Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Traumatic Brain Injury. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics (CUPID-Peds)
Overview
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.
Primary outcome measures
- Diagnostic Accuracy of Cranial Point-of-Care Ultrasound [Time frame: Day 1]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Atrium Health Carolinas Medical Center — Charlotte
Identifiers
NCT: NCT06697808 · IRB00111568