Clinical trial NCT01653730: Comparative Study of 3 Portable Oxygen Concentrators During a 6-minute Walk Test in Patients With Chronic Lung Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Lung Disease
Pulmonary Fibrosis
Keywords: portable oxygen concentrator
6-minute walk test
chronic obstructive lung disease
pulmonary fibrosis
long term oxygen therapy
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Institute for Rehabilitation Research and Development, The Ottawa Hospital Rehabilitation Centre
First posted: 2012-07-31
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in saturation of oxygen in the blood after a 6-minute walk test
timeFrame: During study session 2: immediately before beginning (pre-) and immediately after finishing (post-) each of four 6-minute walk tests
Secondary outcomes:
measure: Total distance walked
timeFrame: During study session 2: immediately after finishing (post-) each of four 6-minute walk tests
measure: Change in Dyspnea ratings after a 6-minute walk test
timeFrame: During study session 2: immediately before beginning (pre-) and immediately after finishing (post-) each of four 6-minute walk tests
measure: Patient preference ratings
timeFrame: During study session 2: immediately after finishing (post-) each of four 6-minute walk tests
measure: Walk time spent with oxygen saturation greater than or equal to 90%
timeFrame: During study session 2: immediately after finishing (post-) each of four 6-minute walk tests
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital Rehabilitation Centre
state: Ontario
Study officials:
affiliation: The Ottawa Hospital Rehabilitation Centre
name: Lyne Lavallée, BSc(PT)
role: PRINCIPAL_INVESTIGATOR
affiliation: The Ottawa Hospital Rehabilitation Centre
name: Carole Leblanc, RRT
role: PRINCIPAL_INVESTIGATOR
affiliation: The Ottawa Hospital
name: Doug McKim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.