Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators

Study Overview
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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.

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.

Official Title
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Randomised Crossover Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators

Conditions
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COPD

Intervention / Treatment
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* Device: Portable Oxygen


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Portable oxygen concentrators vs oxygen cylinders
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Portable Oxygen Cylinder<br>Portable Oxygen Cylinder | Device: Portable Oxygen<br> <br> * Other names: Respironics Airsep (rental) AssetNumber 38269;|
| Active Comparator: Portable Oxygen Concentrator<br>Portable Oxygen Concentrator | Device: Portable Oxygen<br> <br> * Other names: Respironics Airsep (rental) AssetNumber 38269;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life as measured through Chronic Respiratory Questionnaire | only two subdomains of the Chronic Respiratory Questionnaire (CRQ) were used: the Shortness of Breath (SoB) domain and the Mastery domain | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Preference | Five 7-point Likert Scales, ranging from 1 (none of the time) to 7 (all of the time) on portability (the equipment was portable enough for my needs), operation (I was able to set up and operate the equipment properly), noise (Noise from the equipment affected me), comprehension (I was able to understand the functions of the equipment, e.g. alarms) and duration (The oxygen lasted long enough for me to perform my normal activities). Furthermore, patients were asked to provide comments on use of the POCs and the Cylinders after they completed the respective stage of the trial. | One month | 
| Cost effectiveness of portable oxygen concentrator compared to cylinder | Economic assessment based on treatment cost, readmission data and hospital utilisation | one month | 
| Quality of life as measured through AQoL-8D | Assessment of Quality of Life (AQoL)-8D Multi-Attribute Utility Instrument | One month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Oxygen cylinder, Portable oxygen cylinder, Battery powered delivery device, mobility, dyspnoea, Quality of Life, Cost effectiveness