Chronic Obstructive Lung DiseaseNCT01653730
Comparative Study of 3 Portable Oxygen Concentrators During a 6-minute Walk Test in Patients With Chronic Lung Disease
A study testing Eclipse 3 portable oxygen concentrator, EverGo portable oxygen concentrator and iGo portable oxygen concentrator in people with Chronic Obstructive Lung Disease and Pulmonary Fibrosis, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Background: Portable oxygen concentrators (POCs) featuring the latest integrated oxygen conserving devices (OCDs) provide greater patient accessibility and mobility during ambulation and travel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Lung Disease, Pulmonary Fibrosis
- What is being tested?
- Eclipse 3 portable oxygen concentrator, EverGo portable oxygen concentrator and iGo portable oxygen concentrator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2010to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Existing diagnosis of chronic obstructive lung disease or pulmonary fibrosis
- completed the pulmonary rehabilitation program at The Ottawa Hospital Rehabilitation Centre between January 30th 2008 and March 31st 2011
- medically stable
- medical prescription for long term oxygen therapy
- 18 years or older
Who cannot join
- non-ambulatory
- not independent for activities of daily living
- not active in the community
- show limited improvement with any level of continuous oxygen flow rate
- require more than 6 litres per minute of oxygen on continuous flow during exertion
- experienced an exacerbation of their respiratory medical condition over the last 6 weeks, or have not fully recovered from a recent exacerbation
Show all 12Show fewer
- have moderate to severe orthopaedic or neurological conditions limiting their ability to walk
- have any other impairments that could affect the consistency of the 6-minute walk test
- have severe co-morbid conditions
- are limited by their cardiac condition or have been diagnosed with a cardiac condition since completion of their pulmonary rehabilitation
- severe cognitive or memory deficit
- speak neither French nor English
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Ottawa Hospital Rehabilitation Centre
Ottawa, Ontario, K1H 8M2
About this study
Official title: A Comparative Pilot Study of the Efficacy of Three Portable Oxygen Concentrators During a 6-Minute Walk Test in Patients With Chronic Lung Disease
Background: Portable oxygen concentrators (POCs) featuring the latest integrated oxygen conserving devices (OCDs) provide greater patient accessibility and mobility during ambulation and travel. Recent POCs are compact, lightweight, battery-operated, and require no refill-time, thus meeting patients' clinical and lifestyle needs. There is, however, a lack of research on the clinical performance of the latest POCs that could help to determine their ability to maintain patients' oxygen saturations ≥ 90 % during exercise.
Aim: The purpose of this study is to compare the ability of three POCs, with maximum oxygen production capabilities of 950 to 3000 ml per minute, to maintain oxygen saturations ≥ 90 % in patients with chronic lung disease during exercise.
Read more
Method: Six minute walk tests (6-MWTs) will be administered in order to measure oxygen saturations by pulse oximetry (SpO2) in up to 20 patients with a diagnosis of either Chronic Obstructive Pulmonary Disease (COPD), or Pulmonary Fibrosis (PF) with documented exertional oxygen desaturations of ≤ 85% on room air. All participants will participate in 4 different 6-minute walk tests: the first will be a control walk performed with the participants' current oxygen system set at their prescribed exertional flow rate. Then, the participants will perform a walk test with each of the three POCs set at the units' maximum pulse dose setting. The order in which the participants use the POCs will be randomly assigned using a sequence generator.
Hypothesis: It is hypothesized that all three POCs will provide oxygen saturations ≥ 90 % during exercise in patients with chronic lung disease with moderate to severe exertional oxygen desaturation.
Read the detailed description
Participants will attend two study sessions. During the session 1 participants will perform a 6-minute walk test on room air oxygen to assess their suitability for the study. Only those participants with documented exertional oxygen desaturations of ≤ 85% as measured by pulse oximetry during this walk will be asked to return for the second session. During session 2 participants will perform a further four 6-minute walk tests spread over a morning and afternoon testing session. All all data for primary and secondary outcomes will be measured at session 2.
