Comparative Study of 3 Portable Oxygen Concentrators During a 6-minute Walk Test in Patients With Chronic Lung Disease
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Obstructive Lung Disease Pulmonary Fibrosis |
Device: Eclipse 3 portable oxygen concentrator Device: EverGo portable oxygen concentrator Device: iGo portable oxygen concentrator |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Supportive Care |
| 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 |
- 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 ] [ Designated as safety issue: Yes ]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.
- Total distance walked [ Time Frame: During study session 2: immediately after finishing (post-) each of four 6-minute walk tests ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]Measured with the modified 10-point Borg scale
- Patient preference ratings [ Time Frame: During study session 2: immediately after finishing (post-) each of four 6-minute walk tests ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 24 |
| Study Start Date: | February 2010 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Eclipse 3 portable oxygen concentrator
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.
|
Device: Eclipse 3 portable oxygen concentrator
Other Name: Eclipse 3 (SeQual Technologies, San Diego, CA, USA)
|
|
Experimental: iGo portable oxygen concentrator
Use of the iGo portable oxygen concentrator set at maximum pulse-dose setting 10-minutes prior to, and during a 6-minute walk test.
|
Device: iGo portable oxygen concentrator
Other Name: iGo (DeVillbiss Healthcare, Summerset, PA, USA)
|
|
Experimental: EverGo portable oxygen concentrator
Use of the iGo portable oxygen concentrator set at maximum pulse-dose setting 10-minutes prior to, and during a 6-minute walk test.
|
Device: EverGo portable oxygen concentrator
Other Name: EverGo (Respironics Inc., Murrysville, PA, USA)
|
|
No Intervention: Control portable oxygen concentrator
6-minute walk test completed using each patient's own oxygen delivery system set at their usual oxygen prescription for exercise
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Contacts and Locations| Canada, Ontario | |
| The Ottawa Hospital Rehabilitation Centre | |
| Ottawa, Ontario, Canada, K1H 8M2 | |
| Principal Investigator: | Lyne Lavallée, BSc(PT) | The Ottawa Hospital Rehabilitation Centre |
| Principal Investigator: | Carole Leblanc, RRT | The Ottawa Hospital Rehabilitation Centre |
| Principal Investigator: | Doug McKim, MD | The Ottawa Hospital |
More Information
No publications provided
| Responsible Party: | Ottawa Hospital Research Institute |
| ClinicalTrials.gov Identifier: | NCT01653730 History of Changes |
| Other Study ID Numbers: | POC-325 |
| Study First Received: | July 16, 2012 |
| Last Updated: | July 27, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Ottawa Hospital Research Institute:
|
portable oxygen concentrator 6-minute walk test chronic obstructive lung disease pulmonary fibrosis long term oxygen therapy |
Additional relevant MeSH terms:
|
Fibrosis Lung Diseases Pulmonary Disease, Chronic Obstructive Pulmonary Fibrosis |
Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on June 18, 2013