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NCT Number: NCT01653730

Comparative Study of 3 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.

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Key information

Conditions

Chronic Obstructive Lung Disease Chronic Disease Disease Attributes Fibrosis Lung Diseases Lung Diseases, Interstitial Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Ottawa Hospital Rehabilitation Centre

Ottawa, Ontario, K1H 8M2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eclipse 3 portable oxygen concentrator

Device

Other names: Eclipse 3 (SeQual Technologies, San Diego, CA, USA)

EverGo portable oxygen concentrator

Device

Other names: EverGo (Respironics Inc., Murrysville, PA, USA)

iGo portable oxygen concentrator

Device

Other names: iGo (DeVillbiss Healthcare, Summerset, PA, USA)

Primary outcomes

  1. 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

    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 outcomes

  1. Total distance walked

    Time frame: During study session 2: immediately after finishing (post-) each of four 6-minute walk tests

  2. 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

    Measured with the modified 10-point Borg scale

  3. Patient preference ratings

    Time frame: During study session 2: immediately after finishing (post-) each of four 6-minute walk tests

    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.

  4. 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

Sponsors and collaborators

Lead sponsor

Ottawa Hospital Research Institute

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 31, 2012
Registry last updated
Jul 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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