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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Patients meeting the inclusion criteria will be placed on the Hemolung Respiratory Assist System. Patients will be weaned from non-invasive or invasive ventilation and then the Hemolung RAS. Hemolung support will be provided for up to 7 days. Follow-up exams will be performed every 15 days until hospital discharge or 30 days from completion of Hemolung therapy, whichever is later.
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
The ability of the Hemolung to remove a minimum of 50 mL/min of CO2 for up to seven days and reliable performance of the device over the length of use
Time frame: 7 days
The frequency of occurrence of serious adverse events while on Hemolung therapy and up to 30 days from completion of Hemolung therapy.
Time frame: 30 days
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Universitätsmedizin Göttingen
Göttingen, Germany
Asklepios Klinik Barmbek
Hamburg, Germany
Krankenhaus Bethanien
Solingen, Germany