Multiple Breath Nitrogen Washout in Healthy Volunteers

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03447418

Acronym

HV-LCI

Enrollment

191

Registered

2018-02-27

Start date

2018-07-06

Completion date

2021-07-31

Last updated

2021-01-27

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

Conditions

Healthy

Keywords

Lung Clearance Index, Breath Nitrogen Washout, Healthy subjects

Brief summary

This study is designed to establish reference values of multiple breath nitrogen washout indexes in an healthy population of volunteers (from childhood to adulthood)

Interventions

PROCEDUREMultiple breath nitrogen washout

Lung Clearance Index (LCI) will be performed in healthy volunteers with a multiple breath nitrogen washout device.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Informed consent by participant, parent, or legal guardian * Healthy subjects with a social insurance

Exclusion criteria

* History of a lung chronic disease * Premature birth (\<37th weeks of amenorrhea) * Acute lower respiratory viral infection within 3 weeks before Multiple Breath washout

Design outcomes

Primary

Measure	Time frame	Description
Lung Clearance Index 2.5% (LCI 2.5%) Value	hour 1	Multiple breath washout is a pulmonary function test that does not require patients' cooperation. It studies the number of lung volumes (turn-over) to clear a gaz such as nitrogen form the lungs. LCI 2,5 is most frequently reported outcome measure. It corresponds to the sum of the total expired lung volumes needed to decrease the initial gaz concretion to its 1/40th, divided by functional residual capacity. LCI can be measured in infant, preschoolers and thereafter. In order to obtain reproducible tests, three acceptable maneuvers are needed.

Secondary

Measure	Time frame	Description
Lung Clearance Index 5% (LCI 5%) Value	hour 1	—
Moment ratio M1/M0 Value	up to 1 hour	—
Moment ratio M0/M2 Value	up to 1 hour	—
Sacin value	hour 1	assessment of distal areas function
Scond value	hour 1	assessment of conductive areas function

Countries

France

Contacts

Primary ContactPhilippe REIX, Pr

philippe.reix@chu-lyon.fr427 85 54 70

Backup ContactMarie PERCEVAL

marie.perceval@chu-lyon.fr427 85 59 87

Outcome results

None listed

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