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 range
21 Years – 80 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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