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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

Study Purpose

Aim of this study is to investigate the effects of an Oxymizer pendant nasal cannula in hypoxemic patients with idiopathic pulmonary fibrosis during walking.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03411876
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Klaus Kenn
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Germany
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Idiopathic Pulmonary Fibrosis, Hypoxemia

Additional Details

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.

Arms & Interventions

Arms

Experimental: 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).

Experimental: 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.

Interventions

Device: - Oxymizer® pendant nasal cannula

Supplemental oxygen is provided by an Oxymizer pendant nasal cannula.

Device: - conventional nasal cannula

Supplemental oxygen is provided by a conventional nasal cannula.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.