Hypercapnic Respiratory Failure, COPD, ARDS Clinical Trial
Official title:
A Prospective, Non-Randomized Feasibility Study of the Hemolung Respiratory Assist System in Patients With Acute Hypercapnic Respiratory Failure
The purpose of this study is to evaluate the safety and efficacy of the Hemolung Respiratory Assist System (RAS) in patients with hypercapnic respiratory failure.
The objective of the feasibility study is to evaluate the safety and efficacy of the Hemolung
RAS in patients with hypercapnic respiratory failure in five groups of patients:
Group 1: COPD patients with an acute exacerbation and have a 50% likelihood of failure of
noninvasive positive pressure ventilation (NIPPV) leading to intubation and mechanical
ventilation
Group 2: Patients with hypercapnic respiratory failure on invasive mechanical ventilation who
have either:
- Failed two or more weaning attempts OR
- Failed one or more weaning attempts and do not wish to be invasively mechanically
ventilated.
Group 3: Patients with hypercapnic respiratory failure on noninvasive positive pressure
ventilation who have failed two weaning attempts and do not wish to be invasively
mechanically ventilated.
Group 4: Patients with hypercapnic respiratory failure who in the view of the treating
physician are declining on optimized non-invasive positive pressure ventilation OR
demonstrate a complete intolerance of non-invasive positive pressure ventilation for any
reason and invasive mechanical ventilation is considered undesirable by the treating
physician.
Group 5: Patients who are currently invasively mechanically ventilated and in the view of the
treating physician would benefit from the application of protective lung ventilation, and in
whom this cannot be achieved without significant worsening of respiratory failure.
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