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Airway Resistance Measurement in Children 3 to 6 Years of Age (ARC36)

Primary Purpose

Airway Obstruction

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
airway resistance measurement
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Airway Obstruction

Eligibility Criteria

3 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Child 3 to 6 years aged

Exclusion Criteria:

  • Height below 90 centimeters
  • Opposition to participation

Sites / Locations

  • CHRU de Brest

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

airway resistance measurement

Arm Description

interruption and plethysmography techniques airway resistance measurement at each routine visit

Outcomes

Primary Outcome Measures

airway resistance measure by interruption technique (Rint)
Rint is performed using Spiroteq Dyn'R during a 100 ms occlusion and calculated using the linear back extrapolation method

Secondary Outcome Measures

measure of bronchodilator response
Bronchodilator response is assessed with Rint and sRaw measurement

Full Information

First Posted
September 15, 2015
Last Updated
April 10, 2019
Sponsor
University Hospital, Brest
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1. Study Identification

Unique Protocol Identification Number
NCT02563210
Brief Title
Airway Resistance Measurement in Children 3 to 6 Years of Age
Acronym
ARC36
Official Title
Interrupter Technique and Plethysmography Airway Resistance Measurement: Comparison of These Two Techniques for the Diagnosis of Airway Obstruction Diagnosis and Bronchodilation Response in Children 3 to 6 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 19, 2015 (Actual)
Primary Completion Date
May 29, 2017 (Actual)
Study Completion Date
May 29, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
In preschool aged children, the most suitable techniques to assess airway obstruction is debit interruption technic (Rint) and plethysmographic measure of specific airway resistance (sRaw). Even if Rint is easily and routinely performed, it also includes a component of lung tissue and chest wall resistance as well as respiratory tissue viscoelasticity. sRaw seems to be better for discriminating airway obstruction. These two techniques will be compared in terms of concordance in the diagnosis of pulmonary obstruction and bronchodilator response.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Airway Obstruction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
airway resistance measurement
Arm Type
Experimental
Arm Description
interruption and plethysmography techniques airway resistance measurement at each routine visit
Intervention Type
Other
Intervention Name(s)
airway resistance measurement
Intervention Description
assessment of airway resistance
Primary Outcome Measure Information:
Title
airway resistance measure by interruption technique (Rint)
Description
Rint is performed using Spiroteq Dyn'R during a 100 ms occlusion and calculated using the linear back extrapolation method
Time Frame
Day one
Secondary Outcome Measure Information:
Title
measure of bronchodilator response
Description
Bronchodilator response is assessed with Rint and sRaw measurement
Time Frame
Day one

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Child 3 to 6 years aged Exclusion Criteria: Height below 90 centimeters Opposition to participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Agnès METGES, Pr
Organizational Affiliation
University Hospital of Brest
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU de Brest
City
Brest
ZIP/Postal Code
29609
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
31945475
Citation
Mauger-Hamel P, Du Boisbaudry C, Leon K, Alavi Z, Giroux-Metges MA. Relationship between baseline and post-bronchodilator interrupter resistance and specific airway resistance in preschool children. Ann Allergy Asthma Immunol. 2020 Apr;124(4):366-372. doi: 10.1016/j.anai.2020.01.003. Epub 2020 Jan 13.
Results Reference
derived

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Airway Resistance Measurement in Children 3 to 6 Years of Age

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