Hypercapnic Respiratory Failure, COPDNCT00987740
Feasibility Study of the Hemolung Respiratory Assist System
A study testing Hemolung Respiratory Assist System in people with Hypercapnic Respiratory Failure, COPD, run by Alung Technologies at 1 site in India.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Hypercapnic Respiratory Failure, COPD
- 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
- 2 participants
- Where
- 1 siteIndia
- Study dates
- Oct 2009to Aug 2010
- 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
- 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)
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- 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
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 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
- Conditions
- Hypercapnic Respiratory Failure, COPD
- Being tested
- Hemolung Respiratory Assist System
- Keywords
- hypercapnic respiratory failure, COPD
- 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 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.
| 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.
Frequency of occurrence of serious adverse events while on Hemolung therapy and up to 30 days after cessation of therapy and decannulation.
Measured: 30 days
Percentage of patients requiring Mechanical Ventilation
Measured: 7 days
Secondary outcomes (10)
Improvement in patient self assessment of dyspnea using visual analog scale pre- to post-Hemolung therapy.
Measured: 7 days
Change in Minute Volume (VE) pre- to end-Hemolung therapy
Measured: 7 days
Number of days in the ICU
Measured: 30 days
Number of days in the hospital
Measured: 30 days
Number of days alive and off mechanical ventilation for > 48 hours through the end of Day 30 following completion of Hemolung therapy
Measured: 30 days
Percentage of patients requiring sedation, and hours of sedation
Measured: 30 days
Number of days on Non-Invasive Positive Pressure Ventilation (NIPPV)
Measured: 30 days
For patients requiring Mechanical Ventilation, number of days on Mechanical Ventilation
Measured: 30 days
Duration of weaning time from NIPPV
Measured: 7 days
Duration of weaning time from Hemolung therapy
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionAug 2010
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, COPDStudies 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
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alung Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- RK Mani, MD, Principal investigator, Artemis Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00987740
- Sponsor's protocol ID
- HL-CA-2000
- Status last verified
- Aug 2017
- First submitted
- 30 Sep 2009
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 10 Aug 2017. 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 COPD Patients With Acute Respiratory Failure That Are at a 50% Risk of Failing Non Invasive Ventilation (NIV)
- ClinicalTrials.gov ID
- NCT00987740
- Acronym / sponsor ID
- HL-CA-2000
- Conditions
- Hypercapnic Respiratory Failure, COPD
- Keywords
- hypercapnic respiratory failure, COPD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Alung TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 1 Oct 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 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.
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 (10 listed)
- 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
Key exclusion criteria (21 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 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. | Device | Hemolung Respiratory Assist System |
Primary outcome
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
Percentage of patients requiring Mechanical Ventilation
Time frame: 7 days
10 secondary outcomes
Improvement in patient self assessment of dyspnea using visual analog scale pre- to post-Hemolung therapy.
Time frame: 7 days
Change in Minute Volume (VE) pre- to end-Hemolung therapy
Time frame: 7 days
Number of days in the ICU
Time frame: 30 days
Number of days in the hospital
Time frame: 30 days
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
Percentage of patients requiring sedation, and hours of sedation
Time frame: 30 days
Number of days on Non-Invasive Positive Pressure Ventilation (NIPPV)
Time frame: 30 days
For patients requiring Mechanical Ventilation, number of days on Mechanical Ventilation
Time frame: 30 days
Duration of weaning time from NIPPV
Time frame: 7 days
Duration of weaning time from Hemolung therapy
Time frame: 7 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 10 Aug 2017.
- 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.
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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.
RK Mani, MD principal investigator
Artemis Health Institute
1 site 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, run by Alung Technologies at 1 site in India.
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 10 inclusion and 21 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 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. 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?
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). 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 NCT00987740, 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 10 Aug 2017.