Effects of Oxymizer Pendant Cannula Versus Conventional Nasal Cannula During Endurance Shuttle Walk Tests in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis (IPF/Oxymizer2)

April 15, 2020 updated by: Klaus Kenn

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Schönau Am Königssee, Germany
        • Schön Klinik Berchtesgadener Land

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: First ESWT with Oxymizer, second ESWT with CNC
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
Supplemental oxygen is provided by an Oxymizer pendant nasal cannula.
Device: conventional nasal cannula
Supplemental oxygen is provided by a conventional nasal cannula.
Experimental: First ESWT with CNC, second ESWT with Oxymizer
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
Supplemental oxygen is provided by an Oxymizer pendant nasal cannula.
Device: conventional nasal cannula
Supplemental oxygen is provided by a conventional nasal cannula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endurance shuttle walk test distance
Time Frame: at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
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
Time Frame: at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
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
Time Frame: at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
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
Time Frame: at baseline, at isotime of endurance shuttle walk test and at the end (maximal 20 min) of endurance shuttle walk test
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
Time Frame: at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
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 Frame: From beginning of endurance shuttle walk test until the oxygen saturation reaches defined thresholds, or ESWT reaches maximum time frame of 20 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klaus Kenn

Collaborators

Schön Klinik Berchtesgadener Land

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2018

Primary Completion (Actual)

January 15, 2019

Study Completion (Actual)

January 15, 2019

Study Registration Dates

First Submitted

January 18, 2018

First Submitted That Met QC Criteria

January 25, 2018

First Posted (Actual)

January 26, 2018

Study Record Updates

Last Update Posted (Actual)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 15, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IPF Oxymizer study II

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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