Feasibility Study of the Hemolung Respiratory Assist System (NCT00987740) | Clinical Trial Compass
CompletedNot Applicable
Feasibility Study of the Hemolung Respiratory Assist System
India2 participantsStarted 2009-10
Plain-language 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.
Who can participate
Age range21 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 wom…
What they're measuring
1
Frequency of occurrence of serious adverse events while on Hemolung therapy and up to 30 days after cessation of therapy and decannulation.
Timeframe: 30 days
2
Percentage of patients requiring Mechanical Ventilation