Asthma in Children, Bronchiolitis, Bronchitis
Conditions
Keywords
wheeze, rhonchus
Brief summary
The WheezeScan sensitivity and specificity are set to statistically prove equal to or higher values than the predicate PulmoTrack device model 2020.
Interventions
None listed
Sponsors
University of Wisconsin, Madison
Children's Hospital Medical Center, Cincinnati
University of Chicago
Omron Healthcare Co., Ltd.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
3 Months to 8 Years
Healthy volunteers
No
Inclusion criteria
Mild to moderate diagnosed or suspected asthma, bronchitis, or bronchiolitis patients who meet all of the following criteria are considered as eligible. 1. Does the subject have mild to moderate diagnosed or suspected asthma, bronchitis, or bronchiolitis? 2. Is the subject between the ages of 3 months to 8 years old? 3. Is the parent or legal guardian available, and capable and willing to give a consent on the child's behalf.
Exclusion criteria
The subjects will be excluded from the study, if they have any of the following criteria. 1. Does the subject have skin rashes or wounds on the chest? 2. Does the subject have known allergies or irritant contact dermatitis or having hypersensitive skin? 3. Does the subject have a defibrillator and/or pacemaker (which could interfere with the sounds to be detected)? 4. Does the subject have an allergy to disinfecting alcohol? 5. Does the subject have wheezes caused by not asthma, such as reflux esophagitis, pneumonia, vocal cord dysfunction, Tracheomatosis? 6. Does the subject have a heavy runny nose? 7. Is it difficult to hear auscultation due to the subject fussing, crying or vocalizing at data collection? 8. Is the subject having difficulty breathing or having severe symptoms? 9. Was the subject enrolled more than once for the same resulted breath sounds? * Note: The subject maybe enrolled once per arm (once wheezing, once non-wheezing).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the sensitivity and specificity of the Omron WheezeScan device | Novemver 1, 2019 ~ November 30, 2021 | The WheezeScan device will be compared to the gold standard, auscultation, which will be performed by a physician or a qualified healthcare professional with a minimum of 3 years' experience. All breath sounds will be recorded for comparison in case of discrepancy. |
Countries
United States
Contacts
Primary ContactNaoto Ohgami
Backup ContactKatie May
Outcome results
None listed