Completed

Randomised Crossover Trial of Portable Oxygen Cylinders Versus Battery Powered Portable Oxygen Concentrators

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Portable Oxygen

+ Portable Oxygen

Device
Who is being recruted

Chronic Disease+9

+ Lung Diseases

+ Lung Diseases, Obstructive

From 18 to 85 Years
+4 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: October 2010
See protocol details

Summary

Principal SponsorThe Queen Elizabeth Hospital
Last updated: April 10, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: October 1, 2010

Actual date on which the first participant was enrolled.

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.

Principal SponsorThe Queen Elizabeth Hospital
Last updated: April 10, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

32 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseLung DiseasesLung Diseases, ObstructivePathologic ProcessesRespiration DisordersRespiratory Tract DiseasesSigns and SymptomsSigns and Symptoms, RespiratoryPathological Conditions, Signs and SymptomsDisease AttributesDyspneaPulmonary Disease, Chronic Obstructive

Criteria

2 inclusion criteria required to participate
Outpatients diagnosed with stable COPD

currently prescribed and using portable oxygen cylinders with a "pulsed" oxygen delivery for exertion

2 exclusion criteria prevent from participating
Baseline step test which demonstrates a reduced effect on the battery device compared to oxygen cylinders

Co-morbidities such as: other major respiratory conditions, cardiac or other substantial co-morbidities which significantly limit mobility independent of COPD

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Placebo
Portable Oxygen Cylinder

Group II

Active Comparator
Portable Oxygen Concentrator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

The Queen Elizabeth Hospital

Woodville Road, Woodville, AustraliaOpen The Queen Elizabeth Hospital in Google Maps
CompletedOne Study Center