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

Asthma Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01414322
• Other study ID #: KSI-IL-HHZ-ER-01
• Status: Not yet recruiting
• Phase: N/A
• First received: August 2, 2011
• Last updated: August 10, 2011
• Start date: September 2011
• Est. completion date: September 2012

Study information

• Verified date: August 2011
• Source: KarmelSonix Ltd.
• Contact: Noam Gavriely, MD PhD
• Phone: +972 54 466 1337
• Email: noam[@]karmelsonix.com
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: September 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 15 Years

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Bronchiolitis

Locations

Country	Name	City	State
Israel	Hadassah Medical Center Mt. Scopus	Jerusalem

Sponsors (2)

Lead Sponsor	Collaborator
KarmelSonix Ltd.	Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No