Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics

Recruiting

• Conditions: Traumatic Brain Injury

• Registration Number: NCT06697808
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

To improve patient selection for head CT, a safe and high sensitivity screening neuroimaging modality is needed. Currently many clinicians must make treatment decisions based solely on the patients clinical exam, which has low sensitivity and specificity and low inter-rater reliability. This study is being done to learn more about B-mode cranial point-of-care ultrasound (cPOCUS). Ultrasound has several advantages. It is a safe, non- invasive, low-cost, fast and portable bedside tool without ionizing radiation exposure.

Detailed Description

B-mode cranial point-of-care ultrasound (cPOCUS) being used in this study is an innovative, low-risk, inexpensive solution for diagnosing clinically significant intracranial pathology in children presenting with blunt head trauma which could be valuable for resource- austere environments. Traumatic brain injury remains a leading cause of death and disability in children. In addition, those who present with suspected acute brain injury in resource-austere environments may be at high risk of long-term neurologic sequelae or death. Early neuroimaging to identify traumatic brain injury and guide interventions is key to preventing their neurologic morbidity and mortality.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-11-18
• Study First Submitted QC: 2024-11-18
• Study First Posted: 2024-11-20
• Study Start: 2024-11-24
• Last Update Submitted: 2025-01-02
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-10
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

• Patients requiring a head computed tomography (CT) as the standard of care
• Seen in the pediatric Emergency Department or Pediatric Intensive Care Unit at Atrium Health Wake Forest Brenner Children's Hospital or Levine Children's Hospital

Exclusion Criteria

• Patients with open skull fractures
• Previous hemicraniectomy
• Existing surgical defect in the skull
• Patients being transitioned to comfort care

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic Accuracy of Cranial Point-of-Care Ultrasound	Day 1	The diagnostic accuracy of cranial point-of-care ultrasound (cPOCUS) is reported reported by comparing the counts of positive and negative findings for the two imaging modalities with sensitivity, specificity, positive predictive value and negative predictive value.

Trial Locations

Locations (1)

Atrium Health Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States