By Nathaniel Marchetti, DO
Temple is taking part in a clinical trial to evaluate a new device that may improve outcomes among patients with respiratory failure by reducing—or eliminating—the time they are subjected to invasive mechanical ventilation.
Some patients with acute COPD exacerbation experience hypercapnic respiratory failure. Standard of care for such patients is initially respiratory support through noninvasive positive pressure ventilation via a mask, but a small percentage require intubation and invasive mechanical ventilation. Invasive mechanical ventilation increases mortality risk, probably due to physical deconditioning and the greater likelihood of contracting pneumonia.
The ALung Hemolung® device employs minimally invasive extracorporeal CO2 removal (ECCO2R)—a catheter-based, dialysis-like technique—to relieve hypercapnia without taxing the lungs. In doing so, the device may allow patients to avoid invasive mechanical ventilation—or, if the patient has already progressed to a ventilator, to minimize the time spent on it.
Patients using the Hemolung® device without a ventilator are able to walk and move around much more easily, making physical therapy possible. Compared with hypoxemia-focused treatment solutions like ECMO, the low flow rate (approximately 500 ml/min, vs. 2.5–3 liters/min with ECMO) and smaller cannula reduce the risk of bleeding complications and hemolysis.
The multicenter VENT-AVOID trial (NCT03255057) will examine the safety and efficacy of the ALung Hemolung® device as an alternative or companion to invasive ventilation among patients experiencing acute COPD exacerbation who are failing, or have already failed, on standard-of-care therapies. The primary outcome measure for the study is ventilator-free days. Sponsored by ALung Technologies, the trial is being conducted under an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration.
To refer a patient for the VENT-AVOID trial, please contact 215-707-1359. ■