Acute brain injury (ABI) is a leading cause of death and long-term disability in children. Diagnosis depends on fast neuroimaging, and head computed tomography (CT) is the bedside reference standard despite exposing the developing brain to ionizing radiation. A safe, portable, radiation-free bedside tool is needed to help decide which children need a head CT, to speed CT when injury is present, and to safely monitor injured children between scans. This study evaluates B-mode cranial point-of-care ultrasound (cPOCUS) performed through the temporal (and frontal) bone windows in children undergoing a clinically indicated head CT in the pediatric emergency department (ED) and pediatric intensive care unit (PICU). Children's thin skulls provide adequate acoustic windows in more than 95% of cases. cPOCUS is acquired by trained research scanners within 6 hours of head CT and interpreted offline by two blinded expert readers; the radiology CT report is the diagnostic gold standard. This is a prospective observational study; cPOCUS results are not returned to the clinical team in real time and do not change clinical care.
Children 2 to 17 years of age
Undergoing a clinically indicated (standard-of-care) head CT for suspected acute brain injury (including trauma, headache with neurologic findings, altered mental status, focal deficit, seizure, post-cardiac-arrest, oncologic neurologic emergency, or intracranial infection)
Seen in the pediatric Emergency Department or Pediatric Intensive Care Unit at the Children's Hospital of Richmond at VCU (CHoR-VCU)
Consent obtainable from a legally authorized representative (LAR)
Open skull fracture
Prior hemicraniectomy
Cranial surgical defect at the insonation site
Anticipated transition to comfort-only care
Children undergoing a clinically indicated head CT for suspected acute brain injury in the pediatric Emergency Department and Pediatric Intensive Care Unit at the Children's Hospital of Richmond at VCU. Combined ED + PICU sampling enriches the cohort for CT-positive cases and provides the CT-positive subset with serial paired imaging.
Cohort
Prospective
Not listed
Diagnostic accuracy of cranial point-of-care ultrasound (cPOCUS) versus head CT
Diagnostic accuracy of the adjudicated consensus cPOCUS read (index test) for a binary abnormal versus normal head CT (reference standard = attending radiology CT report), reported as sensitivity, specificity, positive predictive value, and negative predictive value, each with 95% confidence intervals, at the first paired CT-cPOCUS assessment. Abnormal scan is defined as presence of any new midline shift, hydrocephalus or parenchymal echogenicity.
Inter-reader reliability of cPOCUS interpretation
Agreement between the two blinded expert readers on the binary cPOCUS classification of midline shift, hydrocephalus or parenchymal echogenicity, quantified by Cohen's kappa (prespecified threshold kappa \>= 0.8); observed agreement and Gwet's AC1 reported given anticipated low prevalence.
Per-reader diagnostic accuracy and paired reader comparison
Each reader's independent binary cPOCUS call scored against head CT for per-reader sensitivity and specificity for midline shift, hydrocephalus or parenchymal echogenicity ; the two readers compared on the same patients by the paired McNemar test.
Etiology- and subgroup-specific diagnostic accuracy (descriptive)
Descriptive, explicitly underpowered estimates of cPOCUS accuracy by prespecified subgroups: age band (2-5, 6-12, 13-17 years), acoustic-window adequacy, mechanism/clinical presentation, and underlying diagnosis; sex-stratified accuracy prespecified per NIH sex-as-a-biological-variable policy.
Age and skull-thickness inflection point (upper age limit of utility)
Identification of the age/skull-thickness threshold above which cranial ultrasound loses screening utility, from age-stratified accuracy and window-adequacy analysis.
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Virginia Commonwealth University
Lead sponsor
UMass Chan Medical School
Collaborator
Atrium Health Levine Children's Hospital
Collaborator
Children's Hospital of Richmond at VCU
Collaborator
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