Ambulatory Oxygen for ILD

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

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.

Study Overview

• Status: Completed
• Conditions: Interstitial Lung Disease
• Intervention / Treatment: Device: Portable oxygen concentrator; Device: Portable oxygen cylinder

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.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Alfred Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Portable Oxygen Concentrator first	Device: Portable oxygen concentrator; Respironics EverGo portable oxygen concentrator on setting 6; Other Names: Respironics EverGo portable oxygen concentrator; Device: Portable oxygen cylinder; Portable oxygen cylinder at flow rate 5 Litres/min
Active Comparator: Portable oxygen cylinder first	Device: Portable oxygen concentrator; Respironics EverGo portable oxygen concentrator on setting 6; Other Names: Respironics EverGo portable oxygen concentrator; Device: Portable oxygen cylinder; Portable oxygen cylinder at flow rate 5 Litres/min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Anne Holland
• Collaborators: The Alfred

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): February 1, 2014

Study Registration Dates

• First Submitted: July 16, 2013
• First Submitted That Met QC Criteria: July 22, 2013
• First Posted (Estimate): July 24, 2013

Study Record Updates

• Last Update Posted (Estimate): June 25, 2014
• Last Update Submitted That Met QC Criteria: June 23, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Oxygen therapy; Interstitial lung disease; Walk
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: 187_13