Feasibility Study of the Hemolung Respiratory Assist System
Primary Purpose
Hypercapnic Respiratory Failure, COPD
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Hemolung Respiratory Assist System
Sponsored by
About this trial
This is an interventional treatment trial for Hypercapnic Respiratory Failure, COPD focused on measuring hypercapnic respiratory failure, COPD
Eligibility Criteria
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
Sites / Locations
- Artemis Health Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hemolung Respiratory Assist System
Arm Description
Outcomes
Primary Outcome Measures
Frequency of occurrence of serious adverse events while on Hemolung therapy and up to 30 days after cessation of therapy and decannulation.
Percentage of patients requiring Mechanical Ventilation
Secondary Outcome Measures
Improvement in patient self assessment of dyspnea using visual analog scale pre- to post-Hemolung therapy.
Change in Minute Volume (VE) pre- to end-Hemolung therapy
Number of days in the ICU
Number of days in the hospital
Number of days alive and off mechanical ventilation for > 48 hours through the end of Day 30 following completion of Hemolung therapy
Percentage of patients requiring sedation, and hours of sedation
Number of days on Non-Invasive Positive Pressure Ventilation (NIPPV)
For patients requiring Mechanical Ventilation, number of days on Mechanical Ventilation
Duration of weaning time from NIPPV
Duration of weaning time from Hemolung therapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00987740
Brief Title
Feasibility Study of the Hemolung Respiratory Assist System
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
August 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alung Technologies
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercapnic Respiratory Failure, COPD
Keywords
hypercapnic respiratory failure, COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hemolung Respiratory Assist System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Hemolung Respiratory Assist System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of occurrence of serious adverse events while on Hemolung therapy and up to 30 days after cessation of therapy and decannulation.
Time Frame
30 days
Title
Percentage of patients requiring Mechanical Ventilation
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Improvement in patient self assessment of dyspnea using visual analog scale pre- to post-Hemolung therapy.
Time Frame
7 days
Title
Change in Minute Volume (VE) pre- to end-Hemolung therapy
Time Frame
7 days
Title
Number of days in the ICU
Time Frame
30 days
Title
Number of days in the hospital
Time Frame
30 days
Title
Number of days alive and off mechanical ventilation for > 48 hours through the end of Day 30 following completion of Hemolung therapy
Time Frame
30 days
Title
Percentage of patients requiring sedation, and hours of sedation
Time Frame
30 days
Title
Number of days on Non-Invasive Positive Pressure Ventilation (NIPPV)
Time Frame
30 days
Title
For patients requiring Mechanical Ventilation, number of days on Mechanical Ventilation
Time Frame
30 days
Title
Duration of weaning time from NIPPV
Time Frame
7 days
Title
Duration of weaning time from Hemolung therapy
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RK Mani, MD
Organizational Affiliation
Artemis Health Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Artemis Health Institute
City
Gurgaon
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
12. IPD Sharing Statement
Citations:
PubMed Identifier
23460154
Citation
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.
Results Reference
derived
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Feasibility Study of the Hemolung Respiratory Assist System
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