Ambulatory Oxygen for ILD
Effective Delivery of Ambulatory Oxygen in Interstitial Lung Disease - a Crossover Trial.
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Aug 2013
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 16, 2013
CompletedFirst Posted
Study publicly available on registry
July 24, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedJune 25, 2014
June 1, 2014
6 months
July 16, 2013
June 23, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Nadir SpO2
Lowest SpO2 recorded during the 6-min walk test on each device
During 6-min walk test with each oxygen delivery device
Secondary Outcomes (5)
6-min walk distance
End 6-min walk test with each oxygen delivery device
Borg dyspnoea score
End 6-min walk test with each oxygen delivery device
Borg fatigue score
End 6-min walk test with each oxygen delivery device
Partial pressure of oxygen in arterial blood (PaO2) at rest
Prior to 6-min walk test with each oxygen delivery device
Proportion of participants who desaturate to less than 80%
During 6-min walk test on each oxygen delivery device
Study Arms (2)
Portable Oxygen Concentrator first
EXPERIMENTALPortable oxygen cylinder first
ACTIVE COMPARATORInterventions
Respironics EverGo portable oxygen concentrator on setting 6
Portable oxygen cylinder at flow rate 5 Litres/min
Eligibility Criteria
You may qualify if:
- a confident diagnosis of ILD made according to established criteria and
- desaturate to less than 90% during a 6-minute walk test
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Anne Hollandlead
- The Alfredcollaborator
Study Sites (1)
Alfred Hospital
Melbourne, Victoria, 3004, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Chair, Physiotherapy
Study Record Dates
First Submitted
July 16, 2013
First Posted
July 24, 2013
Study Start
August 1, 2013
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
June 25, 2014
Record last verified: 2014-06