Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by KarmelSonix Ltd..
Recruitment status was Not yet recruiting
Hadassah Medical Organization
Information provided by:
First received: August 2, 2011
Last updated: August 10, 2011
Last verified: August 2011
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.
||Time Perspective: Prospective
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
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:
- cough count (increase or decrease by more then 1 cough event or unchanged) in response to treatment [ Time Frame: Duration (from beginning to end) of emergency department stay. On average, 3 hours. ] [ Designated as safety issue: No ]
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).
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||March 2012 (Final data collection date for primary outcome measure)
Group 1: Patients ages 0 - 3
Group 2: Patients ages 3 - 7
Group 3: Patients ages 7 - 15
|Ages Eligible for Study:
||up to 15 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Pediatric emergency room patients ages 0 - 15 with shortness of breath upon arrival at the hospital
- 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01414322
|Hadassah Medical Center Mt. Scopus
|Jerusalem, Israel |
|Principal Investigator: Eitan Kerem, Prof. |
Hadassah Medical Organization
||Eitan Kerem, Prof.
||Hadassah Medical Center Mt. Scopus, Jerusalem, Israel
No publications provided
||Noam Gavriely, MD PhD, KarmelSonix Ltd.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 2, 2011
||August 10, 2011
||Israel: Israeli Health Ministry Pharmaceutical Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on August 19, 2014
Respiratory Tract Diseases
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Infections