Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Children

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Healthy; Cystic Fibrosis

Treatments: Device: Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D"

Study type: Observational

Funder types: Other

Identifiers

NCT02378454

StLuc MBWN2 02

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 patients

Sex: All

Ages: 5 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Cystic fibrosis diagnosis

Exclusion criteria

• Respiratory infection within 3 weeks
• Chronically infected with methicillin-resistant Staphylococcus aureus or Burkholderia Cepacia

Trial design

100 participants in 2 patient groups

Cystic fibrosis adults (CF)

Description:

No treatment, comparison of LCI values obtained with two devices

Treatment:

Device: Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D"

Healthy adults (HC)

Description:

No treatment, comparison of LCI values obtained with two devices Free of respiratory disease or others diseases likely to disturb respiratory system.

Treatment:

Device: Comparison of two MBWN2 devices : "EasyOne Pro Lab" versus "Exhalyzer D"