Ambulatory Oxygen for ILD
Primary Purpose
Interstitial Lung Disease
Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Portable oxygen concentrator
Portable oxygen cylinder
Sponsored by
About this trial
This is an interventional treatment trial for Interstitial Lung Disease focused on measuring Interstitial lung disease, Oxygen therapy, Walk
Eligibility Criteria
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
Sites / Locations
- Alfred Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Portable Oxygen Concentrator first
Portable oxygen cylinder first
Arm Description
Outcomes
Primary Outcome Measures
Nadir SpO2
Lowest SpO2 recorded during the 6-min walk test on each device
Secondary Outcome Measures
6-min walk distance
The distance walked in 6 minutes with each oxygen delivery device will be compared
Borg dyspnoea score
Borg dyspnoea score at the end of the 6-min walk test will be compared between devices
Borg fatigue score
Borg 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 rest
PaO2 at rest breathing oxygen from each of the two devices will be compared
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
Full Information
NCT ID
NCT01906931
First Posted
July 16, 2013
Last Updated
June 23, 2014
Sponsor
Anne Holland
Collaborators
The Alfred
1. Study Identification
Unique Protocol Identification Number
NCT01906931
Brief Title
Ambulatory Oxygen for ILD
Official Title
Effective Delivery of Ambulatory Oxygen in Interstitial Lung Disease - a Crossover Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anne Holland
Collaborators
The Alfred
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Interstitial Lung Disease
Keywords
Interstitial lung disease, Oxygen therapy, Walk
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Portable Oxygen Concentrator first
Arm Type
Experimental
Arm Title
Portable oxygen cylinder first
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Portable oxygen concentrator
Other Intervention Name(s)
Respironics EverGo portable oxygen concentrator
Intervention Description
Respironics EverGo portable oxygen concentrator on setting 6
Intervention Type
Device
Intervention Name(s)
Portable oxygen cylinder
Intervention Description
Portable oxygen cylinder at flow rate 5 Litres/min
Primary Outcome Measure Information:
Title
Nadir SpO2
Description
Lowest SpO2 recorded during the 6-min walk test on each device
Time Frame
During 6-min walk test with each oxygen delivery device
Secondary Outcome Measure Information:
Title
6-min walk distance
Description
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
Title
Borg dyspnoea score
Description
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
Title
Borg fatigue score
Description
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
Title
Partial pressure of oxygen in arterial blood (PaO2) at rest
Description
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
Title
Proportion of participants who desaturate to less than 80%
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
12. IPD Sharing Statement
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Ambulatory Oxygen for ILD
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