Hypercapnic Respiratory Failure, COPD
Conditions
Keywords
hypercapnic respiratory failure, COPD
Brief summary
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.
Interventions
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.
Sponsors
Alung Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Improvement in patient self assessment of dyspnea using visual analog scale pre- to post-Hemolung therapy. | 7 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 |
| Percentage of patients requiring sedation, and hours of sedation | 30 days |
| Duration of weaning time from Hemolung therapy | 7 days |
Countries
India
Outcome results
None listed