Feasibility Study of the Hemolung Respiratory Assist System

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 in patients with hypercapnic respiratory failure associated with acute exacerbation of chronic obstructive pulmonary disease (COPD) and a 50% likelihood of failure of noninvasive positive pressure ventilation leading to intubation and mechanical ventilation.

Official Title
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A Prospective, Non-Randomized Feasibility Study of the Hemolung Respiratory Assist System in COPD Patients With Acute Respiratory Failure That Are at a 50% Risk of Failing Non Invasive Ventilation (NIV)

Conditions
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Hypercapnic Respiratory Failure, COPD

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: Moderate or severe COPD, as defined by the GOLD criteria Acute exacerbation of COPD (sustained worsening of patient's condition necessitating a change in regular medication) 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 Not severely hypoxemic (PaO2/FiO2 ≥ 200 mmHg on PEEP/CPAP ≤ 5 cmH2O) Hemodynamically stable (mean arterial pressure > 65 mmHg without vasopressor support) 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 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 with could complicate or prevent successful insertion of the vascular access catheter in the right femoral vein Presence of another catheter in the right femoral vein that cannot be moved Presence of an inferior vena cava filter

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 ventilation and then the Hemolung. 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 |
| --- | --- | --- |
| Frequency of occurrence of serious adverse events while on Hemolung therapy and up to 30 days after cessation of therapy and decannulation. |  | 30 days | 
| Percentage of patients requiring Mechanical Ventilation |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in patient self assessment of dyspnea using visual analog scale pre- to post-Hemolung therapy. |  | 7 days | 
| Change in Minute Volume (VE) pre- to end-Hemolung therapy |  | 7 days | 
| Number of days in the ICU |  | 30 days | 
| Number of days in the hospital |  | 30 days | 
| Number of days alive and off mechanical ventilation for > 48 hours through the end of Day 30 following completion of Hemolung therapy |  | 30 days | 
| Percentage of patients requiring sedation, and hours of sedation |  | 30 days | 
| Number of days on Non-Invasive Positive Pressure Ventilation (NIPPV) |  | 30 days | 
| For patients requiring Mechanical Ventilation, number of days on Mechanical Ventilation |  | 30 days | 
| Duration of weaning time from NIPPV |  | 7 days | 
| Duration of weaning time from Hemolung therapy |  | 7 days | 

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