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OpenTrials
Completed

NCT Number: NCT01906931

Ambulatory Oxygen for ILD

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alfred Hospital

Melbourne, Victoria, 3004, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Portable oxygen concentrator

Device

Respironics EverGo portable oxygen concentrator on setting 6

Other names: Respironics EverGo portable oxygen concentrator

Portable oxygen cylinder

Device

Portable oxygen cylinder at flow rate 5 Litres/min

Primary outcomes

  1. Nadir SpO2

    Time frame: During 6-min walk test with each oxygen delivery device

    Lowest SpO2 recorded during the 6-min walk test on each device

Secondary outcomes

  1. 6-min walk distance

    Time frame: End 6-min walk test with each oxygen delivery device

    The distance walked in 6 minutes with each oxygen delivery device will be compared

  2. Borg dyspnoea score

    Time frame: End 6-min walk test with each oxygen delivery device

    Borg dyspnoea score at the end of the 6-min walk test will be compared between devices

  3. Borg fatigue score

    Time frame: End 6-min walk test with each oxygen delivery device

    Borg fatigue score at the end of the 6-min walk test will be compared between devices

  4. Partial pressure of oxygen in arterial blood (PaO2) at rest

    Time frame: Prior to 6-min walk test with each oxygen delivery device

    PaO2 at rest breathing oxygen from each of the two devices will be compared

  5. Proportion of participants who desaturate to less than 80%

    Time frame: During 6-min walk test on each oxygen delivery device

    Proportion of participants who desaturate to less than 80% with each oxygen delivery device will be compared

Sponsors and collaborators

Lead sponsor

Anne Holland

Other

Collaborators

  • The Alfred

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 24, 2013
Registry last updated
Jun 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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