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NCT02563210 Clinical Trial

Airway Resistance Measurement in Children 3 to 6 Years of Age

Airway Obstruction Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02563210
Other study ID # ARC 36 (RB 15.181)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 19, 2015
Est. completion date May 29, 2017

Study information
Verified date June 2017
Source University Hospital, Brest
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date May 29, 2017
Est. primary completion date May 29, 2017
Accepts healthy volunteers No
Gender All
Age group 3 Years to 6 Years
Eligibility Inclusion Criteria:

- Child 3 to 6 years aged

Exclusion Criteria:

- Height below 90 centimeters

- Opposition to participation

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• airway resistance measurement
assessment of airway resistance

Locations
Country Name City State
France CHRU de Brest Brest

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Day one
Secondary measure of bronchodilator response Bronchodilator response is assessed with Rint and sRaw measurement Day one
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