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

Not Applicable

Completed

• Conditions: Hypoxemia; Idiopathic Pulmonary Fibrosis
• Interventions: Device: Oxymizer® pendant nasal cannula; Device: conventional nasal cannula

• Registration Number: NCT03411876
• Lead Sponsor: Klaus Kenn

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.

Study Timeline

• Study Start: 2018-01-18
• Study First Submitted: 2018-01-18
• Study First Submitted QC: 2018-01-25
• Study First Posted: 2018-01-26
• Primary Completion: 2019-01-15
• Study Completion: 2019-01-15
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-15
• Last Update Posted: 2020-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First ESWT with CNC, second ESWT with Oxymizer	Oxymizer® pendant nasal cannula	Patients in this study arm first perform the first endurance shuttle walk test (ESWT) with the CNC and the second ESWT with the Oxymizer.
First ESWT with Oxymizer, second ESWT with CNC	Oxymizer® pendant nasal cannula	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).
First ESWT with CNC, second ESWT with Oxymizer	conventional nasal cannula	Patients in this study arm first perform the first endurance shuttle walk test (ESWT) with the CNC and the second ESWT with the Oxymizer.
First ESWT with Oxymizer, second ESWT with CNC	conventional nasal cannula	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).

Primary Outcome Measures

Name	Time	Method
Endurance shuttle walk test distance	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 Outcome Measures

Name	Time	Method
heart rate	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
carbon dioxide pressure	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
oxygen saturation	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
breathing frequency	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
time to desaturation	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

Trial Locations

Locations (1)

Schön Klinik Berchtesgadener Land; 🇩🇪 Schönau Am Königssee, Germany