Safety and Efficacy of Low-Flow ECMO in a Multi-modal Cohort of Adults in Respiratory Failure

Launched by INSTITUTE FOR EXTRACORPOREAL LIFE SUPPORT · Apr 14, 2025

Keywords

ClinConnect Summary

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 restrictive pulmonary diseases, hypoxia) in conjunction with MV.

BACKGROUND

The two most significant trials in the last five years investigating strategies around low-flow ECLS with the intent of CO2 reduction/ventilator reduction are as follows:

* SUPERNOVA Multi-Center Phase II Study in Europe and Canada: In 2019 Combes et al assessed the feasibility and safety of lower CO2 extraction ECLS d...

Gender

ALL

Eligibility criteria

• • 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)