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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01653730
• Other study ID #: POC-325
• Status: Completed
• Phase: N/A
• First received: July 16, 2012
• Last updated: July 27, 2012
• Start date: February 2010
• Est. completion date: August 2010

Study information

• Verified date: July 2012
• Source: Ottawa Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Obstructive Lung Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Fibrosis

Intervention

Device:
• Eclipse 3 portable oxygen concentrator

• EverGo portable oxygen concentrator

• iGo portable oxygen concentrator

Locations

Country	Name	City	State
Canada	The Ottawa Hospital Rehabilitation Centre	Ottawa	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Ottawa Hospital Research Institute	Institute for Rehabilitation Research and Development, The Ottawa Hospital Rehabilitation Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Total distance walked		During study session 2: immediately after finishing (post-) each of four 6-minute walk tests	No
Secondary	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	No
Secondary	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	No
Secondary	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	No