Feasibility study to evaluate the safety of the Hemolung in patients with hypercapnic respiratory failure associated with acute exacerbation of COPD and have a 50% likelihood of failure of noninvasive positive pressure ventilation (NIPPV) leading to intubation and mechanical ventilatio

Not Applicable

Completed

Registration Number: CTRI/2009/091/000856

Lead Sponsor: ALung Technologies, Inc.333 East Carson, Suite 517APittsburgh PA 15219

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

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:
o PaCO2 > 55 mmHg with pH < 7.25 OR
o 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
 Aged from 21to 80 years old

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 phychiatric 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 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The efficacy of the Hemolung will be assessed by the: - Percentage of patients requiring Mechanical Ventilation.Timepoint: At least 65% of subjects will meet this efficacy endpoint during the Hemolung therapy.

Secondary Outcome Measures

Name	Time	Method
a. Improvement in patient self assessment of dyspnea using visual analog scale pre- to post-Hemolung therapy. <br>b. Change in Minute Volume (VE) pre- to end-Hemolung therapy <br>c. Number of days in the ICU <br>d. Number of days in the hospital <br>e. Number of days alive and off mechanical ventilation for > 48 hours through the end of Day 30 following completion of Hemolung therapy <br>f. Percentage of patients requiring sedation, and hours of sedation <br>g. Number of days on NIPPV <br>h. For patients requiring Mechanical Ventilation, number of days on Mechanical Ventilation <br>i. Duration of weaning time from NIPPV <br>j. Duration of weaning time from Hemolung therapyTimepoint: During the Hemolung Therapy