Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)

Study Overview
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Brief Summary
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This study will investigate the effects of a reservoir nasal cannula (Oxymizer®) compared to a conventional nasal cannula (CNC) in patients with idiopathic pulmonary fibrosis.

Detailed Description
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Patients will be recruited during a 3-week inpatient pulmonary rehabilitation program. They will perform the following three interventions on consecutive days and will repeat them after a week. During these days the time table for prescribed physical activities and therapies will be kept in a comparable fashion. The following 3 interventions will be performed in randomized order: Day A: The Patient wears a conventional nasal cannula for 12 h with oxygen flow rate as prescribed during ADL Day B: The Patient wears the Oxymizer® with prescribed oxygen flow rate for 12 h during ADL Day C: The patient wears the Oxymizer® with a flow rate reduced by 1l/min in comparison to the prescribed oxygen flow rate, for 12h The following week the same measurements will be repeated. The mean of the corresponding two measures will be calculated for each approach.

Official Title
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Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF)

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Device: Oxymizer® compared to CNC
* Device: Oxymizer® compared to CNC
* Device: Oxymizer® compared to CNC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IPF patients with indication for long term oxygen therapy ≥ 2l/min VC >30% and < 70% pred. Exclusion Criteria: failure to comply with study process acute infection

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxymizer® compared to CNC<br>From 7am to 7pm oxygen saturation is measured by a pulse oximeter. One day with conventional nasal cannula, one day with Oxymizer®, one day with Oxymizer® and reduced Oxygen flow (-1l/min). The order of these days is randomized in 6 groups. The intervention will be performed on consecutive days and twice during study period. | Device: Oxymizer® compared to CNC<br>* Oxygen Saturation measurement for 12 h with CNC<br>* Other names: Conventional Nasal Cannula (CNC);Device: Oxymizer® compared to CNC<br>* Oxygen Saturation measurement for 12 h with Oxymizer®<br>* Other names: Oxymizer;Device: Oxymizer® compared to CNC<br>* Saturation measurement for 12 h with Oxymizer® by reduced flow rate (-1l/min)<br>* Other names: Oxymizer with reduced flow rate (-1l/min);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in oxygen saturation between Oxymizer and conventional nasal cannula | Oxygen Saturation will be measured via pulseoxymetry for 12 hours. On 2 days, mean oxygen Saturation will be reported while using Oxymizer or a conventional nasal cannula, both with similar Oxygen flow. The difference of the mean Oxygen Saturation of 12 hours between both cannulae will be the Primary outcome. | day 1 to 13 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxymizer, Oxygen conserving device, Conventional nasal cannula (CNC), Idiopathic pulmonary fibrosis