Feasibility Study of the Hemolung Respiratory Assist System (Germany)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Prospective, Non-Randomized Feasibility Study of the Hemolung Respiratory Assist System in Patients With Acute Hypercapnic Respiratory Failure

Conditions
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Hypercapnic Respiratory Failure, COPD, ARDS

Intervention / Treatment
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* Device: Hemolung Respiratory Assist System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed hypercapnic respiratory failure (PaCO2 >50mmHg(6.7kPa)) and falling into one of the five groups Not severely hypoxemic (PaO2/FiO2 ≥ 200 mmHg on PEEP/CPAP ≤ 5 cmH2O) Hemodynamically stable: Mean arterial pressure (MAP) > 65 mmHg without vasopressor support, or MAP > 60 mmHg with a requirement for vasopressor support that can be attributed to sedation or dynamic hyperinflation resulting from mechanical ventilation by the treating investigator. Chronic arrhythmias (e.g., atrial fibrillation) well controlled Minimum platelet count of 100,000/mm3 Minimum red blood cell count of 2.5 mill/μl Group 1: Known or suspected severe COPD, as defined by the GOLD criteria On non-invasive positive pressure mechanical ventilation > 1hour with either: PaCO2 > 55 mmHg with pH < 7.25 OR PaCO2 > 55 mmHg with < 5mmHg decrease from baseline and pH < 7.30 Group 2: Intubated or tracheostomized patients with hypercapnic respiratory failure who either: Has failed at least 2 weaning attempts or Has failed at least 1 attempt and wishes not to be invasively mechanically ventilated Group 3: Patient on NIPPV due to hypercapnic respiratory failure who has failed at least 2 weaning attempts and has refused intubation Group 4: Patients with hypercapnic respiratory failure who are failing optimal NIPPV or demonstrate a complete intolerance to NIPPV and IMV is considered undesirable Group 5: Patients who are on IMV and would benefit from the application of lung protective ventilation, and in whom this would not be achieved without significant worsening of respiratory failure On IMV for at least 12 hours pH <7.30 due to respiratory acidosis Exclusion Criteria: Presence of acute, uncontrolled arrhythmia Acute ischemic heart disease Presence of bleeding diathesis Significant abnormality or weakness/paralysis of respiratory muscles due to a know muscular dystrophy or neurologic disorder Recent (< 7 days) prolonged (>24 hrs) use of muscle paralyzing agents Cerebrovascular accident, intracranial bleed, head injury or other neurologic disorder likely to affect ventilation Coma from any cause, or decreased consciousness Hypersensitivity to heparin or previous heparin induced thrombocytopenia Recent (< 6 months) major chest abdominal trauma or surgery Presence of septic shock Presence of a significant pneumothorax or bronchopleural fistula History of uncontrolled major psychiatric disorder Pregnant women Known to have AIDS or to have symptomatic HIV Received chemotherapy or radiation within the previous 90 days Received an organ transplant other than corneal transplants Received or currently receiving immunosuppressive therapy, excluding corticosteroids within the last 3 months Presence of severe renal or liver failures Known vascular abnormality which would complicate or prevent successful insertion of the vascular access catheter in either the right internal jugular vein or right femoral vein Presence of another catheter in both the right internal jugular vein and right femoral vein that cannot be moved to allow insertion of the Hemolung catheter in one of these vessels.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemolung Respiratory Assist System<br> | Device: Hemolung Respiratory Assist System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 7 days | 
| The frequency of occurrence of serious adverse events while on Hemolung therapy and up to 30 days from completion of Hemolung therapy. |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hypercapnic respiratory failure, COPD, ARDS