Status:
UNKNOWN
Measurement of Expiratory Flow Variability for the Detection of Bronchospasm in Infants Using the Ventica® Device by Revenio
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Revenio Research
Conditions:
Healthy, Wheezing, Non Wheezing Acute Respiratory Episode
Eligibility:
All Genders
2-36 years
Brief Summary
Wheezing in infants and children less than 3 years of age children is a frequent feature that might be difficult to diagnose when only the caregivers reporting is available. Indeed, in this age group ...
Detailed Description
Decrease airway caliber induces airflow limitation which, in turn, will determine a decrease in the tidal breathing variability. While sleeping, tidal breathing variability will not be influenced by e...
Eligibility Criteria
Inclusion
- For all children, 2 to 36-months-olds, term birth (\> 37 ga), birth weight \> 3 Percentile, no hospitalisation for newborn respiratory distress, family aware of the use of the medical device, family of legal guardian consent to the study. According to the group, group 1: no history of chronic rhinitis, bronchiolitis or asthma, no respiratory allergy, no current acute disease, group 2: no history of chronic rhinitis, bronchiolitis or asthma, no respiratory allergy, no history of chronic rhinitis, bronchiolitis or asthma, no respiratory allergy, presence of current non-wheezing respiratory disease or fever, group 3: presence of current wheezing episode
Exclusion
- Tonsil hypertrophy with respiratory impact
- Clinical sleep apnea syndrome (snoring or apnea noted or breathing obstructed during sleep)
- Use of rapid onset bronchodilator for less than 8 hours (except for asthmatic infants included in an exacerbation)
- Anti-asthma treatment in progress (except for asthmatic infants included during an exacerbation)
- Known chronic cardio-respiratory or other pathology that may have a respiratory impact.
- Skin pathology preventing DM placement
- Patients with a pacemaker, continuous glucose monitor, or any other connected or implanted electronic or other medical device (e.g. ECG)
Key Trial Info
Start Date :
March 7 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 7 2024
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04702620
Start Date
March 7 2022
End Date
March 7 2024
Last Update
April 18 2022
Active Locations (1)
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1
Armand Trousseau Hospital
Paris, France, 75012