Clinical trial NCT03411876: Effects of Oxymizer Pendant Cannula Versus Conventional Nasal Cannula During Endurance Shuttle Walk Tests in Hypoxemic Patients With Idiopathic Pulmonary Fibrosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Hypoxemia
Keywords: IPF
Oxymizer
oxygen conserving device
pulmonary disease
Lead sponsor: Schön Klinik Berchtesgadener Land
Sponsor class: OTHER
Collaborators: name: Schön Klinik Berchtesgadener Land
First posted: 2018-01-26
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Endurance shuttle walk test distance
timeFrame: at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
Secondary outcomes:
measure: oxygen saturation
timeFrame: at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
measure: heart rate
timeFrame: at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
measure: breathing frequency
timeFrame: at baseline, at isotime of endurance shuttle walk test and at the end (maximal 20 min) of endurance shuttle walk test
measure: carbon dioxide pressure
timeFrame: at baseline, at isotime of endurance shuttle walk test and at the end (maximum 20 min) of endurance shuttle walk test
measure: time to desaturation
timeFrame: From beginning of endurance shuttle walk test until the oxygen saturation reaches defined thresholds, or ESWT reaches maximum time frame of 20 minutes
Other outcomes:
Locations:
city: Schönau Am Königssee
country: Germany
facility: Schön Klinik Berchtesgadener Land
Study officials:
References: