Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2012 by The Queen Elizabeth Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Kristin Carson, The Queen Elizabeth Hospital
ClinicalTrials.gov Identifier:
NCT01673685
First received: August 15, 2012
Last updated: August 23, 2012
Last verified: August 2012
  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

Resource links provided by NLM:


Further study details as provided by The Queen Elizabeth Hospital:

Primary Outcome Measures:
  • Quality of life as measured through Chronic Respiratory Questionniar and PsyQol and [ Time Frame: One Month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
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

Contacts
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

Locations
Australia, South Australia
The Queen Elizabeth Hospital Recruiting
Woodville Road, Woodville, South Australia, Australia, 5022
Principal Investigator: Brian J Smith, MBBS, FRACP,PhD         
Sponsors and Collaborators
The Queen Elizabeth Hospital
Investigators
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 September 18, 2014