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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02563210
Recruitment Status : Completed
First Posted : September 30, 2015
Last Update Posted : April 11, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

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.

Condition or disease Intervention/treatment Phase
Airway Obstruction Other: airway resistance measurement Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : October 19, 2015
Actual Primary Completion Date : May 29, 2017
Actual Study Completion Date : May 29, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Choking

Arm Intervention/treatment
Experimental: airway resistance measurement
interruption and plethysmography techniques airway resistance measurement at each routine visit
Other: airway resistance measurement
assessment of airway resistance




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. measure of bronchodilator response [ Time Frame: Day one ]
    Bronchodilator response is assessed with Rint and sRaw measurement



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Ages Eligible for Study:   3 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child 3 to 6 years aged

Exclusion Criteria:

  • Height below 90 centimeters
  • Opposition to participation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02563210


Locations
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France
CHRU de Brest
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Marie-Agnès METGES, Pr University Hospital of Brest
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02563210    
Other Study ID Numbers: ARC 36 (RB 15.181)
First Posted: September 30, 2015    Key Record Dates
Last Update Posted: April 11, 2019
Last Verified: June 2017
Additional relevant MeSH terms:
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Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases