Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients

• Conditions: Bronchiolitis; Asthma

• Registration Number: NCT01414322
• Lead Sponsor: KarmelSonix Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-08
• Study First Submitted: 2011-08-02
• Study First Submitted QC: 2011-08-10
• Last Update Submitted: 2011-08-10
• Study First Posted: 2011-08-11
• Last Update Posted: 2011-08-11
• Study Start: 2011-09
• Primary Completion: 2012-03
• Study Completion: 2012-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Hadassah Medical Center Mt. Scopus; 🇮🇱 Jerusalem, Israel