NCT01414322UnknownNot Applicable
Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients
KarmelSonix Ltd.1 site in 1 country45 target enrollmentStarted: September 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- increase or decrease of WheezeRate (the proportion of wheezing in the respiratory cycle)
Study Overview
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.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 15 Years (Child)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
increase or decrease of WheezeRate (the proportion of wheezing in the respiratory cycle)
Time Frame: 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 Outcomes
- 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.)
Investigators
Study Sites (1)
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