Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators
Recruitment status was Recruiting
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Purpose
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 rigourous 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.
| Condition | Intervention | Phase |
|---|---|---|
|
COPD |
Device: Portable Oxygen |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomised Crossover Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators |
- Quality of life as measured through Chronic Respiratory Questionniar and PsyQol and [ Time Frame: One Month ] [ Designated as safety issue: No ]
- Dyspnoea as measured through the Borg Scale [ Time Frame: One month ] [ Designated as safety issue: No ]
- Patient Prefterence [ Time Frame: One Month ] [ Designated as safety issue: No ]
- Adverse Events through self report [ Time Frame: One month ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: One month ] [ Designated as safety issue: No ]
- Cost effectiveness [ Time Frame: one month ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2010 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Portable Oxygen Cylinder
Portable Oxygen concentrator
|
|
|
Active Comparator: Portable Oxygen Concentrator
Portable Oxygen Concentrator
|
Device: Portable Oxygen
Other Name: Respironics Airsep (rental) AssetNumber 38269
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01673685
| Contact: Brian A/Prof Smith, PHD | +61 8222 6000 ext 27966 | brian.smith@health.sa.gov.au | |
| Contact: Nadina Labiszewski, BSoc Sc | +61 8222 6000 ext 27834 | nadina.labiszewski@health.sa.gov.au |
| Australia, South Australia | |
| The Queen Elizabeth Hospital | Recruiting |
| Woodville Road, Woodville, South Australia, Australia, 5022 | |
| Principal Investigator: Brian J Smith, MBBS, FRACP,PhD | |
| Principal Investigator: | Brian J Smith, MBBS, FRACP, PhD | The Queen Elizabeth Hospital |
More Information
No publications provided
| Responsible Party: | Kristin Carson, Research Scientist, The Queen Elizabeth Hospital |
| ClinicalTrials.gov Identifier: | NCT01673685 History of Changes |
| Other Study ID Numbers: | 2010090 |
| Study First Received: | August 15, 2012 |
| Last Updated: | August 23, 2012 |
| Health Authority: | Australia: Human Research Ethics Committee |
Keywords provided by The Queen Elizabeth Hospital:
|
COPD Oxygen cylinder Portable oxygen cylinder Battery powered delivery device |
mobility dyspnoea Quality of Life Cost effectiveness |
ClinicalTrials.gov processed this record on March 03, 2015