- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02563210
Airway Resistance Measurement in Children 3 to 6 Years of Age (ARC36)
April 10, 2019 updated by: University Hospital, Brest
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
130
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Brest, France, 29609
- CHRU de Brest
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 6 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Child 3 to 6 years aged
Exclusion Criteria:
- Height below 90 centimeters
- Opposition to participation
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: airway resistance measurement
interruption and plethysmography techniques airway resistance measurement at each routine visit
|
assessment of airway resistance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
airway resistance measure by interruption technique (Rint)
Time Frame: Day one
|
Rint is performed using Spiroteq Dyn'R during a 100 ms occlusion and calculated using the linear back extrapolation method
|
Day one
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measure of bronchodilator response
Time Frame: Day one
|
Bronchodilator response is assessed with Rint and sRaw measurement
|
Day one
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Marie-Agnès METGES, Pr, University Hospital of Brest
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 19, 2015
Primary Completion (Actual)
May 29, 2017
Study Completion (Actual)
May 29, 2017
Study Registration Dates
First Submitted
September 15, 2015
First Submitted That Met QC Criteria
September 28, 2015
First Posted (Estimate)
September 30, 2015
Study Record Updates
Last Update Posted (Actual)
April 11, 2019
Last Update Submitted That Met QC Criteria
April 10, 2019
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARC 36 (RB 15.181)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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