Sensitivity of Forced Oscillation Technique in Children With Asthma and Normal Spirometry
NCT ID: NCT03755908
Last Updated: 2018-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
150 participants
OBSERVATIONAL
2018-12-31
2021-10-31
Brief Summary
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Study hypothesis: The forced oscillation technique (FOT) will show airway obstruction in asthmatic children with normal spirometry pointing out its advantage in measuring AW obstruction in this population.
We will conduct a prospective observational study in 6-18 years old children with the diagnosis of asthma and a normal spirometry results.
Each subject will undergo evaluation including: asthma control questionnaire, spirometry, FOT and Fractional exhaled nitric oxide (FeNO) to assess the sensitivity of FOT in diagnosing airway obstruction in this circumstances.
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Detailed Description
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The objective of this study is to assess the sensitivity of FOT in children with asthma and normal spirometry.
Study design: this will be a prospective observational study. Population: 6-18 years old children visiting the pediatric pulmonary clinic at the investigators institution with the diagnosis of asthma and normal spirometry results (FEV1 \& FEV1/FVC \>80% and FEF25-75\>65%) either on treatment or before treatment.
Study protocol:
After obtaining written informed consent, participants will fill asthma control questionnaires. Family history and risk factors for asthma will be reviewed. Data on blood eosinophils and skin prick test for allergy will be collected from the medical files. Medication (controller and reliever) will be also documented.
FOT will be measured using the TremoFlo C-100 Airwave Oscillometry System (Thorasys , Montreal, Quebec, Canada). R5, R20, R5-20 (resistances at the reported frequency), X5 (reactance at 5hz), AX5 (reactance area at 5hz), Fres (resonance frequency) will be reported.
Fractional exhaled nitric oxide (FeNO) will be measured using the single breath exhalation technique.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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asthmatic children
Children with the diagnosis of asthma and normal spirometry results. Each subject will undergo evaluation including: asthma control questionnaire, spirometry, FOT and Fractional exhaled nitric oxide (FeNO).
Forced oscillation technique (FOT)
FOT will be measured using the TremoFlo C-100 Airwave Oscillometry System (Thorasys , Montreal, Quebec, Canada). R5, R20, R5-20 (resistances in the reported frequency), X5 (reactance in 5hz) and Ax5 (reactance area in 5hz) will be reported.
Interventions
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Forced oscillation technique (FOT)
FOT will be measured using the TremoFlo C-100 Airwave Oscillometry System (Thorasys , Montreal, Quebec, Canada). R5, R20, R5-20 (resistances in the reported frequency), X5 (reactance in 5hz) and Ax5 (reactance area in 5hz) will be reported.
Eligibility Criteria
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Inclusion Criteria
* Must be able to perform spirometry and FOT tests
* Normal spirometry results (FEV1 \& FEV1/FVC \>80% and FEF25-75\>65%)
Exclusion Criteria
* Severe chronic medical condition such as heart failure, neuromuscular disease etc.
6 Years
18 Years
ALL
No
Sponsors
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Rambam Health Care Campus
OTHER
Responsible Party
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Principal Investigators
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Lea Bentur, MD
Role: PRINCIPAL_INVESTIGATOR
Rambam Medical Center, Haifa, Israel
Locations
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Rambam Medical Center
Haifa, , Israel
Countries
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Central Contacts
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Other Identifiers
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0384-18-RMB-CTIL
Identifier Type: -
Identifier Source: org_study_id
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