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

Primary Purpose

Chronic Obstructive Lung Disease, Pulmonary Fibrosis

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Eclipse 3 portable oxygen concentrator
EverGo portable oxygen concentrator
iGo portable oxygen concentrator
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Lung Disease focused on measuring portable oxygen concentrator, 6-minute walk test, chronic obstructive lung disease, pulmonary fibrosis, long term oxygen therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Ottawa Hospital Rehabilitation Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Eclipse 3 portable oxygen concentrator

iGo portable oxygen concentrator

EverGo portable oxygen concentrator

Control portable oxygen concentrator

Arm Description

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.

Use of the iGo portable oxygen concentrator set at maximum pulse-dose setting 10-minutes prior to, and during a 6-minute walk test.

Use of the iGo portable oxygen concentrator set at maximum pulse-dose setting 10-minutes prior to, and during a 6-minute walk test.

6-minute walk test completed using each patient's own oxygen delivery system set at their usual oxygen prescription for exercise

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Total distance walked
Change in Dyspnea ratings after a 6-minute walk test
Measured with the modified 10-point Borg scale
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.
Walk time spent with oxygen saturation greater than or equal to 90%

Full Information

First Posted
July 16, 2012
Last Updated
July 27, 2012
Sponsor
Ottawa Hospital Research Institute
Collaborators
Institute for Rehabilitation Research and Development, The Ottawa Hospital Rehabilitation Centre
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1. Study Identification

Unique Protocol Identification Number
NCT01653730
Brief Title
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

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Institute for Rehabilitation Research and Development, The Ottawa Hospital Rehabilitation Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Lung Disease, Pulmonary Fibrosis
Keywords
portable oxygen concentrator, 6-minute walk test, chronic obstructive lung disease, pulmonary fibrosis, long term oxygen therapy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eclipse 3 portable oxygen concentrator
Arm Type
Experimental
Arm Description
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.
Arm Title
iGo portable oxygen concentrator
Arm Type
Experimental
Arm Description
Use of the iGo portable oxygen concentrator set at maximum pulse-dose setting 10-minutes prior to, and during a 6-minute walk test.
Arm Title
EverGo portable oxygen concentrator
Arm Type
Experimental
Arm Description
Use of the iGo portable oxygen concentrator set at maximum pulse-dose setting 10-minutes prior to, and during a 6-minute walk test.
Arm Title
Control portable oxygen concentrator
Arm Type
No Intervention
Arm Description
6-minute walk test completed using each patient's own oxygen delivery system set at their usual oxygen prescription for exercise
Intervention Type
Device
Intervention Name(s)
Eclipse 3 portable oxygen concentrator
Other Intervention Name(s)
Eclipse 3 (SeQual Technologies, San Diego, CA, USA)
Intervention Type
Device
Intervention Name(s)
EverGo portable oxygen concentrator
Other Intervention Name(s)
EverGo (Respironics Inc., Murrysville, PA, USA)
Intervention Type
Device
Intervention Name(s)
iGo portable oxygen concentrator
Other Intervention Name(s)
iGo (DeVillbiss Healthcare, Summerset, PA, USA)
Primary Outcome Measure Information:
Title
Change in saturation of oxygen in the blood after a 6-minute walk test
Description
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.
Time Frame
During study session 2: immediately before beginning (pre-) and immediately after finishing (post-) each of four 6-minute walk tests
Secondary Outcome Measure Information:
Title
Total distance walked
Time Frame
During study session 2: immediately after finishing (post-) each of four 6-minute walk tests
Title
Change in Dyspnea ratings after a 6-minute walk test
Description
Measured with the modified 10-point Borg scale
Time Frame
During study session 2: immediately before beginning (pre-) and immediately after finishing (post-) each of four 6-minute walk tests
Title
Patient preference ratings
Description
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.
Time Frame
During study session 2: immediately after finishing (post-) each of four 6-minute walk tests
Title
Walk time spent with oxygen saturation greater than or equal to 90%
Time Frame
During study session 2: immediately after finishing (post-) each of four 6-minute walk tests

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyne Lavallée, BSc(PT)
Organizational Affiliation
The Ottawa Hospital Rehabilitation Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carole Leblanc, RRT
Organizational Affiliation
The Ottawa Hospital Rehabilitation Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Doug McKim, MD
Organizational Affiliation
The Ottawa Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital Rehabilitation Centre
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8M2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
23550171
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.
Results Reference
derived

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

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