Bedside Cranial Ultrasound for Risk-Stratified Imaging in Pediatric Acute Brain Injury

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-17
SponsorVirginia Commonwealth University

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

Open skull fracture

Prior hemicraniectomy

Cranial surgical defect at the insonation site

Anticipated transition to comfort-only care

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

220 Participants
are grouped into 1 trial group

Sponsors and collaborators

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