None listed
Conditions
Interventions
Intervention1: Hemolung Device: Upto 7 days.
Control Intervention1: NIL: NIL
Sponsors
ALung Technologies, Inc.
333 East Carson, Suite 517A
Pittsburgh PA 15219
M/s Qualtran Auriga Research
3/15 Kirti Nagar Industrial Area
New Delhi - 110015
Eligibility
Inclusion criteria
Inclusion criteria: &#61623; Moderate or severe COPD, as defined by the GOLD criteria &#61623; Acute exacerbation of COPD (sustained worsening of patient?s condition necessitating a change in regular medication) &#61623; 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 &#61623; Not severely hypoxemic (PaO2/FiO2 &#8805; 200 mmHg on PEEP/CPAP &#8804; 5 cmH2O) &#61623; Hemodynamically stable (mean arterial pressure > 65 mmHg without vasopressor support) &#61623; Chronic arrhythmias (e.g., atrial fibrillation) well controlled &#61623; Minimum platelet count of 100,000/mm3 &#61623; Minimum red blood cell count of 2.5 mill/&#956;l &#61623; Aged from 21to 80 years old
Exclusion criteria
Exclusion criteria: &#61623; Presence of acute, uncontrolled arrhythmia &#61623; Acute ischemic heart disease &#61623; Presence of bleeding diathesis &#61623; Significant abnormality or weakness/paralysis of respiratory muscles due to a know muscular dystrophy or neurologic disorder &#61623; Recent (< 7 days) prolonged (>24 hrs) use of muscle paralyzing agents &#61623; Cerebrovascular accident, intracranial bleed, head injury or other neurologic disorder likely to affect ventilation &#61623; Coma from any cause, or decreased consciousness &#61623; Hypersensitivity to heparin or previous heparin induced thrombocytopenia &#61623; Recent (< 6 months) major chest abdominal trauma or surgery &#61623; Presence of septic shock &#61623; Presence of a significant pneumothorax or bronchopleural fistula &#61623; History of uncontrolled major phychiatric disorder &#61623; Pregnant women &#61623; Known to have AIDS or to have symptomatic HIV &#61623; Received chemotherapy or radiation within the previous 90 days &#61623; Received an organ transplant other than corneal transplants &#61623; Received or currently receiving immunosuppressive therapy, excluding corticosteroids within the last 3 months &#61623; Presence of severe renal or liver failures &#61623; 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 &#61623; Presence of another catheter in both the right internal jugular vein and right femoral vein that cannot be moved
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| a. Improvement in patient self assessment of dyspnea using visual analog scale pre- to post-Hemolung therapy. b. Change in Minute Volume (VE) pre- to end-Hemolung therapy c. Number of days in the ICU d. Number of days in the hospital e. Number of days alive and off mechanical ventilation for > 48 hours through the end of Day 30 following completion of Hemolung therapy f. Percentage of patients requiring sedation, and hours of sedation g. Number of days on NIPPV h. For patients requiring Mechanical Ventilation, number of days on Mechanical Ventilation i. Duration of weaning time from NIPPV j. Duration of weaning time from Hemolung therapyTimepoint: During the Hemolung Therapy | — |
Countries
India
Contacts
Public ContactDr. R. K. Mani
Outcome results
None listed