Pulmonary Fibrosis Clinical Trial
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.
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.
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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