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
Basis for the Study
This study is being conducted under an FDA approved IDE to establish the safety and efficacy of an investigational Class III medical device for FDA pre-market approval (PMA) via a pivotal RCT to scientifically validate the indication for its use in acute exacerbation of COPD.
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.
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
Ventilator-free days measured from randomization through 60 days following randomization (VFD-60).
Principal Investigator: Nicholas Hill, MD Tufts University Medical Center
Participating in the Trial
Investigators interested in participating in the trial are encouraged to Contact ALung.