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Status unknownNCT03447418HV-LCIUpdated Jan 27, 2021

Multiple Breath Nitrogen Washout in Healthy Volunteers

An interventional study of Multiple breath nitrogen washout in Healthy, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-27.

Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
191
Allocation
Not applicable
Ages
3 Years and older
Sex
All
01

Study 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)

02

Conditions studied

  • Healthy

Keywords

  • Lung Clearance Index
  • Breath Nitrogen Washout
  • Healthy subjects
03

Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
191 participants (estimated)

Study arms

  • Other
    no treatment, open label

    Procedure: Multiple breath nitrogen washout

Interventions

  • ProcedureMultiple breath nitrogen washout

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

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: hour 1

Secondary outcomes

  1. Lung Clearance Index 5% (LCI 5%) Value

    Time frame: hour 1

  2. Moment ratio M1/M0 Value

    Time frame: up to 1 hour

  3. Moment ratio M0/M2 Value

    Time frame: up to 1 hour

  4. Sacin value

    assessment of distal areas function

    Time frame: hour 1

  5. Scond value

    assessment of conductive areas function

    Time frame: hour 1

06

Study locations

1 of 1 sites recruiting
  • Hôpital Femme Mère Enfant
    Bron, France
    • Philippe REIX, Pr · Contact
    Recruiting
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03447418
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Feb 27, 2018
Start date
Jul 6, 2018
Primary completion
Jul 2021 (estimated)
Completion
Jul 2021 (estimated)
Last update
Jan 27, 2021

Study contacts

Philippe REIX, Pr
Contact
philippe.reix@chu-lyon.fr
427 85 54 70 ext. +33
Marie PERCEVAL
Contact
marie.perceval@chu-lyon.fr
427 85 59 87 ext. +33

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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