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Completed

NCT Number: NCT03411876

Effects of Oxymizer Pendant Cannula Versus Conventional Nasal Cannula During Endurance Shuttle Walk Tests 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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Schön Klinik Berchtesgadener Land

Schönau am Königssee, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxymizer® pendant nasal cannula

Device

Supplemental oxygen is provided by an Oxymizer pendant nasal cannula.

conventional nasal cannula

Device

Supplemental oxygen is provided by a conventional nasal cannula.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Klaus Kenn

Other

Collaborators

  • Schön Klinik Berchtesgadener Land

Registry information

Official study 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

Acronym: IPF/Oxymizer2

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 26, 2018
Registry last updated
Apr 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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