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

This study is not yet open for participant recruitment.
Verified August 2011 by KarmelSonix Ltd.
Sponsor:
Collaborator:
Hadassah Medical Organization
Information provided by:
KarmelSonix Ltd.
ClinicalTrials.gov Identifier:
NCT01414322
First received: August 2, 2011
Last updated: August 10, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition
Asthma
Bronchiolitis

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by KarmelSonix Ltd.:

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: 45
Study Start Date: September 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group 1: Patients ages 0 - 3
Group 2: Patients ages 3 - 7
Group 3: Patients ages 7 - 15

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414322

Contacts
Contact: Noam Gavriely, MD PhD +972 54 466 1337 noam@karmelsonix.com
Contact: Ezekiel Balouka, MSc +972 52 312 1098 ezekiel@karmelsonix.com

Locations
Israel
Hadassah Medical Center Mt. Scopus Not yet recruiting
Jerusalem, Israel
Principal Investigator: Eitan Kerem, Prof.            
Sponsors and Collaborators
KarmelSonix Ltd.
Hadassah Medical Organization
Investigators
Principal Investigator: Eitan Kerem, Prof. Hadassah Medical Center Mt. Scopus, Jerusalem, Israel
  More Information

No publications provided

Responsible Party: Noam Gavriely, MD PhD, KarmelSonix Ltd.
ClinicalTrials.gov Identifier: NCT01414322     History of Changes
Other Study ID Numbers: KSI-IL-HHZ-ER-01
Study First Received: August 2, 2011
Last Updated: August 10, 2011
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Asthma
Bronchiolitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bronchitis
Respiratory Tract Infections

ClinicalTrials.gov processed this record on June 17, 2013