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

This study has been completed.
Sponsor:
Collaborator:
Institute for Rehabilitation Research and Development, The Ottawa Hospital Rehabilitation Centre
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01653730
First received: July 16, 2012
Last updated: July 27, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention
Chronic Obstructive Lung Disease
Pulmonary Fibrosis
Device: Eclipse 3 portable oxygen concentrator
Device: EverGo portable oxygen concentrator
Device: iGo portable oxygen concentrator

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

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Change in saturation of oxygen in the blood after a 6-minute walk test [ Time Frame: During study session 2: immediately before beginning (pre-) and immediately after finishing (post-) each of four 6-minute walk tests ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: During study session 2: immediately after finishing (post-) each of four 6-minute walk tests ] [ Designated as safety issue: No ]
  • Change in Dyspnea ratings after a 6-minute walk test [ Time Frame: During study session 2: immediately before beginning (pre-) and immediately after finishing (post-) each of four 6-minute walk tests ] [ Designated as safety issue: No ]
    Measured with the modified 10-point Borg scale

  • Patient preference ratings [ Time Frame: During study session 2: immediately after finishing (post-) each of four 6-minute walk tests ] [ Designated as safety issue: No ]
    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% [ Time Frame: During study session 2: immediately after finishing (post-) each of four 6-minute walk tests ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: February 2010
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Device: Eclipse 3 portable oxygen concentrator
Other Name: Eclipse 3 (SeQual Technologies, San Diego, CA, USA)
Experimental: 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.
Device: iGo portable oxygen concentrator
Other Name: iGo (DeVillbiss Healthcare, Summerset, PA, USA)
Experimental: 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.
Device: EverGo portable oxygen concentrator
Other Name: EverGo (Respironics Inc., Murrysville, PA, USA)
No Intervention: 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653730

Locations
Canada, Ontario
The Ottawa Hospital Rehabilitation Centre
Ottawa, Ontario, Canada, K1H 8M2
Sponsors and Collaborators
Ottawa Hospital Research Institute
Institute for Rehabilitation Research and Development, The Ottawa Hospital Rehabilitation Centre
Investigators
Principal Investigator: Lyne Lavallée, BSc(PT) The Ottawa Hospital Rehabilitation Centre
Principal Investigator: Carole Leblanc, RRT The Ottawa Hospital Rehabilitation Centre
Principal Investigator: Doug McKim, MD The Ottawa Hospital
  More Information

No publications provided by Ottawa Hospital Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01653730     History of Changes
Other Study ID Numbers: POC-325
Study First Received: July 16, 2012
Last Updated: July 27, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Ottawa Hospital Research Institute:
portable oxygen concentrator
6-minute walk test
chronic obstructive lung disease
pulmonary fibrosis
long term oxygen therapy

Additional relevant MeSH terms:
Fibrosis
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Pulmonary Fibrosis
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 22, 2014