Chronic Obstructive Lung Disease, Pulmonary Fibrosis
Conditions
Keywords
portable oxygen concentrator, 6-minute walk test, chronic obstructive lung disease, pulmonary fibrosis, long term oxygen therapy
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.
Interventions
DEVICEEclipse 3 portable oxygen concentrator
DEVICEEverGo portable oxygen concentrator
DEVICEiGo portable oxygen concentrator
Sponsors
Institute for Rehabilitation Research and Development, The Ottawa Hospital Rehabilitation Centre
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in saturation of oxygen in the blood after a 6-minute walk test | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | During study session 2: immediately before beginning (pre-) and immediately after finishing (post-) each of four 6-minute walk tests | Measured with the modified 10-point Borg scale |
| Patient preference ratings | During study session 2: immediately after finishing (post-) each of four 6-minute walk tests | 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% | During study session 2: immediately after finishing (post-) each of four 6-minute walk tests | — |
Countries
Canada
Outcome results
None listed