Comparative Study of 3 Portable Oxygen Concentrators During a 6-minute Walk Test in Patients With Chronic Lung Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Comparative Pilot Study of the Efficacy of Three Portable Oxygen Concentrators During a 6-Minute Walk Test in Patients With Chronic Lung Disease

Conditions
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Chronic Obstructive Lung Disease, Pulmonary Fibrosis

Intervention / Treatment
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* Device: Eclipse 3 portable oxygen concentrator
* Device: EverGo portable oxygen concentrator
* Device: iGo portable oxygen concentrator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eclipse 3 portable oxygen concentrator<br>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<br> <br> * Other names: Eclipse 3 (SeQual Technologies, San Diego, CA, USA);|
| Experimental: iGo portable oxygen concentrator<br>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<br> <br> * Other names: iGo (DeVillbiss Healthcare, Summerset, PA, USA);|
| Experimental: EverGo portable oxygen concentrator<br>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<br> <br> * Other names: EverGo (Respironics Inc., Murrysville, PA, USA);|
| No Intervention: Control portable oxygen concentrator<br>6-minute walk test completed using each patient's own oxygen delivery system set at their usual oxygen prescription for exercise | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During study session 2: immediately before beginning (pre-) and immediately after finishing (post-) each of four 6-minute walk tests | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total distance walked |  | 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 | 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. | 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% |  | During study session 2: immediately after finishing (post-) each of four 6-minute walk tests | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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portable oxygen concentrator, 6-minute walk test, chronic obstructive lung disease, pulmonary fibrosis, long term oxygen therapy