Effects of Oxymizer Pendant Cannula Versus Conventional Nasal Cannula During Endurance Shuttle Walk Tests in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis

Study Overview
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Brief Summary
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Aim of this study is to investigate the effects of an Oxymizer pendant nasal cannula in hypoxemic patients with idiopathic pulmonary fibrosis during walking.

Detailed Description
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Patients will be recruited during an inpatient pulmonary rehabilitation program. They will perform three shuttle walk tests on three consecutive days (see below). While performing those tests, the patient's prescribed oxygen flow rate is applicated either through the conventional nasal cannula (CNC) or the Oxymizer.On the first day, patients perform an incremental shuttle walk test to determine maximum walking speed using a conventional nasal cannula. On two consecutive days, patients will perform two endurance shuttle walk tests at 85% of the maximum incremental shuttle walk test speed. Supplemental oxygen will be provided via nasal cannula at the prescribed oxygen flow rate. Patients will be randomly assigned to perform one test with the Oxymizer and the other one with a conventional nasal cannula.

Official Title
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Effects of an Oxymizer Pendant Cannula Versus a Conventional Nasal Cannula During Endurance Shuttle Walk Test (ESWT) in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis

Conditions
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Idiopathic Pulmonary Fibrosis, Hypoxemia

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: firmed diagnosis of idiopathic pulmonary fibrosis indication for supplemental oxygen therapy during exercise referred to an inpatient rehabilitation program at the Schön Klinik Berchtesgadener Land Exclusion Criteria: cardiovascular diseases that influence the patient's physical performance orthopedic comorbidities that prevent the patient from performing an incremental or endurance shuttle walk test carbon dioxide pressure above 45 mmHg at rest and ambient air
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: First ESWT with Oxymizer, second ESWT with CNC<br>Patients in this study arm first perform the first endurance shuttle walk test (ESWT) with the Oxymizer and the second ESWT with a conventional nasal cannula (CNC). | Device: Oxymizer® pendant nasal cannula<br>* Supplemental oxygen is provided by an Oxymizer pendant nasal cannula.<br>Device: conventional nasal cannula<br>* Supplemental oxygen is provided by a conventional nasal cannula.<br>|
| Experimental: First ESWT with CNC, second ESWT with Oxymizer<br>Patients in this study arm first perform the first endurance shuttle walk test (ESWT) with the CNC and the second ESWT with the Oxymizer. | Device: Oxymizer® pendant nasal cannula<br>* Supplemental oxygen is provided by an Oxymizer pendant nasal cannula.<br>Device: conventional nasal cannula<br>* Supplemental oxygen is provided by a conventional nasal cannula.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endurance shuttle walk test distance | Distance patients walk during an endurance shuttle walk test | at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygen saturation | measured by Sentec Digital Monitoring System | at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test | 
| heart rate | measured by Sentec Digital Monitoring System | at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test | 
| breathing frequency | measured by NoxT3 device | at baseline, at isotime of endurance shuttle walk test and at the end (maximal 20 min) of endurance shuttle walk test | 
| carbon dioxide pressure | transcutaneously carbon dioxide pressure measured by Sentec Digital Monitoring System | at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test | 
| time to desaturation | time (seconds) is measured until oxygen saturation drops below 90% or 85 % respectively | From beginning of endurance shuttle walk test until the oxygen saturation reaches defined thresholds, or ESWT reaches maximum time frame of 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IPF, Oxymizer, oxygen conserving device, pulmonary disease