RecruitingNot Applicable

Cranial Ultrasound for Point of Care Intracranial Pathology Detection in Pediatrics

United States169 participantsStarted 2024-11-24

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Diagnostic Accuracy of Cranial Point-of-Care Ultrasound

Timeframe: Day 1

Trial details

NCT IDNCT06697808

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-04

Contact for this trial

Denise Fraga, MD

704-355-3181 denise.fraga@atriumhealth.org

View on ClinicalTrials.gov More Traumatic Brain Injury trials