COPDNCT01713413
Effects of an Oxymizer on Endurance Time in Patients With Chronic Lung Diseases
A study testing Oxymizer and conventional nasal cannula in people with COPD and Interstitial Lung Disease, run by Schön Klinik Berchtesgadener Land at 1 site in Germany.
Trial summary
The Oxymizer pendant® is a special oxygen cannula that can be used to supply high flow long term oxygen therapy. It is compatible with a wide variety of oxygen sources. In a reservoir, the Oxymizer® stores pure oxygen so that the concentration of inhaled oxygen is increased. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COPD, Interstitial Lung Disease
- What is being tested?
- Oxymizer and conventional nasal cannula
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to Mar 2014
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD IV
- interstitial lung disease
- long-term oxygen therapy with oxygen flow rate >= 2 L/min
Who cannot join
- acute cardial decompensation
- usual kontraindication for exposure test (higher-grad Hypertension (arterial and pulmonal), cardiac valve vitien, instabile angina pectoris, cardiac arrhythmia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of an Oxymizer Versus Conventional Nasal Cannula on Endurance Time in Patients With Chronic Obstructive Pulmonary Disease IV (COPD) or Interstitial Lung Disease (ILD)
The Oxymizer pendant® is a special oxygen cannula that can be used to supply high flow long term oxygen therapy. It is compatible with a wide variety of oxygen sources. In a reservoir, the Oxymizer® stores pure oxygen so that the concentration of inhaled oxygen is increased.
The aim of this study is to investigate the potential benefit of the Oxymizer® with regard to the blood oxygenation during exercise testing. Given that the "endurance time" is very sensitive for little changes in exercise capacity, this test will be used to show the difference between the Oxymizer® and a conventional nasal cannula regarding exercise duration at 70% of peak Watt and oxygenation.
The tests will be accompanied by blood gas analysis, partial pressure of carbon dioxide and heart rate.
- Conditions
- COPD, Interstitial Lung Disease
- Being tested
- Oxymizer, conventional nasal cannula
- Keywords
- Oxymizer, endurance time, exercise test, nasal cannula, COPD, ILD, oxygenation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxymizerDevice
Using first the Oxymizer and 24 h later the conventional nasal cannula.
conventional nasal cannulaDevice
Using first the conventional nasal cannula and 24h later the Oxymizer
| Study group | Role | What they receive |
|---|---|---|
| Oxymizer | Active comparator | Using first the Oxymizer and 24 h later the conventional nasal cannula. Receives: Device: Oxymizer |
| nasal cannula | Active comparator | Using first the conventional nasal cannula and 24 h later the Oxymizer Receives: Device: conventional nasal cannula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between Endurance time with Oxymizer and conventional nasal cannula
Measured: From starting until stopping cycling, up to 60 minutes
Secondary outcomes (2)
Difference in oxygen saturation with Oxymizer and with conventional nasal cannula
Measured: stopping cycling, up to 60 minutes
Difference in PaCO2 with Oxymizer and with conventional nasal cannula
measured by Sentec device
Measured: Stopping cycling, up to 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2012 (estimated)
- Study startFeb 2012
- Primary completionFeb 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Schön Klinik Berchtesgadener Land
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klaus Kenn, Schön Klinik Berchtesgadener Land
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713413
- Sponsor's protocol ID
- OXYM2012
- Status last verified
- Apr 2014
- First submitted
- 24 Feb 2012
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Oxymizer Versus Conventional Nasal Cannula on Endurance Time in Patients With Chronic Obstructive Pulmonary Disease IV (COPD) or Interstitial Lung Disease (ILD)
- ClinicalTrials.gov ID
- NCT01713413
- Acronym / sponsor ID
- OXYM2012
- Conditions
- COPD, Interstitial Lung Disease
- Keywords
- Oxymizer, endurance time, exercise test, nasal cannula, COPD, ILD, oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Schön Klinik Berchtesgadener LandUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 24 Oct 2012 (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 Oxymizer pendant® is a special oxygen cannula that can be used to supply high flow long term oxygen therapy. It is compatible with a wide variety of oxygen sources. In a reservoir, the Oxymizer® stores pure oxygen so that the concentration of inhaled oxygen is increased.
The aim of this study is to investigate the potential benefit of the Oxymizer® with regard to the blood oxygenation during exercise testing. Given that the "endurance time" is very sensitive for little changes in exercise capacity, this test will be used to show the difference between the Oxymizer® and a conventional nasal cannula regarding exercise duration at 70% of peak Watt and oxygenation.
The tests will be accompanied by blood gas analysis, partial pressure of carbon dioxide and heart rate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxymizer | Active comparator | Device: OxymizerUsing first the Oxymizer and 24 h later the conventional nasal cannula. |
| nasal cannula | Active comparator | Device: conventional nasal cannulaUsing first the conventional nasal cannula and 24 h later the Oxymizer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- COPD IV
- interstitial lung disease
- long-term oxygen therapy with oxygen flow rate >= 2 L/min
Key exclusion criteria (2 listed)
- acute cardial decompensation
- usual kontraindication for exposure test (higher-grad Hypertension (arterial and pulmonal), cardiac valve vitien, instabile angina pectoris, cardiac arrhythmia)
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 |
|---|---|---|
| OxymizerUsing first the Oxymizer and 24 h later the conventional nasal cannula. | Device | Oxymizer |
| conventional nasal cannulaUsing first the conventional nasal cannula and 24h later the Oxymizer | Device | nasal cannula |
Primary outcome
Difference between Endurance time with Oxymizer and conventional nasal cannula
Time frame: From starting until stopping cycling, up to 60 minutes
2 secondary outcomes
Difference in oxygen saturation with Oxymizer and with conventional nasal cannula
Time frame: stopping cycling, up to 60 minutes
Difference in PaCO2 with Oxymizer and with conventional nasal cannula
Time frame: Stopping cycling, up to 60 minutes
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 15 Apr 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxymizer and conventional nasal cannula in people with COPD and Interstitial Lung Disease, run by Schön Klinik Berchtesgadener Land at 1 site 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 3 inclusion and 2 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 15 Apr 2014. 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 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?
Difference between Endurance time with Oxymizer and conventional nasal cannula (time frame: From starting until stopping cycling, up to 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2014.