Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients
1 other identifier
observational
45
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2011
CompletedFirst Posted
Study publicly available on registry
August 11, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedAugust 11, 2011
August 1, 2011
6 months
August 2, 2011
August 10, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
cough count (increase or decrease by more then 1 cough event or unchanged) in response to treatment
Duration (from beginning to end) of emergency department stay. On average, 3 hours.
Study Arms (3)
Group 1: Patients ages 0 - 3
Group 2: Patients ages 3 - 7
Group 3: Patients ages 7 - 15
Eligibility Criteria
Pediatric emergency room patients ages 0 - 15 with shortness of breath upon arrival at the hospital
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- KarmelSonix Ltd.lead
- Hadassah Medical Organizationcollaborator
Study Sites (1)
Hadassah Medical Center Mt. Scopus
Jerusalem, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eitan Kerem, Prof.
Hadassah Medical Center Mt. Scopus, Jerusalem, Israel
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 2, 2011
First Posted
August 11, 2011
Study Start
September 1, 2011
Primary Completion
March 1, 2012
Study Completion
September 1, 2012
Last Updated
August 11, 2011
Record last verified: 2011-08