HV-LCI: Multiple Breath Nitrogen Washout in Healthy Volunteers

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03447418
• Collaborator: (none)
• Enrollment: 191
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 35.8
• Patients Per Site Per Month: 5.3

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Healthy	Procedure: Multiple breath nitrogen washout	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 191 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Multiple Breath Nitrogen Washout in Healthy Volunteers
• Actual Study Start Date: Jul 6, 2018
• Anticipated Primary Completion Date: Jul 1, 2021
• Anticipated Study Completion Date: Jul 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Lung Clearance Index 5% (LCI 5%) Value [hour 1]

2. Moment ratio M1/M0 Value [up to 1 hour]

3. Moment ratio M0/M2 Value [up to 1 hour]

4. Sacin value [hour 1]

   assessment of distal areas function

5. Scond value [hour 1]

   assessment of conductive areas function

Eligibility Criteria

Criteria

• Ages Eligible for Study: 3 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital Femme Mère Enfant	Bron		France

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT03447418
• Other Study ID Numbers: 69HCL18_0064
• First Posted: Feb 27, 2018
• Last Update Posted: Jan 27, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Hospices Civils de Lyon: Lung Clearance Index; Breath Nitrogen Washout; Healthy subjects

Study Results

No Results Posted as of Jan 27, 2021