Asthma, Bronchiolitis
Conditions
Brief summary
Phenotype characterization of shortness of breath of pediatric emergency room patients by objective wheeze and cough monitoring improves diagnostic and severity assessment accuracy and correlates with overall patient outcomes.
Interventions
None listed
Sponsors
Hadassah Medical Organization
KarmelSonix Ltd.
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 15 Years
Healthy volunteers
No
Inclusion criteria
* patient is admitted to the ER with shortness of breath * patient management is according to standardized protocols used in Hadassah Mt. Scopus pediatric emergency department including: * asthma management protocol * bronchiolitis management protocol * ages 0 - 15 * patient's parent/guardian is able to comprehend and give informed consent for participating in the study
Exclusion criteria
* patient has received any dose of inhaled bronchodilators in the hour prior to enrollment * patient has received oral or IV steroids in a time window of 30 minutes to 5 hours prior to enrollment * ventilated patients, while ventilated * chest skin lesions * cystic fibrosis * hemodynamic instability * patient's parent/guardian objects to the study protocol * concurrent participation in any other clinical study * physician objection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| increase or decrease of WheezeRate (the proportion of wheezing in the respiratory cycle) | Duration (from beginning to end) of emergency department stay. On average, 3 hours. | Characterize the dynamic pattern of wheeze rate (increase or decrease by 50% or unchanged) within 30 minutes of onset of therapy, and to correlate pattern to clinical diagnoses, severity assessment (accessory muscle use, oxygen saturation, inspiratory/expiratory ratio, severity of wheezing), and outcome (admission versus discharge). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| cough count (increase or decrease by more then 1 cough event or unchanged) in response to treatment | Duration (from beginning to end) of emergency department stay. On average, 3 hours. | cough count (increase or decrease by more then 1 cough event or unchanged) in response to treatment and to correlate pattern to clinical diagnoses, severity assessment (accessory muscle use, oxygen saturation, inspiratory/expiratory ratio, severity of wheezing), and outcome (admission versus discharge). |
Countries
Israel
Contacts
Primary ContactNoam Gavriely, MD PhD
Backup ContactEzekiel Balouka, MSc
Outcome results
None listed