COPD affects 30 million Americans and is the third leading cause of death in the United States behind cancer and heart disease.
Acute exacerbations, defined as a sudden worsening of COPD symptoms, are a major cause of morbidity and mortality in COPD patients. For patients with severe exacerbations, high levels of carbon dioxide can result in respiratory failure and the need for intubation and mechanical ventilation as life saving measures. Unfortunately, mechanical ventilation is associated with many side effects, and in-hospital mortality remains as high as 30%.
ECCO₂R therapy with the Hemolung RAS allows carbon dioxide to be removed from the blood independently of the lungs with the aim of facilitating the avoidance or reduction of intubation and invasive mechanical ventilation.
CAUTION: The Hemolung RAS is an Investigational Device and limited by United States law to investigational use.
The VENT-AVOID Trial is 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. The study is being conducted under an FDA Investigational Device Exemption (IDE).
Forty hospitals will enroll at least 300 patients in the trial. COPD patients suffering severe exacerbations will be eligible for the study if they are either 1) failing non-invasive ventilation and presenting a high risk of being intubated and mechanically ventilated or 2) have required intubation and invasive mechanical ventilation due to acute respiratory failure.
Eligibility for the trial is determined by the hospital’s critical care team. If you care for a patient facing a severe exacerbation and are interested in learning more about the VENT-AVOID study, please contact the patient’s physician. Only patients admitted to one of the forty study centers can be included in the clinical trial.