Feasibility Study of the Hemolung Respiratory Assist System
A Prospective, Non-Randomized Feasibility Study of the Hemolung Respiratory Assist System in COPD Patients With Acute Respiratory Failure That Are at a 50% Risk of Failing Non Invasive Ventilation (NIV)
1 other identifier
interventional
2
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2009
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2009
CompletedFirst Posted
Study publicly available on registry
October 1, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedAugust 10, 2017
August 1, 2017
9 months
September 30, 2009
August 9, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Frequency of occurrence of serious adverse events while on Hemolung therapy and up to 30 days after cessation of therapy and decannulation.
30 days
Percentage of patients requiring Mechanical Ventilation
7 days
Secondary Outcomes (10)
Improvement in patient self assessment of dyspnea using visual analog scale pre- to post-Hemolung therapy.
7 days
Change in Minute Volume (VE) pre- to end-Hemolung therapy
7 days
Number of days in the ICU
30 days
Number of days in the hospital
30 days
Number of days alive and off mechanical ventilation for > 48 hours through the end of Day 30 following completion of Hemolung therapy
30 days
- +5 more secondary outcomes
Study Arms (1)
Hemolung Respiratory Assist System
EXPERIMENTALInterventions
Patients meeting the inclusion criteria will be placed on the Hemolung Respiratory Assist System. Patients will be weaned from non-invasive ventilation and then the Hemolung. Hemolung support will be provided for up to 7 days. Follow-up exams will be performed every 15 days until hospital discharge or 30 days from completion of Hemolung therapy, whichever is later.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Artemis Health Institute
Gurgaon, Haryana, 122001, India
Related Publications (1)
Burki NK, Mani RK, Herth FJF, Schmidt W, Teschler H, Bonin F, Becker H, Randerath WJ, Stieglitz S, Hagmeyer L, Priegnitz C, Pfeifer M, Blaas SH, Putensen C, Theuerkauf N, Quintel M, Moerer O. A novel extracorporeal CO(2) removal system: results of a pilot study of hypercapnic respiratory failure in patients with COPD. Chest. 2013 Mar;143(3):678-686. doi: 10.1378/chest.12-0228.
PMID: 23460154DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
RK Mani, MD
Artemis Health Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2009
First Posted
October 1, 2009
Study Start
October 1, 2009
Primary Completion
July 1, 2010
Study Completion
August 1, 2010
Last Updated
August 10, 2017
Record last verified: 2017-08