(POCUS) As an Early Screening Tool for Diagnosing Skull Fractures in Children
Point-Of-Care Ultrasound (POCUS) As an Early Screening Tool for Diagnosing Skull Fractures In Children With Mild Closed Head Injuries
1 other identifier
observational
250
1 country
1
Brief Summary
This study aims to evaluate the accuracy of POCUS as a screening tool for early diagnosis of skull fractures in children with mild closed head injuries admitted to the emergency department. The results would aid the emergency physicians to speed up the management and reduce the cost of diagnosing skull fractures and TBI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2023
CompletedFirst Posted
Study publicly available on registry
February 13, 2023
CompletedStudy Start
First participant enrolled
July 23, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2025
CompletedJuly 25, 2023
July 1, 2023
2.2 years
January 31, 2023
July 23, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
main
Evaluate the diagnostic accuracy (sensitivity and specificity) of point of-care ultrasound (POCUS) as a screening tool for identifying and early diagnosis skull fractures in children with mild closed head trauma
3 years
Secondary Outcomes (4)
Incidence
3 years
PECARN predictive rule
3 years
Computed Tomography Scanning skull
3 years
Agreement ratio
3 years
Interventions
Point-Of-Care Ultrasound (POCUS) As an Early Screening Tool for Diagnosing Skull Fractures In Children With Mild Closed Head Injuries
Eligibility Criteria
* Age group 2 - 18 years old * Both genders * Blunt head trauma within 24hours of admission to the ED. * Glasgow Coma Scale scores of 14 to 15. * Localizing evidence of scalp trauma (cephalohematoma, focal pain, deformity)
You may qualify if:
- Age group 2 - 18 years old
- Both genders
- Blunt head trauma within 24hours of admission to the ED.
- Glasgow Coma Scale scores of 14 to 15.
- Localizing evidence of scalp trauma (cephalohematoma, focal pain, deformity)
You may not qualify if:
- Patients who are less than 2 years old or more than 18 years old
- Patients with open head wounds
- Ventricular shunts
- Bleeding disorders
- Known brain tumors
- Pre-existing neurological disorders complicating assessment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Omar Ibrahim Abdelsalam
Asyut, Asyut Governorate, 71515, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hala S Abdel-Ghaffar, MD
Assiut University
- PRINCIPAL INVESTIGATOR
Zeinab M Abd-Elatiff, MD
Suez Canal University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Days
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Anesthesiology and Intensive Care Faculty of Medicine
Study Record Dates
First Submitted
January 31, 2023
First Posted
February 13, 2023
Study Start
July 23, 2023
Primary Completion
October 1, 2025
Study Completion
October 30, 2025
Last Updated
July 25, 2023
Record last verified: 2023-07