Multiple Breath Nitrogen Washout in Healthy Volunteers (HV-LCI)

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

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Procedure: Multiple breath nitrogen washout

• Study Type: Interventional
• Enrollment (Anticipated): 191
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France
    • Recruiting
    • Hopital Femme Mere Enfant
    • Contact: Philippe REIX, Pr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: no treatment, open label	Procedure: Multiple breath nitrogen washout; Lung Clearance Index (LCI) will be performed in healthy volunteers with a multiple breath nitrogen washout device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung Clearance Index 2.5% (LCI 2.5%) Value	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.	hour 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	assessment of distal areas function	hour 1
Scond value	assessment of conductive areas function	hour 1

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 6, 2018
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): July 1, 2021

Study Registration Dates

• First Submitted: February 19, 2018
• First Submitted That Met QC Criteria: February 26, 2018
• First Posted (ACTUAL): February 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 27, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Healthy subjects; Lung Clearance Index; Breath Nitrogen Washout
• Other Study ID Numbers: 69HCL18_0064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No