Hypercapnic Respiratory Failure, COPD, ARDSNCT01021605
Feasibility Study of the Hemolung Respiratory Assist System (Germany)
A study testing Hemolung Respiratory Assist System in people with Hypercapnic Respiratory Failure, COPD, ARDS, run by Alung Technologies at 7 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Hypercapnic Respiratory Failure, COPD, ARDS
- What is being tested?
- Hemolung Respiratory Assist System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 7 sitesGermany
- Study dates
- Dec 2009to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Germany7 sites
Universitätsklinikum Bonn
Bonn
Klinik Donaustauf
Donaustauf, 93093
Ruhrlandklinik Das Lungenzentrum Essen-Heidhausen Abt.: Pneumologie
Essen, North Rhine-Westphalia, 45122
Universitätsmedizin Göttingen
Göttingen, D-37077
Asklepios Klinik Barmbek
Hamburg, 22291
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69126
Krankenhaus Bethanien
Solingen, 42699
About this study
Official title: A Prospective, Non-Randomized Feasibility Study of the Hemolung Respiratory Assist System in Patients With Acute Hypercapnic Respiratory Failure
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.
Read the 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.
- Being tested
- Hemolung Respiratory Assist System
- Keywords
- hypercapnic respiratory failure, COPD, ARDS
- Medical subject headings
- Respiratory Insufficiency, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hemolung Respiratory Assist SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Hemolung Respiratory Assist System | Experimental | Not described Receives: Device: Hemolung Respiratory Assist System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 7 days
The frequency of occurrence of serious adverse events while on Hemolung therapy and up to 30 days from completion of Hemolung therapy.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypercapnic Respiratory Failure, COPD, ARDSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alung Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felix JF Herth, MD, Principal investigator, Thoraxklinik-Heidelberg gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021605
- Sponsor's protocol ID
- HL-CA-1000
- Status last verified
- Sep 2019
- First submitted
- 25 Nov 2009
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23460154
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Randomized Feasibility Study of the Hemolung Respiratory Assist System in Patients With Acute Hypercapnic Respiratory Failure
- ClinicalTrials.gov ID
- NCT01021605
- Acronym / sponsor ID
- HL-CA-1000
- Keywords
- hypercapnic respiratory failure, COPD, ARDS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Alung TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 30 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemolung Respiratory Assist System | Experimental | Device: Hemolung Respiratory Assist System |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hemolung Respiratory Assist SystemPatients 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. | Device | Hemolung Respiratory Assist System |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Derived from this study: PubMed 23460154Burki 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Felix JF Herth, MD principal investigator
Thoraxklinik-Heidelberg gGmbH
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemolung Respiratory Assist System in people with Hypercapnic Respiratory Failure, COPD, ARDS, run by Alung Technologies at 7 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01021605, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.