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

NCT01653730 | Completed

• 1 other identifier: POC-325
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Lung Disease; Pulmonary Fibrosis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Total distance walked

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

• Change in Dyspnea ratings after a 6-minute walk test

  During study session 2: immediately before beginning (pre-) and immediately after finishing (post-) each of four 6-minute walk tests

• Patient preference ratings

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

• 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

Study Arms (4)

Eclipse 3 portable oxygen concentrator

EXPERIMENTAL

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

iGo portable oxygen concentrator

EXPERIMENTAL

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

EverGo portable oxygen concentrator

EXPERIMENTAL

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

Control portable oxygen concentrator

NO INTERVENTION

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

Interventions

Eclipse 3 portable oxygen concentrator DEVICE

Also known as: Eclipse 3 (SeQual Technologies, San Diego, CA, USA)

Eclipse 3 portable oxygen concentrator

EverGo portable oxygen concentrator DEVICE

Also known as: EverGo (Respironics Inc., Murrysville, PA, USA)

EverGo portable oxygen concentrator

iGo portable oxygen concentrator DEVICE

Also known as: iGo (DeVillbiss Healthcare, Summerset, PA, USA)

iGo portable oxygen concentrator

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The Ottawa Hospital Rehabilitation Centre

Ottawa, Ontario, K1H 8M2, Canada

Location

Related Publications (1)

• 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.

  PMID: 23550171 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 31, 2012
• Study Start: February 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: August 1, 2010
• Last Updated: July 31, 2012

Record last verified: 2012-07

Locations

CA (1)