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Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kristin Carson, The Queen Elizabeth Hospital
ClinicalTrials.gov Identifier:
NCT01673685
First received: August 15, 2012
Last updated: April 6, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
COPD Device: Portable Oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Portable oxygen concentrators vs oxygen cylinders
Masking: No masking
Primary Purpose: Treatment
Official Title: Randomised Crossover Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators

Resource links provided by NLM:


Further study details as provided by Kristin Carson, The Queen Elizabeth Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 32
Study Start Date: October 2010
Study Completion Date: September 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673685

Locations
Australia, South Australia
The Queen Elizabeth Hospital
Woodville Road, Woodville, South Australia, Australia, 5022
Sponsors and Collaborators
The Queen Elizabeth Hospital
Investigators
Principal Investigator: Brian J Smith, MBBS, FRACP, PhD The Queen Elizabeth Hospital
  More Information

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: April 6, 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

ClinicalTrials.gov processed this record on July 27, 2017