- Being tested
- Eclipse 3 portable oxygen concentrator, EverGo portable oxygen concentrator, iGo portable oxygen concentrator
- Keywords
- portable oxygen concentrator, 6-minute walk test, chronic obstructive lung disease, pulmonary fibrosis, long term oxygen therapy
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eclipse 3 portable oxygen concentratorDevice
Also called Eclipse 3 (SeQual Technologies, San Diego, CA, USA)
EverGo portable oxygen concentratorDevice
Also called EverGo (Respironics Inc., Murrysville, PA, USA)
iGo portable oxygen concentratorDevice
Also called iGo (DeVillbiss Healthcare, Summerset, PA, USA)
| Study group | Role | What they receive |
|---|---|---|
| Eclipse 3 portable oxygen concentrator | Experimental | Use of the Eclipse 3 portable oxygen concentrator set at maximum pulse-dose setting 10-minutes prior to, and during a 6-minute walk test. Receives: Device: Eclipse 3 portable oxygen concentrator |
| iGo portable oxygen concentrator | Experimental | Use of the iGo portable oxygen concentrator set at maximum pulse-dose setting 10-minutes prior to, and during a 6-minute walk test. Receives: Device: iGo portable oxygen concentrator |
| EverGo portable oxygen concentrator | Experimental | Use of the iGo portable oxygen concentrator set at maximum pulse-dose setting 10-minutes prior to, and during a 6-minute walk test. Receives: Device: EverGo portable oxygen concentrator |
| Control portable oxygen concentrator | No intervention | 6-minute walk test completed using each patient's own oxygen delivery system set at their usual oxygen prescription for exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in saturation of oxygen in the blood after a 6-minute walk test
For patient safety oxygen saturation was monitored throughout each 6-minute walk test using pulse oximetry. Pre- and post-walk values were captured as the primary outcome measure.
Measured: During study session 2: immediately before beginning (pre-) and immediately after finishing (post-) each of four 6-minute walk tests
Secondary outcomes (4)
Total distance walked
Measured: During study session 2: immediately after finishing (post-) each of four 6-minute walk tests
Change in Dyspnea ratings after a 6-minute walk test
Measured with the modified 10-point Borg scale
Measured: During study session 2: immediately before beginning (pre-) and immediately after finishing (post-) each of four 6-minute walk tests
Patient preference ratings
Measured using a self-report questionnaire where patients were asked to indicate how much they agreed with statements about the device they had just used.
Measured: During study session 2: immediately after finishing (post-) each of four 6-minute walk tests
Walk time spent with oxygen saturation greater than or equal to 90%
Measured: During study session 2: immediately after finishing (post-) each of four 6-minute walk tests
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startFeb 2010
- Primary completionAug 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 Chronic Obstructive Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Institute for Rehabilitation Research and Development, The Ottawa Hospital Rehabilitation Centre
- Responsible party
- Sponsor
- Investigators
- Lyne Lavallée, BSc(PT), Principal investigator, The Ottawa Hospital Rehabilitation CentreCarole Leblanc, RRT, Principal investigator, The Ottawa Hospital Rehabilitation CentreDoug McKim, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01653730
- Sponsor's protocol ID
- POC-325
- Status last verified
- Jul 2012
- First submitted
- 16 Jul 2012
- Last updated
- 31 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Leblanc CJ, Lavallee LG, King JA, Taylor-Sussex RE, Woolnough A, McKim DA. A comparative study of 3 portable oxygen concentrators during a 6-minute walk test in patients with chronic lung disease. Respir Care. 2013 Oct;58(10):1598-605. doi: 10.4187/respcare.02275. Epub 2013 Apr 2.
PubMed 23550171
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Pilot Study of the Efficacy of Three Portable Oxygen Concentrators During a 6-Minute Walk Test in Patients With Chronic Lung Disease
- ClinicalTrials.gov ID
- NCT01653730
- Acronym / sponsor ID
- POC-325
- Keywords
- portable oxygen concentrator, 6-minute walk test, chronic obstructive lung disease, pulmonary fibrosis, long term oxygen therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Institute for Rehabilitation Research and Development, The Ottawa Hospital Rehabilitation Centre
- Study start
- Feb 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 31 Jul 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.
Background: Portable oxygen concentrators (POCs) featuring the latest integrated oxygen conserving devices (OCDs) provide greater patient accessibility and mobility during ambulation and travel. Recent POCs are compact, lightweight, battery-operated, and require no refill-time, thus meeting patients' clinical and lifestyle needs. There is, however, a lack of research on the clinical performance of the latest POCs that could help to determine their ability to maintain patients' oxygen saturations ≥ 90 % during exercise.
Aim: The purpose of this study is to compare the ability of three POCs, with maximum oxygen production capabilities of 950 to 3000 ml per minute, to maintain oxygen saturations ≥ 90 % in patients with chronic lung disease during exercise.
Method: Six minute walk tests (6-MWTs) will be administered in order to measure oxygen saturations by pulse oximetry (SpO2) in up to 20 patients with a diagnosis of either Chronic Obstructive Pulmonary Disease (COPD), or Pulmonary Fibrosis (PF) with documented exertional oxygen desaturations of ≤ 85% on room air. All participants will participate in 4 different 6-minute walk tests: the first will be a control walk performed with the participants' current oxygen system set at their prescribed exertional flow rate. Then, the participants will perform a walk test with each of the three POCs set at the units' maximum pulse dose setting. The order in which the participants use the POCs will be randomly assigned using a sequence generator.
