Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Children

Study Overview
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Brief Summary
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This study compares the lung clearance index (LCI) in cystic fibrosis and healthy children obtained with two different multiple breath nitrogen washout (MBWN2) devices. Each participants will perform the test (LCI) in duplicate on each device.

Detailed Description
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Using nitrogen as the inert gas, there are currently two commercially available devices that offer the possibility to measure the LCI. However, comparison between them are lacking. The 2 MBWN2 devices are the EasyOne Pro Lab (ndd Medical Technologies, Zürich, Switzerland) and the Exhalyzer D (Eco Medics AG, Duernten, Switzerland).

Official Title
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Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Children: A Comparison of Two Commercially Available Devices

Conditions
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Cystic Fibrosis, Healthy

Intervention / Treatment
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* Device: Comparison of two MBWN2 devices : EasyOne Pro Lab versus Exhalyzer D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cystic fibrosis diagnosis Exclusion Criteria: Respiratory infection within 3 weeks Chronically infected with methicillin-resistant Staphylococcus aureus or Burkholderia Cepacia

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cystic fibrosis adults (CF)<br>No treatment, comparison of LCI values obtained with two devices | Device: Comparison of two MBWN2 devices : EasyOne Pro Lab versus Exhalyzer D<br>* Healthy and Cystic Fibrosis participants will perform the same day MBWN2 tests in duplicate with each device.<br>|
| Healthy adults (HC)<br>No treatment, comparison of LCI values obtained with two devices Free of respiratory disease or others diseases likely to disturb respiratory system. | Device: Comparison of two MBWN2 devices : EasyOne Pro Lab versus Exhalyzer D<br>* Healthy and Cystic Fibrosis participants will perform the same day MBWN2 tests in duplicate with each device.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Clearance Index (LCI) |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discriminative ability of LCI of each device (assessed by evaluating the proportion of patients with normal spirometry but high LCI with each device) | Difference in discriminative ability between devices will be assessed by evaluating the proportion of patients with normal spirometry but high LCI with each device | 1 hour | 
| Spirometry | Forced expired volume in one second (FEV1) and Forced expired flow at 25-75% of the forced vital capacity (FEF25-75) will be measured and correlated with LCI | 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lung Clearance Index, Cystic Fibrosis, Multiple Breath Nitrogen Washout