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Ambulatory Oxygen for ILD

Effective Delivery of Ambulatory Oxygen in Interstitial Lung Disease - a Crossover Trial.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01906931
Enrollment
10
Registered
2013-07-24
Start date
2013-08-31
Completion date
2014-02-28
Last updated
2014-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease

Keywords

Interstitial lung disease, Oxygen therapy, Walk

Brief summary

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.

Detailed description

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.

Interventions

Respironics EverGo portable oxygen concentrator on setting 6

Portable oxygen cylinder at flow rate 5 Litres/min

Sponsors

The Alfred
CollaboratorOTHER
Anne Holland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* a confident diagnosis of ILD made according to established criteria and * desaturate to less than 90% during a 6-minute walk test

Exclusion criteria

* primary diagnosis of a respiratory condition other than ILD (eg COPD) * currently using continuous oxygen therapy * oxyhaemoglobin saturation (SpO2) is less than 90% on room air * unable to perform a 6-minute walk test or comorbidities that limit walking

Design outcomes

Primary

MeasureTime frameDescription
Nadir SpO2During 6-min walk test with each oxygen delivery deviceLowest SpO2 recorded during the 6-min walk test on each device

Secondary

MeasureTime frameDescription
6-min walk distanceEnd 6-min walk test with each oxygen delivery deviceThe distance walked in 6 minutes with each oxygen delivery device will be compared
Borg dyspnoea scoreEnd 6-min walk test with each oxygen delivery deviceBorg dyspnoea score at the end of the 6-min walk test will be compared between devices
Borg fatigue scoreEnd 6-min walk test with each oxygen delivery deviceBorg fatigue score at the end of the 6-min walk test will be compared between devices
Partial pressure of oxygen in arterial blood (PaO2) at restPrior to 6-min walk test with each oxygen delivery devicePaO2 at rest breathing oxygen from each of the two devices will be compared
Proportion of participants who desaturate to less than 80%During 6-min walk test on each oxygen delivery deviceProportion of participants who desaturate to less than 80% with each oxygen delivery device will be compared

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026