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

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

Interventions

DEVICE

Eclipse 3 portable oxygen concentrator

DEVICE

EverGo portable oxygen concentrator

DEVICE

iGo portable oxygen concentrator

Sponsors & Collaborators

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

  collaborator UNKNOWN

• Ottawa Hospital Research Institute

  lead OTHER

Principal Investigators

• Lyne Lavallée, BSc(PT) · The Ottawa Hospital Rehabilitation Centre

• Carole Leblanc, RRT · The Ottawa Hospital Rehabilitation Centre

• Doug McKim, MD · The Ottawa Hospital

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-02-28

Primary Completion

2010-08-31

Completion

2010-08-31

Countries

• Canada

Study Locations