Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Adults

Completed

• Conditions: Cystic Fibrosis; Healthy

• Registration Number: NCT02368080
• 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 adults 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).

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-12
• Study Completion: 2014-01
• Study First Submitted: 2015-01-14
• Study First Submitted QC: 2015-02-13
• Study First Posted: 2015-02-20
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-29
• Last Update Posted: 2015-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

Inclusion Criteria

• Cystic fibrosis diagnosis

Exclusion Criteria

• 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
Functional residual capacity (FRC) ( the helium rebreathing technique (FRC He) with a "Jaeger Masterscreen" (Würzburg, Germany)	1 hour	FRC will be compared with a third device in a subset of 11 healthy adults : the helium rebreathing technique (FRC He) with a "Jaeger Masterscreen" (Würzburg, Germany)
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