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

Idiopathic Pulmonary Fibrosis Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411876
• Other study ID #: IPF Oxymizer study II
• Status: Completed
• Phase: N/A
• Start date: January 18, 2018
• Est. completion date: January 15, 2019

Study information

• Verified date: April 2020
• Source: Schön Klinik Berchtesgadener Land
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: January 15, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Hypoxemia
• Hypoxia
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Device:
• Oxymizer® pendant nasal cannula
Supplemental oxygen is provided by an Oxymizer pendant nasal cannula.
• conventional nasal cannula
Supplemental oxygen is provided by a conventional nasal cannula.

Locations

Country	Name	City	State
Germany	Schön Klinik Berchtesgadener Land	Schönau Am Königssee

Sponsors (2)

Lead Sponsor	Collaborator
Klaus Kenn	Schön Klinik Berchtesgadener Land

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endurance shuttle walk test distance	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	oxygen saturation	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
Secondary	heart rate	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
Secondary	breathing frequency	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
Secondary	carbon dioxide pressure	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
Secondary	time to desaturation	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