Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Children
- Conditions
- Cystic FibrosisHealthy
- Registration Number
- NCT02378454
- Lead Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Brief Summary
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
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Cystic fibrosis diagnosis
- Respiratory infection within 3 weeks
- Chronically infected with methicillin-resistant Staphylococcus aureus or Burkholderia Cepacia
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Lung Clearance Index (LCI) 1 hour
- Secondary Outcome Measures
Name Time Method Spirometry 20 minutes 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
Discriminative ability of LCI of each device (assessed by evaluating the proportion of patients with normal spirometry but high LCI with each device) 1 hour Difference in discriminative ability between devices will be assessed by evaluating the proportion of patients with normal spirometry but high LCI with each device
Trial Locations
- Locations (1)
Cliniques universitaires Saint-Luc
🇧🇪Brussels, Belgium