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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2011 by KarmelSonix Ltd..
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01414322
First Posted: August 11, 2011
Last Update Posted: August 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Hadassah Medical Organization
Information provided by:
KarmelSonix Ltd.
  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:


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. ]
    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. ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Noam Gavriely, MD PhD, KarmelSonix Ltd.
ClinicalTrials.gov Identifier: NCT01414322     History of Changes
Other Study ID Numbers: KSI-IL-HHZ-ER-01
First Submitted: August 2, 2011
First Posted: August 11, 2011
Last Update Posted: August 11, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections