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

NCT ID: NCT03411876

Last Updated: 2020-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-18

Study Completion Date

2019-01-15

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.

Conditions

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Idiopathic Pulmonary Fibrosis Hypoxemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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).

Group Type EXPERIMENTAL

Oxymizer® pendant nasal cannula

Intervention Type DEVICE

Supplemental oxygen is provided by an Oxymizer pendant nasal cannula.

conventional nasal cannula

Intervention Type DEVICE

Supplemental oxygen is provided by a conventional nasal cannula.

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.

Group Type EXPERIMENTAL

Oxymizer® pendant nasal cannula

Intervention Type DEVICE

Supplemental oxygen is provided by an Oxymizer pendant nasal cannula.

conventional nasal cannula

Intervention Type DEVICE

Supplemental oxygen is provided by a conventional nasal cannula.

Interventions

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Oxymizer® pendant nasal cannula

Supplemental oxygen is provided by an Oxymizer pendant nasal cannula.

Intervention Type DEVICE

conventional nasal cannula

Supplemental oxygen is provided by a conventional nasal cannula.

Intervention Type DEVICE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Schön Klinik Berchtesgadener Land

OTHER

Sponsor Role collaborator

Klaus Kenn

OTHER

Sponsor Role lead

Responsible Party

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Klaus Kenn

Prof. Dr. med.

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Schön Klinik Berchtesgadener Land

Schönau am Königssee, , Germany

Site Status

Countries

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Germany

Other Identifiers

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IPF Oxymizer study II

Identifier Type: -

Identifier Source: org_study_id

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