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:
KarmelSonix Ltd.
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 2, 2011 | ||||||||
| Last Updated Date | August 10, 2011 | ||||||||
| Start Date ICMJE | September 2011 | ||||||||
| Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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). |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01414322 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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). |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Documentation of Continuous Wheeze and Cough Dynamics in Pediatric ER SOB Patients | ||||||||
| Official Title ICMJE | Not Provided | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Pediatric emergency room patients ages 0 - 15 with shortness of breath upon arrival at the hospital |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 45 | ||||||||
| Estimated Completion Date | September 2012 | ||||||||
| Estimated Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | up to 15 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Israel | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01414322 | ||||||||
| Other Study ID Numbers ICMJE | KSI-IL-HHZ-ER-01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Noam Gavriely, MD PhD, KarmelSonix Ltd. | ||||||||
| Study Sponsor ICMJE | KarmelSonix Ltd. | ||||||||
| Collaborators ICMJE | Hadassah Medical Organization | ||||||||
| Investigators ICMJE |
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| Information Provided By | KarmelSonix Ltd. | ||||||||
| Verification Date | August 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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