Back to resultsEffects of Oxymizer Pendant Cannula Versus Conventional Nasal Cannula During Endurance Shuttle Walk Tests in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis (IPF/Oxymizer2)
Primary Purpose
Idiopathic Pulmonary Fibrosis, Hypoxemia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Oxymizer® pendant nasal cannula
conventional nasal cannula
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring IPF, Oxymizer, oxygen conserving device, pulmonary disease
Eligibility Criteria
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
Sites / Locations
- Schön Klinik Berchtesgadener Land
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
First ESWT with Oxymizer, second ESWT with CNC
First ESWT with CNC, second ESWT with Oxymizer
Arm Description
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).
Patients in this study arm first perform the first endurance shuttle walk test (ESWT) with the CNC and the second ESWT with the Oxymizer.
Outcomes
Primary Outcome Measures
Endurance shuttle walk test distance
Distance patients walk during an endurance shuttle walk test
Secondary Outcome Measures
oxygen saturation
measured by Sentec Digital Monitoring System
heart rate
measured by Sentec Digital Monitoring System
breathing frequency
measured by NoxT3 device
carbon dioxide pressure
transcutaneously carbon dioxide pressure measured by Sentec Digital Monitoring System
time to desaturation
time (seconds) is measured until oxygen saturation drops below 90% or 85 % respectively
Full Information
NCT ID
NCT03411876
First Posted
January 18, 2018
Last Updated
April 15, 2020
Sponsor
Klaus Kenn
Collaborators
Schön Klinik Berchtesgadener Land
1. Study Identification
Unique Protocol Identification Number
NCT03411876
Brief Title
Effects of Oxymizer Pendant Cannula Versus Conventional Nasal Cannula During Endurance Shuttle Walk Tests in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis
Acronym
IPF/Oxymizer2
Official Title
Effects of an Oxymizer Pendant Cannula Versus a Conventional Nasal Cannula During Endurance Shuttle Walk Test (ESWT) in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 18, 2018 (Actual)
Primary Completion Date
January 15, 2019 (Actual)
Study Completion Date
January 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Klaus Kenn
Collaborators
Schön Klinik Berchtesgadener Land
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis, Hypoxemia
Keywords
IPF, Oxymizer, oxygen conserving device, pulmonary disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
First ESWT with Oxymizer, second ESWT with CNC
Arm Type
Experimental
Arm Description
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).
Arm Title
First ESWT with CNC, second ESWT with Oxymizer
Arm Type
Experimental
Arm Description
Patients in this study arm first perform the first endurance shuttle walk test (ESWT) with the CNC and the second ESWT with the Oxymizer.
Intervention Type
Device
Intervention Name(s)
Oxymizer® pendant nasal cannula
Intervention Description
Supplemental oxygen is provided by an Oxymizer pendant nasal cannula.
Intervention Type
Device
Intervention Name(s)
conventional nasal cannula
Intervention Description
Supplemental oxygen is provided by a conventional nasal cannula.
Primary Outcome Measure Information:
Title
Endurance shuttle walk test distance
Description
Distance patients walk during an endurance shuttle walk test
Time Frame
at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
Secondary Outcome Measure Information:
Title
oxygen saturation
Description
measured by Sentec Digital Monitoring System
Time Frame
at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
Title
heart rate
Description
measured by Sentec Digital Monitoring System
Time Frame
at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
Title
breathing frequency
Description
measured by NoxT3 device
Time Frame
at baseline, at isotime of endurance shuttle walk test and at the end (maximal 20 min) of endurance shuttle walk test
Title
carbon dioxide pressure
Description
transcutaneously carbon dioxide pressure measured by Sentec Digital Monitoring System
Time Frame
at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
Title
time to desaturation
Description
time (seconds) is measured until oxygen saturation drops below 90% or 85 % respectively
Time Frame
From beginning of endurance shuttle walk test until the oxygen saturation reaches defined thresholds, or ESWT reaches maximum time frame of 20 minutes
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Schön Klinik Berchtesgadener Land
City
Schönau Am Königssee
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Oxymizer Pendant Cannula Versus Conventional Nasal Cannula During Endurance Shuttle Walk Tests in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis
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