A Phase 2 interventional study of Portable oxygen concentrator and Portable oxygen cylinder in Interstitial Lung Disease, sponsored by Anne Holland. Completed at 1 site in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-25.
Sponsored by Anne Holland · Phase 2, Interventional, and Treatment
People with interstitial lung disease (ILD) are frequently prescribed ambulatory oxygen, to increase oxygen levels in the blood during daily activities. The best way of delivering this type of oxygen has not been established. The aim of this study is to compare two devices for delivering oxygen in people with interstitial lung disease - the traditional method using portable cylinders and a newer method using a portable concentrator. The investigators hypothesise that oxygen levels during exercise will be significantly higher when using a portable cylinder, but this difference will be small.
Exercise-induced hypoxaemia (EIA) is very common in individuals with ILD, due to progressive lung fibrosis which results in impaired gas exchange. It is common for people with EIA to be prescribed ambulatory oxygen, in order to normalize oxyhaemoglobin saturation, improve oxygen delivery to the tissues and relieve breathlessness during daily activities.
Ambulatory oxygen is traditionally delivered via a refillable portable oxygen cylinder containing compressed gaseous oxygen. More recently, portable oxygen concentrators (POCs) have emerged as a solution to the problem of finite cylinder life and to improve portability. Because a concentrator is constantly extracting oxygen from air, oxygen supply can continue as long as the battery is charged. This is typically around eight hours, but POCs can be recharged from an AC or DC power source. Portable oxygen concentrators usually weigh around 3.5kg, which is significantly lighter than oxygen cylinders, and are much easier to maneuver. However, there are some theoretical disadvantages to POCs. Like all concentrators, they do not deliver 100% oxygen. Concentrations typically range from 85-95%, depending on the flow rate. Differences in pulse timing and peak pulse flow between POCs may affect the fraction of inspired oxygen (FiO2) that is delivered. However, the clinical implications of these differences have not been documented.
The aim of this study is to compare the effects of ambulatory oxygen delivered during exercise using the EverGo POC to ambulatory oxygen delivered with a standard portable cylinder in individuals with ILD. We hypothesise that oxyhaemoglobin saturation during exercise will be significantly higher when using a portable cylinder, but this difference will not be clinically important.
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This study's planned enrollment of 10 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
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Exclusion Criteria:
Device: Portable oxygen concentrator · Device: Portable oxygen cylinder
Device: Portable oxygen concentrator · Device: Portable oxygen cylinder
Respironics EverGo portable oxygen concentrator on setting 6
Also known as: Respironics EverGo portable oxygen concentrator
Portable oxygen cylinder at flow rate 5 Litres/min
Nadir SpO2
Lowest SpO2 recorded during the 6-min walk test on each device
Time frame: During 6-min walk test with each oxygen delivery device
6-min walk distance
The distance walked in 6 minutes with each oxygen delivery device will be compared
Time frame: End 6-min walk test with each oxygen delivery device
Borg dyspnoea score
Borg dyspnoea score at the end of the 6-min walk test will be compared between devices
Time frame: End 6-min walk test with each oxygen delivery device
Borg fatigue score
Borg fatigue score at the end of the 6-min walk test will be compared between devices
Time frame: End 6-min walk test with each oxygen delivery device
Partial pressure of oxygen in arterial blood (PaO2) at rest
PaO2 at rest breathing oxygen from each of the two devices will be compared
Time frame: Prior to 6-min walk test with each oxygen delivery device
Proportion of participants who desaturate to less than 80%
Proportion of participants who desaturate to less than 80% with each oxygen delivery device will be compared
Time frame: During 6-min walk test on each oxygen delivery device
This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.
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