- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07826273
Cardiac Arrhythmias in Pediatric Emergency Department
Incidence and Outcome of Cardiac Arrhythmias Among Children in the Emergency Department at Assiut University Children Hospital
Study Overview
Status
Detailed Description
Cardiac arrhythmias are a significant concern in the pediatric emergency setting. This observational study will include children aged 1 month to 18 years presenting with symptoms suggestive of arrhythmia (palpitation, chest pain, syncope, dyspnea, or respiratory distress).
All participants will undergo full history, clinical examination, 12-lead ECG, and additional investigations as indicated (echocardiography, Holter, laboratory tests). Incidence of different arrhythmia types, clinical picture, and short-term outcomes will be recorded.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hossam H Abdel kader, Resident
- Phone Number: +20 11 22524212
- Email: Husam.18313179@med.aun.edu.eg
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age from 1 month to 18 years
- Presenting with palpitation, chest pain, syncope, dyspnea, or respiratory distress
- Written informed consent from parents or legal guardians
Exclusion Criteria:
- Age below 1 month
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
Single cohort: Children presenting to pediatric ED
Children aged 1 month to 18 years presenting to the Emergency Department with symptoms suggestive of cardiac arrhythmia who will undergo ECG and clinical assessment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of cardiac arrhythmias
Time Frame: Baseline
|
Proportion of children presenting to the pediatric emergency department who are diagnosed with cardiac arrhythmia based on 12-lead ECG.
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Types of arrhythmias
Time Frame: Baseline
|
Proportion of specific arrhythmia types (sinus tachycardia, supraventricular tachycardia, ventricular tachycardia, bradyarrhythmias, premature beats, and others) among diagnosed cases.
|
Baseline
|
|
Need for PICU admission
Time Frame: Baseline
|
Proportion of children with cardiac arrhythmia who require admission to the pediatric intensive care unit.
|
Baseline
|
|
Need for cardioversion
Time Frame: Baseline
|
Proportion of children who require electrical or pharmacological cardioversion.
|
Baseline
|
|
Mortality
Time Frame: At 30 days
|
Proportion of children with cardiac arrhythmia who die during the emergency department visit or hospital stay.
|
At 30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ghada O Elsedfy, prof, pediatrics Department, Assiut University Hospitals
Publications and helpful links
General Publications
- Clausen H, Theophilos T, Jackno K, Babl FE. Paediatric arrhythmias in the emergency department. Emerg Med J. 2012 Sep;29(9):732-7. doi: 10.1136/emermed-2011-200242. Epub 2011 Sep 21.
- Mariani MV, Pierucci N, Fanisio F, Laviola D, Silvetti G, Piro A, La Fazia VM, Chimenti C, Rebecchi M, Drago F, Miraldi F, Natale A, Vizza CD, Lavalle C. Inherited Arrhythmias in the Pediatric Population: An Updated Overview. Medicina (Kaunas). 2024 Jan 3;60(1):94. doi: 10.3390/medicina60010094.
- Hanash CR, Crosson JE. Emergency diagnosis and management of pediatric arrhythmias. J Emerg Trauma Shock. 2010 Jul;3(3):251-60. doi: 10.4103/0974-2700.66525.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pediatric-Arrhythmia-ED-Assiut
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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