Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics (CUPID-Peds)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Traumatic Brain Injury
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 169
- Locations
- 1
- Primary Endpoint
- Diagnostic Accuracy of Cranial Point-of-Care Ultrasound
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Diagnostic Accuracy of Cranial Point-of-Care Ultrasound
Time Frame: 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.