A Prospective, Multi-Center, Randomized, Controlled, Pivotal Trial to Validate the Safety and Efficacy of the Hemolung^® Respiratory Assist System for COPD Patients Experiencing an Acute Exacerbation Requiring Ventilatory Support

Registered on ClinicalTrials.gov

Primary Study Objective
To demonstrate the safety and efficacy of using the Hemolung RAS to provide low-flow ECCO2R as an alternative or adjunct to invasive mechanical ventilation versus standard of care invasive mechanical ventilation alone to increase ventilator-free days for COPD patients who require respiratory support due to an acute exacerbation of their COPD.

Patient Population
Patients with underlying COPD who are experiencing an acute exacerbation and require either noninvasive ventilatory support (Stratum 1) or immediate intubation and invasive mechanical ventilation (Stratum 2) due to Type II hypercapnic respiratory failure.

Primary Safety and Efficacy Endpoint
The amount of time in the first five days following randomization that a patient is free of Invasive MV and alive.

Investigators
Principal Investigator: Nicholas Hill, MD Tufts University Medical Center
Co-Principal Investigator: L. Keith Scott, MD MSc FCCM, LSU Health – Shreveport

Participating in the Trial
Investigators interested in participating in the trial are encouraged to info@alung.com.