Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2016-09-30

Brief Summary

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Randomised cross-over study of portable oxygen concentrators compared to oxygen cylinders to improve quality of life and other outcomes for patients with chronic obstructive pulmonary disease.

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Detailed Description

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Many patients with Chronic Obstructive Pulmonary Disease (COPD) have limited activities of daily living (shopping, visiting friends, going for a walk) due to exertional dyspnoea. State Government funding provides up to 4 oxygen cylinders to be delivered to patients requiring portable oxygen per month. However, the more active and motivated COPD patients often find these gratis supplies run out well before the month is up. Recent technology has developed battery powered portable oxygen concentrators. The latest models weigh less than a typical oxygen cylinder and have the advantage that the battery plug can be plugged into a car cigarette lighter outlet, or into the power point of any house. This means that the COPD patient has the potential to be far more mobile for far longer periods of time and visit friends almost infinitely by recharging the battery pack during the course of their travels. The latest battery powered oxygen device weighs 2kgs which is about half that of an oxygen cylinder. However, there is an upfront expense to these devices and inevitably a sound business case with cost considerations (amortization of the initial purchase price, recharging the battery costing the patient's electricity etc) needs consideration. Also, before assuming these devices are superior (or at least as good as) oxygen cylinders, because they have a pulsed delivery of oxygen technology i.e. the oxygen is delivered in bursts with each inspiration that is detected, unlike oxygen cylinders which can run continuously, one cannot assume without rigorous evaluation that mobility and quality of life necessarily is good or superior with the new devices. Hence, quality of life evaluation with emphasis on enjoyed activities by each COPD patient are essential as well as costing issues for the funding stakeholder (i.e. hospital site specific funds). Should a sound business case be made (i.e. improved quality of life with less costs over a longer period of time), then a sound justification can be made to funding bodies that COPD patients are better off and the funding body is shouldering less cost by wider usage of these devices following evaluation of this project. The design will be a randomised crossover such that COPD patients will spend one month on oxygen or battery powered concentrator devices and then switch over to the other oxygen delivery. Chronic Respiratory Questionnaire (Quality of Life) will be administered at the end of each month.

Conditions

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COPD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Portable oxygen concentrators vs oxygen cylinders

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Portable Oxygen Cylinder

Group Type PLACEBO_COMPARATOR

Portable Oxygen

Intervention Type DEVICE

Portable Oxygen Concentrator

Group Type ACTIVE_COMPARATOR

Portable Oxygen

Intervention Type DEVICE

Interventions

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Portable Oxygen

Intervention Type DEVICE

Other Intervention Names

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Respironics Airsep (rental) AssetNumber 38269

Eligibility Criteria

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Inclusion Criteria

* Outpatients diagnosed with stable COPD
* currently prescribed and using portable oxygen cylinders with a "pulsed" oxygen delivery for exertion.

Exclusion Criteria

* Co-morbidities such as: other major respiratory conditions, cardiac or other substantial co-morbidities which significantly limit mobility independent of COPD
* Baseline step test which demonstrates a reduced effect on the battery device compared to oxygen cylinders.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No