload, and/or pulmonary dysfunction is mechanical ventilation...
Detailed Description
The investigators focus is to demonstrate the safety, feasibility, and efficacy of low-flow ECLS as a treatment for multiple respiratory conditions (including ARDS, volume overload, obstructive and re...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Acute hypoxemic respiratory failure meeting all the following criteria:
- 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 Criteria
- 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)
Exclusion
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06938217
Start Date
May 1 2025
End Date
March 31 2027
Last Update
April 22 2025
Active Locations (1)
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1
Methodist Healthcare System
San Antonio, Texas, United States, 78229