Multiple Breath Nitrogen Washout in Healthy and Cystic Fibrosis Children

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02378454

Enrollment

100

Registered

2015-03-04

Start date

2014-08-31

Completion date

2015-04-30

Last updated

2015-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis, Healthy

Keywords

Lung Clearance Index, Cystic Fibrosis, Multiple Breath Nitrogen Washout

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).

Interventions

DEVICEComparison of two MBWN2 devices : EasyOne Pro Lab versus Exhalyzer D

Healthy and Cystic Fibrosis participants will perform the same day MBWN2 tests in duplicate with each device.

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

5 Years to 18 Years

Healthy volunteers

Yes

Inclusion criteria

* Cystic fibrosis diagnosis

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Lung Clearance Index (LCI)	1 hour

Secondary

Measure	Time frame	Description
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
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

Other

Measure	Time frame	Description
Subject's preference	1 hour	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).

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026