To Determine the Efficacy of Two Liquid Oxygen DeviceNCT01086891
Efficacy of Two Liquid Oxygen Devices in Deambulation
A study testing Oxygen conserving devices in people with To Determine the Efficacy of Two Liquid Oxygen Device, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
Trial summary
Some oxygen conserving devices have been developed to diminish oxygen expense. These devices offer optimisation of oxygen therapy for deambulation by improving time autonomy of patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- To Determine the Efficacy of Two Liquid Oxygen Device
- What is being tested?
- Oxygen conserving devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Apr 2008to Feb 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with arterial oxygen desaturation to effort.
- COPD with TLC > 90%
- EPID with TLC < 90% and FEV1/FVC > 70%
Who cannot join
- Patients with long-term oxygen therapy (LTOT) in deambulation.
- Not clinically stable during last month.
- Smokers
Trial locations and contacts
1 site in 1 country.
Spain1 site
Fundacio Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, 08025
About this study
Some oxygen conserving devices have been developed to diminish oxygen expense. These devices offer optimisation of oxygen therapy for deambulation by improving time autonomy of patients.
- Being tested
- Oxygen conserving devices
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxygen conserving devicesDevice
Also called Oxygen conserving devices in COPD.
Three 6MWT test will be performed at random with conventional oxygen continuous-flow,by Oxymizer Pendant and demand valve system. The percentage of patients correcting their desaturation and patients' acceptance of every method will be determinated.
Oxygen conserving devicesDevice
Also called Oxygen conserving devices in interstitial lung disease.
Three 6MWT test will be performed at random with conventional oxygen continuous-flow,by Oxymizer Pendant and demand valve system. The percentage of patients correcting their desaturation and patients' acceptance of every method will be determinated
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Patients with chronic obstructive pulmonary disease who show arterial oxygen desaturation to effort. Receives: Device: Oxygen conserving devices |
| 2 | Experimental | Patients with interstitial lung disease who show arterial oxygen desaturation to effort Receives: Device: Oxygen conserving devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the efficacy of correcting desaturation during effort and the acceptance of two different oxygen conserving devices during deambulation,one system with reservoir an another one with oxygen demand valve.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2010 (estimated)
- Study startApr 2008
- Primary completionJan 2010
- Study completionFeb 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 To Determine the Efficacy of Two Liquid Oxygen DeviceStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergi Marti, Doctor, Principal investigator, H.Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01086891
- Sponsor's protocol ID
- 07/060/793
- Status last verified
- May 2012
- First submitted
- 3 Feb 2010
- Last updated
- 30 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Marti S, Pajares V, Morante F, Ramon MA, Lara J, Ferrer J, Guell MR. Are oxygen-conserving devices effective for correcting exercise hypoxemia? Respir Care. 2013 Oct;58(10):1606-13. doi: 10.4187/respcare.02260. Epub 2013 Mar 19.
PubMed 23513249
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Two Liquid Oxygen Devices in Deambulation
- ClinicalTrials.gov ID
- NCT01086891
- Acronym / sponsor ID
- 07/060/793
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jan 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 15 Mar 2010 (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.
Some oxygen conserving devices have been developed to diminish oxygen expense. These devices offer optimisation of oxygen therapy for deambulation by improving time autonomy of patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Oxygen conserving devicesPatients with chronic obstructive pulmonary disease who show arterial oxygen desaturation to effort. |
| 2 | Experimental | Device: Oxygen conserving devicesPatients with interstitial lung disease who show arterial oxygen desaturation to effort |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with arterial oxygen desaturation to effort.
- COPD with TLC > 90%
- EPID with TLC < 90% and FEV1/FVC > 70%
Key exclusion criteria (3 listed)
- Patients with long-term oxygen therapy (LTOT) in deambulation.
- Not clinically stable during last month.
- Smokers
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 |
|---|---|---|
| Oxygen conserving devicesAlso: Oxygen conserving devices in COPD.Three 6MWT test will be performed at random with conventional oxygen continuous-flow,by Oxymizer Pendant and demand valve system. The percentage of patients correcting their desaturation and patients' acceptance of every method will be determinated. | Device | 1 |
| Oxygen conserving devicesAlso: Oxygen conserving devices in interstitial lung disease.Three 6MWT test will be performed at random with conventional oxygen continuous-flow,by Oxymizer Pendant and demand valve system. The percentage of patients correcting their desaturation and patients' acceptance of every method will be determinated | Device | 2 |
Primary outcome
To determine the efficacy of correcting desaturation during effort and the acceptance of two different oxygen conserving devices during deambulation,one system with reservoir an another one with oxygen demand valve.
Time frame: 2 years
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 Aug 2013.
- Derived from this study: PubMed 23513249Marti S, Pajares V, Morante F, Ramon MA, Lara J, Ferrer J, Guell MR. Are oxygen-conserving devices effective for correcting exercise hypoxemia? Respir Care. 2013 Oct;58(10):1606-13. doi: 10.4187/respcare.02260. Epub 2013 Mar 19.
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.
Sergi Marti, Doctor principal investigator
H.Vall d'Hebron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxygen conserving devices in people with To Determine the Efficacy of Two Liquid Oxygen Device, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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 3 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 Aug 2013. 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 Spain. 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?
To determine the efficacy of correcting desaturation during effort and the acceptance of two different oxygen conserving devices during deambulation,one system with reservoir an another one with oxygen demand valve. (time frame: 2 years). 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 NCT01086891, 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 Aug 2013.