Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators
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ClinicalTrials.gov Identifier: NCT01673685 |
Recruitment Status
:
Completed
First Posted
: August 28, 2012
Last Update Posted
: April 10, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
COPD | Device: Portable Oxygen | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Portable oxygen concentrators vs oxygen cylinders |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomised Crossover Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators |
Study Start Date : | October 2010 |
Actual Primary Completion Date : | July 2016 |
Actual Study Completion Date : | September 2016 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Portable Oxygen Cylinder
Portable Oxygen Cylinder
|
Device: Portable Oxygen
Other Name: Respironics Airsep (rental) AssetNumber 38269
|
Active Comparator: Portable Oxygen Concentrator
Portable Oxygen Concentrator
|
Device: Portable Oxygen
Other Name: Respironics Airsep (rental) AssetNumber 38269
|
- Quality of life as measured through Chronic Respiratory Questionnaire [ Time Frame: One month ]only two subdomains of the Chronic Respiratory Questionnaire (CRQ) were used: the Shortness of Breath (SoB) domain and the Mastery domain
- Patient Preference [ Time Frame: One month ]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.
- Cost effectiveness of portable oxygen concentrator compared to cylinder [ Time Frame: one month ]Economic assessment based on treatment cost, readmission data and hospital utilisation
- Quality of life as measured through AQoL-8D [ Time Frame: One month ]Assessment of Quality of Life (AQoL)-8D Multi-Attribute Utility Instrument

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673685
Australia, South Australia | |
The Queen Elizabeth Hospital | |
Woodville Road, Woodville, South Australia, Australia, 5022 |
Principal Investigator: | Brian J Smith, MBBS, FRACP, PhD | The Queen Elizabeth Hospital |
Responsible Party: | Kristin Carson, Research Scientist, The Queen Elizabeth Hospital |
ClinicalTrials.gov Identifier: | NCT01673685 History of Changes |
Other Study ID Numbers: |
2010090 |
First Posted: | August 28, 2012 Key Record Dates |
Last Update Posted: | April 10, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | IPD will be available upon request. |
Keywords provided by Kristin Carson, The Queen Elizabeth Hospital:
COPD Oxygen cylinder Portable oxygen cylinder Battery powered delivery device |
mobility dyspnoea Quality of Life Cost effectiveness |