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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cystic fibrosis adults (CF) | No treatment, comparison of LCI values obtained with two devices |
| |
| Healthy adults (HC) | No treatment, comparison of LCI values obtained with two devices Free of respiratory disease or others diseases likely to disturb respiratory system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D" | Device | Healthy and Cystic Fibrosis participants will perform the same day MBWN2 tests in duplicate with each device. |
| Measure | Description | Time Frame |
|---|---|---|
| Lung Clearance Index (LCI) | 1 hour |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Subject's preference | Just after the completion of the tests, subjects will be asked to answer which one of the device they most preferred (i.e.: device A or device B or no preference). | 1 hour |
Inclusion Criteria:
Exclusion Criteria:
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CF : primary care clinic HC : community sample
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| Name | Affiliation | Role |
|---|---|---|
| Patrick Lebecque, MD, PhD | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Study Director |
| William Poncin, PhD student | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Principal Investigator |
| Anne-Sophie Aubriot, PhD student | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliniques universitaires Saint-Luc | Brussels | 1200 | Belgium |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| 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 |
| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |