Effects of an Oxymizer on Endurance Time in Patients With Chronic Lung Diseases

Study Overview
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Brief Summary
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The Oxymizer pendant® is a special oxygen cannula that can be used to supply high flow long term oxygen therapy. It is compatible with a wide variety of oxygen sources. In a reservoir, the Oxymizer® stores pure oxygen so that the concentration of inhaled oxygen is increased. The aim of this study is to investigate the potential benefit of the Oxymizer® with regard to the blood oxygenation during exercise testing. Given that the endurance time is very sensitive for little changes in exercise capacity, this test will be used to show the difference between the Oxymizer® and a conventional nasal cannula regarding exercise duration at 70% of peak Watt and oxygenation. The tests will be accompanied by blood gas analysis, partial pressure of carbon dioxide and heart rate.

Official Title
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Effects of an Oxymizer Versus Conventional Nasal Cannula on Endurance Time in Patients With Chronic Obstructive Pulmonary Disease IV (COPD) or Interstitial Lung Disease (ILD)

Conditions
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COPD, Interstitial Lung Disease

Intervention / Treatment
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* Device: Oxymizer
* Device: conventional nasal cannula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: COPD IV interstitial lung disease long-term oxygen therapy with oxygen flow rate >= 2 L/min Exclusion Criteria: acute cardial decompensation usual kontraindication for exposure test (higher-grad Hypertension (arterial and pulmonal), cardiac valve vitien, instabile angina pectoris, cardiac arrhythmia)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Oxymizer<br>Using first the Oxymizer and 24 h later the conventional nasal cannula. | Device: Oxymizer<br>* Using first the Oxymizer and 24 h later the conventional nasal cannula.<br>|
| Active Comparator: nasal cannula<br>Using first the conventional nasal cannula and 24 h later the Oxymizer | Device: conventional nasal cannula<br>* Using first the conventional nasal cannula and 24h later the Oxymizer<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between Endurance time with Oxymizer and conventional nasal cannula |  | From starting until stopping cycling, up to 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in oxygen saturation with Oxymizer and with conventional nasal cannula |  | stopping cycling, up to 60 minutes | 
| Difference in PaCO2 with Oxymizer and with conventional nasal cannula | measured by Sentec device | Stopping cycling, up to 60 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ILD, Oxymizer, endurance time, exercise test, nasal cannula, COPD, oxygenation