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

NCT ID: NCT01653730

Last Updated: 2012-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2010-08-31

Brief Summary

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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

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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.

Conditions

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Chronic Obstructive Lung Disease Pulmonary Fibrosis

Keywords

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portable oxygen concentrator 6-minute walk test chronic obstructive lung disease pulmonary fibrosis long term oxygen therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Eclipse 3 portable oxygen concentrator

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.

Group Type EXPERIMENTAL

Eclipse 3 portable oxygen concentrator

Intervention Type DEVICE

iGo portable oxygen concentrator

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

Group Type EXPERIMENTAL

iGo portable oxygen concentrator

Intervention Type DEVICE

EverGo portable oxygen concentrator

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

Group Type EXPERIMENTAL

EverGo portable oxygen concentrator

Intervention Type DEVICE

Control portable oxygen concentrator

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Eclipse 3 portable oxygen concentrator

Intervention Type DEVICE

EverGo portable oxygen concentrator

Intervention Type DEVICE

iGo portable oxygen concentrator

Intervention Type DEVICE

Other Intervention Names

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Eclipse 3 (SeQual Technologies, San Diego, CA, USA) EverGo (Respironics Inc., Murrysville, PA, USA) iGo (DeVillbiss Healthcare, Summerset, PA, USA)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute for Rehabilitation Research and Development, The Ottawa Hospital Rehabilitation Centre

UNKNOWN

Sponsor Role collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lyne Lavallée, BSc(PT)

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital Rehabilitation Centre

Carole Leblanc, RRT

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital Rehabilitation Centre

Doug McKim, MD

Role: PRINCIPAL_INVESTIGATOR

The Ottawa Hospital

Locations

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The Ottawa Hospital Rehabilitation Centre

Ottawa, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 23550171 (View on PubMed)

Other Identifiers

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POC-325

Identifier Type: -

Identifier Source: org_study_id