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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03411876
Acronym
IPF/Oxymizer2
Enrollment
22
Registered
2018-01-26
Start date
2018-01-18
Completion date
2019-01-15
Last updated
2020-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis, Hypoxemia

Keywords

IPF, Oxymizer, oxygen conserving device, pulmonary disease

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.

Interventions

DEVICEOxymizer® pendant nasal cannula

Supplemental oxygen is provided by an Oxymizer pendant nasal cannula.

Supplemental oxygen is provided by a conventional nasal cannula.

Sponsors

Schön Klinik Berchtesgadener Land
CollaboratorOTHER
Klaus Kenn
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Endurance shuttle walk test distanceat baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk testDistance patients walk during an endurance shuttle walk test

Secondary

MeasureTime frameDescription
oxygen saturationat baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk testmeasured by Sentec Digital Monitoring System
heart rateat baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk testmeasured by Sentec Digital Monitoring System
breathing frequencyat baseline, at isotime of endurance shuttle walk test and at the end (maximal 20 min) of endurance shuttle walk testmeasured by NoxT3 device
carbon dioxide pressureat baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk testtranscutaneously carbon dioxide pressure measured by Sentec Digital Monitoring System
time to desaturationFrom beginning of endurance shuttle walk test until the oxygen saturation reaches defined thresholds, or ESWT reaches maximum time frame of 20 minutestime (seconds) is measured until oxygen saturation drops below 90% or 85 % respectively

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026