Hypothesis: It is hypothesized that all three POCs will provide oxygen saturations ≥ 90 % during exercise in patients with chronic lung disease with moderate to severe exertional oxygen desaturation.
Detailed description
Participants will attend two study sessions. During the session 1 participants will perform a 6-minute walk test on room air oxygen to assess their suitability for the study. Only those participants with documented exertional oxygen desaturations of ≤ 85% as measured by pulse oximetry during this walk will be asked to return for the second session. During session 2 participants will perform a further four 6-minute walk tests spread over a morning and afternoon testing session. All all data for primary and secondary outcomes will be measured at session 2.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Eclipse 3 portable oxygen concentrator | Experimental | Device: Eclipse 3 portable oxygen concentratorUse of the Eclipse 3 portable oxygen concentrator set at maximum pulse-dose setting 10-minutes prior to, and during a 6-minute walk test. |
| iGo portable oxygen concentrator | Experimental | Device: iGo portable oxygen concentratorUse of the iGo portable oxygen concentrator set at maximum pulse-dose setting 10-minutes prior to, and during a 6-minute walk test. |
| EverGo portable oxygen concentrator | Experimental | Device: EverGo portable oxygen concentratorUse of the iGo portable oxygen concentrator set at maximum pulse-dose setting 10-minutes prior to, and during a 6-minute walk test. |
| Control portable oxygen concentrator | No intervention | –6-minute walk test completed using each patient's own oxygen delivery system set at their usual oxygen prescription for exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Existing diagnosis of chronic obstructive lung disease or pulmonary fibrosis
- completed the pulmonary rehabilitation program at The Ottawa Hospital Rehabilitation Centre between January 30th 2008 and March 31st 2011
- medically stable
- medical prescription for long term oxygen therapy
- 18 years or older
Key exclusion criteria (12 listed)
- non-ambulatory
- not independent for activities of daily living
- not active in the community
- show limited improvement with any level of continuous oxygen flow rate
- require more than 6 litres per minute of oxygen on continuous flow during exertion
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 |
|---|---|---|
| Eclipse 3 portable oxygen concentratorAlso: Eclipse 3 (SeQual Technologies, San Diego, CA, USA) | Device | Eclipse 3 portable oxygen concentrator |
| EverGo portable oxygen concentratorAlso: EverGo (Respironics Inc., Murrysville, PA, USA) | Device | EverGo portable oxygen concentrator |
| iGo portable oxygen concentratorAlso: iGo (DeVillbiss Healthcare, Summerset, PA, USA) | Device | iGo portable oxygen concentrator |
Primary outcome
Change in saturation of oxygen in the blood after a 6-minute walk test
Time frame: During study session 2: immediately before beginning (pre-) and immediately after finishing (post-) each of four 6-minute walk tests
For patient safety oxygen saturation was monitored throughout each 6-minute walk test using pulse oximetry. Pre- and post-walk values were captured as the primary outcome measure.
4 secondary outcomes
Total distance walked
Time frame: During study session 2: immediately after finishing (post-) each of four 6-minute walk tests
Change in Dyspnea ratings after a 6-minute walk test
Time frame: During study session 2: immediately before beginning (pre-) and immediately after finishing (post-) each of four 6-minute walk tests
Patient preference ratings
Time frame: During study session 2: immediately after finishing (post-) each of four 6-minute walk tests
Walk time spent with oxygen saturation greater than or equal to 90%
Time frame: During study session 2: immediately after finishing (post-) each of four 6-minute walk tests
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 31 Jul 2012.
- Derived from this study: PubMed 23550171Leblanc CJ, Lavallee LG, King JA, Taylor-Sussex RE, Woolnough A, McKim DA. A comparative study of 3 portable oxygen concentrators during a 6-minute walk test in patients with chronic lung disease. Respir Care. 2013 Oct;58(10):1598-605. doi: 10.4187/respcare.02275. Epub 2013 Apr 2.
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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.
Lyne Lavallée, BSc(PT) principal investigator
The Ottawa Hospital Rehabilitation Centre
Carole Leblanc, RRT principal investigator
The Ottawa Hospital Rehabilitation Centre
Doug McKim, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Eclipse 3 portable oxygen concentrator, EverGo portable oxygen concentrator and iGo portable oxygen concentrator in people with Chronic Obstructive Lung Disease and Pulmonary Fibrosis, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 5 inclusion and 12 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 31 Jul 2012. 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 Canada. 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?
Change in saturation of oxygen in the blood after a 6-minute walk test (time frame: During study session 2: immediately before beginning (pre-) and immediately after finishing (post-) each of four 6-minute walk tests). 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 NCT01653730, 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 31 Jul 2012.