Feasibility Study of the Hemolung Respiratory Assist System (Germany)
Primary Purpose
Hypercapnic Respiratory Failure, COPD, ARDS
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Hemolung Respiratory Assist System
Sponsored by
About this trial
This is an interventional treatment trial for Hypercapnic Respiratory Failure, COPD, ARDS focused on measuring hypercapnic respiratory failure, COPD, ARDS
Eligibility Criteria
Inclusion Criteria:
- Diagnosed hypercapnic respiratory failure (PaCO2 >50mmHg(6.7kPa)) and falling into one of the five groups
- Not severely hypoxemic (PaO2/FiO2 ≥ 200 mmHg on PEEP/CPAP ≤ 5 cmH2O)
- Hemodynamically stable: Mean arterial pressure (MAP) > 65 mmHg without vasopressor support, or MAP > 60 mmHg with a requirement for vasopressor support that can be attributed to sedation or dynamic hyperinflation resulting from mechanical ventilation by the treating investigator.
- 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
Group 1:
- Known or suspected severe COPD, as defined by the GOLD criteria
- 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
Group 2:
- Intubated or tracheostomized patients with hypercapnic respiratory failure who either:
- Has failed at least 2 weaning attempts or
- Has failed at least 1 attempt and wishes not to be invasively mechanically ventilated
Group 3:
- Patient on NIPPV due to hypercapnic respiratory failure who has failed at least 2 weaning attempts and has refused intubation
Group 4:
- Patients with hypercapnic respiratory failure who are failing optimal NIPPV or demonstrate a complete intolerance to NIPPV and IMV is considered undesirable
Group 5:
- Patients who are on IMV and would benefit from the application of lung protective ventilation, and in whom this would not be achieved without significant worsening of respiratory failure
- On IMV for at least 12 hours
- pH <7.30 due to respiratory acidosis
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 which would complicate or prevent successful insertion of the vascular access catheter in either the right internal jugular vein or right femoral vein
- Presence of another catheter in both the right internal jugular vein and right femoral vein that cannot be moved to allow insertion of the Hemolung catheter in one of these vessels.
Sites / Locations
- Thoraxklinik am Universitätsklinikum Heidelberg
- Ruhrlandklinik Das Lungenzentrum Essen-Heidhausen Abt.: Pneumologie
- Universitätsklinikum Bonn
- Klinik Donaustauf
- Universitätsmedizin Göttingen
- Asklepios Klinik Barmbek
- Krankenhaus Bethanien
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hemolung Respiratory Assist System
Arm Description
Outcomes
Primary Outcome Measures
The ability of the Hemolung to remove a minimum of 50 mL/min of CO2 for up to seven days and reliable performance of the device over the length of use
The frequency of occurrence of serious adverse events while on Hemolung therapy and up to 30 days from completion of Hemolung therapy.
Secondary Outcome Measures
Full Information
NCT ID
NCT01021605
First Posted
November 25, 2009
Last Updated
September 27, 2019
Sponsor
Alung Technologies
1. Study Identification
Unique Protocol Identification Number
NCT01021605
Brief Title
Feasibility Study of the Hemolung Respiratory Assist System (Germany)
Official Title
A Prospective, Non-Randomized Feasibility Study of the Hemolung Respiratory Assist System in Patients With Acute Hypercapnic Respiratory Failure
Study Type
Interventional
2. Study Status
Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (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
No
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 (RAS) in patients with hypercapnic respiratory failure.
Detailed Description
The objective of the feasibility study is to evaluate the safety and efficacy of the Hemolung RAS in patients with hypercapnic respiratory failure in five groups of patients:
Group 1: COPD patients with an acute exacerbation and have a 50% likelihood of failure of noninvasive positive pressure ventilation (NIPPV) leading to intubation and mechanical ventilation
Group 2: Patients with hypercapnic respiratory failure on invasive mechanical ventilation who have either:
Failed two or more weaning attempts OR
Failed one or more weaning attempts and do not wish to be invasively mechanically ventilated.
Group 3: Patients with hypercapnic respiratory failure on noninvasive positive pressure ventilation who have failed two weaning attempts and do not wish to be invasively mechanically ventilated.
Group 4: Patients with hypercapnic respiratory failure who in the view of the treating physician are declining on optimized non-invasive positive pressure ventilation OR demonstrate a complete intolerance of non-invasive positive pressure ventilation for any reason and invasive mechanical ventilation is considered undesirable by the treating physician.
Group 5: Patients who are currently invasively mechanically ventilated and in the view of the treating physician would benefit from the application of protective lung ventilation, and in whom this cannot be achieved without significant worsening of respiratory failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercapnic Respiratory Failure, COPD, ARDS
Keywords
hypercapnic respiratory failure, COPD, ARDS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (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 or invasive ventilation and then the Hemolung RAS. 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
The ability of the Hemolung to remove a minimum of 50 mL/min of CO2 for up to seven days and reliable performance of the device over the length of use
Time Frame
7 days
Title
The frequency of occurrence of serious adverse events while on Hemolung therapy and up to 30 days from completion of Hemolung therapy.
Time Frame
30 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:
Diagnosed hypercapnic respiratory failure (PaCO2 >50mmHg(6.7kPa)) and falling into one of the five groups
Not severely hypoxemic (PaO2/FiO2 ≥ 200 mmHg on PEEP/CPAP ≤ 5 cmH2O)
Hemodynamically stable: Mean arterial pressure (MAP) > 65 mmHg without vasopressor support, or MAP > 60 mmHg with a requirement for vasopressor support that can be attributed to sedation or dynamic hyperinflation resulting from mechanical ventilation by the treating investigator.
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
Group 1:
Known or suspected severe COPD, as defined by the GOLD criteria
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
Group 2:
Intubated or tracheostomized patients with hypercapnic respiratory failure who either:
Has failed at least 2 weaning attempts or
Has failed at least 1 attempt and wishes not to be invasively mechanically ventilated
Group 3:
Patient on NIPPV due to hypercapnic respiratory failure who has failed at least 2 weaning attempts and has refused intubation
Group 4:
Patients with hypercapnic respiratory failure who are failing optimal NIPPV or demonstrate a complete intolerance to NIPPV and IMV is considered undesirable
Group 5:
Patients who are on IMV and would benefit from the application of lung protective ventilation, and in whom this would not be achieved without significant worsening of respiratory failure
On IMV for at least 12 hours
pH <7.30 due to respiratory acidosis
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 which would complicate or prevent successful insertion of the vascular access catheter in either the right internal jugular vein or right femoral vein
Presence of another catheter in both the right internal jugular vein and right femoral vein that cannot be moved to allow insertion of the Hemolung catheter in one of these vessels.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felix JF Herth, MD
Organizational Affiliation
Thoraxklinik-Heidelberg gGmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thoraxklinik am Universitätsklinikum Heidelberg
City
Heidelberg
State/Province
Baden-Württemberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Ruhrlandklinik Das Lungenzentrum Essen-Heidhausen Abt.: Pneumologie
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitätsklinikum Bonn
City
Bonn
Country
Germany
Facility Name
Klinik Donaustauf
City
Donaustauf
ZIP/Postal Code
93093
Country
Germany
Facility Name
Universitätsmedizin Göttingen
City
Göttingen
ZIP/Postal Code
D-37077
Country
Germany
Facility Name
Asklepios Klinik Barmbek
City
Hamburg
ZIP/Postal Code
22291
Country
Germany
Facility Name
Krankenhaus Bethanien
City
Solingen
ZIP/Postal Code
42699
Country
Germany
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 (Germany)
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