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

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 Overview

• Status: Unknown
• Conditions: Asthma; Bronchiolitis

• Study Type: Observational
• Enrollment (Anticipated): 45

Contacts and Locations

• Study Contact: Name: Noam Gavriely, MD PhD; Phone Number: +972 54 466 1337; Email: noam@karmelsonix.com
• Study Contact Backup: Name: Ezekiel Balouka, MSc; Phone Number: +972 52 312 1098; Email: ezekiel@karmelsonix.com

Study Locations

• Israel
  • Jerusalem, Israel
    • Hadassah Medical Center Mt. Scopus
    • Principal Investigator: Eitan Kerem, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Pediatric emergency room patients ages 0 - 15 with shortness of breath upon arrival at the hospital

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Group 1: Patients ages 0 - 3
Group 2: Patients ages 3 - 7
Group 3: Patients ages 7 - 15

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
increase or decrease of WheezeRate (the proportion of wheezing in the respiratory cycle)	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).	Duration (from beginning to end) of emergency department stay. On average, 3 hours.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cough count (increase or decrease by more then 1 cough event or unchanged) in response to treatment	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).	Duration (from beginning to end) of emergency department stay. On average, 3 hours.

Collaborators and Investigators

• Sponsor: KarmelSonix Ltd.
• Collaborators: Hadassah Medical Organization
• Investigators: Principal Investigator: Eitan Kerem, Prof., Hadassah Medical Center Mt. Scopus, Jerusalem, Israel

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Anticipated): March 1, 2012
• Study Completion (Anticipated): September 1, 2012

Study Registration Dates

• First Submitted: August 2, 2011
• First Submitted That Met QC Criteria: August 10, 2011
• First Posted (Estimate): August 11, 2011

Study Record Updates

• Last Update Posted (Estimate): August 11, 2011
• Last Update Submitted That Met QC Criteria: August 10, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis; Bronchiolitis
• Other Study ID Numbers: KSI-IL-HHZ-ER-01