Forced Oscillations Technique During a Metacholine Test in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Airway Oscillation System.
- Who it may be relevant to
- Registry conditions: Asthma in Children. Basic parameters: 6 years — 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Interest of Forced Oscillations During a Methacholine Test in Children
Overview
Asthma is the most common chronic lung disease in children. It affects more than 1 in 10 children in France. The methacholine bronchial challenge test (MBT) is indicated to assess the probability of asthma suggested by clinical symptoms by measuring the forced expiratory volume in one second (FEV1), after inhalation of a cumulative dose of methacholine. In children, the measurement of FEV1 requires a high level of cooperation from the child, which can be the source of false negatives or no result if this is not obtained. The objective of this study is to evaluate if the measurement of the respiratory function by the forced oscillations technique, allows to predict the variation of the FEV1 obtained
Interventions
- Procedure Airway Oscillation System
After each methacholine dose administred, respiratory function will be measured by forced oscillation
Primary outcome measures
- Change in lung impedance measurement [Time frame: During the procedure]
Secondary outcome measures (2)
- Average number of trials required for measurement of FEV1 with the spirometry technique [Time frame: During the procedure]
- Average number of trials required for impedance measurement by forced oscillation [Time frame: During the procedure]
Eligibility criteria
Inclusion criteria
- Age between 6 and 16 years
- FEV1 > 60%
- Child referred to the pulmonary function test laboratory for a non-specific bronchial hyperactivity test with methacholine
- Child under treatment with inhaled corticosteroids stopped for at least 3 weeks
- Oral consent from the child and at least one of the legal representatives
- Child affiliated or benefiting from a social security plan
Exclusion criteria
- Use of a short-acting beta-adrenergic bronchodilator within the last 6 hours or anticholinergic bronchodilator within the last 12 hours
- Use of a long-acting beta-adrenergic bronchodilator (licensed for use in children) in the past 36 hours
- Upper or lower respiratory tract infections within 3 weeks prior to inclusion
- Epilepsy under treatment
- Subject's participation in another interventional study that may alter respiratory function
- Patient unable to give consent, vulnerable
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- CHU de Montpellier — Montpellier
Identifiers
NCT: NCT05734261 · RECHMPL22_0504 · 2022-A02437-36 · RECHMPL22_0504