Ambulatory Oxygen for ILD

This study has been completed.
Sponsor:
Collaborator:
The Alfred
Information provided by (Responsible Party):
Anne Holland, The Alfred
ClinicalTrials.gov Identifier:
NCT01906931
First received: July 16, 2013
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Interstitial Lung Disease
Device: Portable oxygen concentrator
Device: Portable oxygen cylinder
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effective Delivery of Ambulatory Oxygen in Interstitial Lung Disease - a Crossover Trial.

Resource links provided by NLM:


Further study details as provided by The Alfred:

Primary Outcome Measures:
  • Nadir SpO2 [ Time Frame: During 6-min walk test with each oxygen delivery device ] [ Designated as safety issue: No ]
    Lowest SpO2 recorded during the 6-min walk test on each device


Secondary Outcome Measures:
  • 6-min walk distance [ Time Frame: End 6-min walk test with each oxygen delivery device ] [ Designated as safety issue: No ]
    The distance walked in 6 minutes with each oxygen delivery device will be compared

  • Borg dyspnoea score [ Time Frame: End 6-min walk test with each oxygen delivery device ] [ Designated as safety issue: No ]
    Borg dyspnoea score at the end of the 6-min walk test will be compared between devices

  • Borg fatigue score [ Time Frame: End 6-min walk test with each oxygen delivery device ] [ Designated as safety issue: No ]
    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 [ Time Frame: Prior to 6-min walk test with each oxygen delivery device ] [ Designated as safety issue: No ]
    PaO2 at rest breathing oxygen from each of the two devices will be compared

  • Proportion of participants who desaturate to less than 80% [ Time Frame: During 6-min walk test on each oxygen delivery device ] [ Designated as safety issue: Yes ]
    Proportion of participants who desaturate to less than 80% with each oxygen delivery device will be compared


Estimated Enrollment: 10
Study Start Date: August 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Portable Oxygen Concentrator first Device: Portable oxygen concentrator
Respironics EverGo portable oxygen concentrator on setting 6
Other Name: 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 Name: Respironics EverGo portable oxygen concentrator
Device: Portable oxygen cylinder
Portable oxygen cylinder at flow rate 5 Litres/min

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01906931

Locations
Australia, Victoria
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Sponsors and Collaborators
Anne Holland
The Alfred
  More Information

No publications provided

Responsible Party: Anne Holland, Clinical Chair, Physiotherapy, The Alfred
ClinicalTrials.gov Identifier: NCT01906931     History of Changes
Other Study ID Numbers: 187_13
Study First Received: July 16, 2013
Last Updated: June 23, 2014
Health Authority: Australia: National Health and Medical Research Council

Keywords provided by The Alfred:
Interstitial lung disease
Oxygen therapy
Walk

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Interstitial
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014