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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.
Age
21 - 80 years
Sex
ALL
Healthy Volunteers
No
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Ruhrlandklinik Das Lungenzentrum Essen-Heidhausen Abt.: Pneumologie
Essen, North Rhine-Westphalia, Germany
Universitätsklinikum Bonn
Bonn, Germany
Klinik Donaustauf
Donaustauf, Germany
Universitätsmedizin Göttingen
Göttingen, Germany
Asklepios Klinik Barmbek
Hamburg, Germany
Krankenhaus Bethanien
Solingen, Germany
Start Date
December 1, 2009
Primary Completion Date
May 1, 2012
Completion Date
May 1, 2012
Last Updated
September 30, 2019
21
ACTUAL participants
Hemolung Respiratory Assist System
DEVICE
Lead Sponsor
Alung Technologies
Data Source & Attribution
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