NCT05726201

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 31, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

July 23, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

2.2 years

First QC Date

January 31, 2023

Last Update Submit

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

ultrasoundDIAGNOSTIC_TEST

Point-Of-Care Ultrasound (POCUS) As an Early Screening Tool for Diagnosing Skull Fractures In Children With Mild Closed Head Injuries

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

* 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

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Hala S Abdel-Ghaffar, MD

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Zeinab M Abd-Elatiff, MD

    Suez Canal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

omar I abdelsalam, Master

CONTACT

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

Locations