Ambulatory Oxygen for ILD

Interstitial Lung Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01906931
• Other study ID #: 187_13
• Status: Completed
• Phase: Phase 2
• First received: July 16, 2013
• Last updated: June 23, 2014
• Start date: August 2013
• Est. completion date: February 2014

Study information

• Verified date: June 2014
• Source: The Alfred
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research Council
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial

Intervention

Device:
• Portable oxygen concentrator
Respironics EverGo portable oxygen concentrator on setting 6
• Portable oxygen cylinder
Portable oxygen cylinder at flow rate 5 Litres/min

Locations

Country	Name	City	State
Australia	Alfred Hospital	Melbourne	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Anne Holland	The Alfred

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nadir SpO2	Lowest SpO2 recorded during the 6-min walk test on each device	During 6-min walk test with each oxygen delivery device	No
Secondary	6-min walk distance	The distance walked in 6 minutes with each oxygen delivery device will be compared	End 6-min walk test with each oxygen delivery device	No
Secondary	Borg dyspnoea score	Borg dyspnoea score at the end of the 6-min walk test will be compared between devices	End 6-min walk test with each oxygen delivery device	No
Secondary	Borg fatigue score	Borg fatigue score at the end of the 6-min walk test will be compared between devices	End 6-min walk test with each oxygen delivery device	No
Secondary	Partial pressure of oxygen in arterial blood (PaO2) at rest	PaO2 at rest breathing oxygen from each of the two devices will be compared	Prior to 6-min walk test with each oxygen delivery device	No
Secondary	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	During 6-min walk test on each oxygen delivery device	Yes