Multiple Breath Nitrogen Washout in Healthy Volunteers

NCT ID: NCT03447418

Last Updated: 2021-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-06

Study Completion Date

2021-07-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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no treatment, open label

Group Type OTHER

Multiple breath nitrogen washout

Intervention Type PROCEDURE

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

Interventions

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Multiple breath nitrogen washout

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Femme Mère Enfant

Bron, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Philippe REIX, Pr

Role: CONTACT

427 85 54 70 ext. +33

Marie PERCEVAL

Role: CONTACT

427 85 59 87 ext. +33

Facility Contacts

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Philippe REIX, Pr

Role: primary

Other Identifiers

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69HCL18_0064

Identifier Type: -

Identifier Source: org_study_id

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