Clinical trial NCT01673685: Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators
Official title: Randomised Crossover Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: COPD
Oxygen cylinder
Portable oxygen cylinder
Battery powered delivery device
mobility
dyspnoea
Quality of Life
Cost effectiveness
Lead sponsor: The Queen Elizabeth Hospital
Sponsor class: OTHER
First posted: 2012-08-28
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Portable oxygen concentrators vs oxygen cylinders
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quality of life as measured through Chronic Respiratory Questionnaire
timeFrame: One month
Secondary outcomes:
measure: Patient Preference
timeFrame: One month
measure: Cost effectiveness of portable oxygen concentrator compared to cylinder
timeFrame: one month
measure: Quality of life as measured through AQoL-8D
timeFrame: One month
Other outcomes:
Locations:
city: Woodville Road, Woodville
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
Study officials:
affiliation: The Queen Elizabeth Hospital
name: Brian J Smith, MBBS, FRACP, PhD
role: PRINCIPAL_INVESTIGATOR
References: