A Prospective, Non-Randomized Feasibility Study of theHemolung? Respiratory Assist System in COPD Patients with Acute Respiratory Failure that are at a 50% Risk of FailingNon Invasive Ventilation (NIV)

ALung Technologies, Inc.333 East Carson, Suite 517APittsburgh PA 152190 个研究点目标入组 10 人开始时间: 待定最近更新: 2021年11月24日

研究概览

暂无简介。

• 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

• 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

发起方

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