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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
Alung Technologies
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercapnic Respiratory Failure, COPD focused on measuring hypercapnic respiratory failure, COPD

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 30, 2009
Last Updated
August 9, 2017
Sponsor
Alung Technologies
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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
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Feasibility Study of the Hemolung Respiratory Assist System

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