Feasibility Study of the Hemolung Respiratory Assist System

Alung Technologies

Status

Completed

Conditions

Hypercapnic Respiratory Failure, COPD

Treatments

Device: Hemolung Respiratory Assist System

Study type

Interventional

Funder types

Industry

Identifiers

NCT00987740

HL-CA-2000

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

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