Bedside Cranial Point-of-Care Ultrasound (cPOCUS) for Risk-Stratified Imaging in Pediatric Acute Brain Injury: A Prospective Diagnostic-Accuracy and Longitudinal Biomarker Cohort Study (CUPID-Peds)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of cranial point-of-care ultrasound (cPOCUS) versus head CT
研究概览
简要总结
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.
详细描述
Prospective observational cohort study of children undergoing clinically indicated head CT for suspected acute brain injury (ABI) in the pediatric ED and PICU at the Children's Hospital of Richmond at Virginia Commonwealth University (CHoR-VCU). Within 6 hours of the head CT, trained research scanners (acquisition-only role) acquire standardized B-mode cranial point-of-care ultrasound (cPOCUS) using 1-3 MHz phased-array probes through bilateral temporal and frontal windows, exporting de-identified 3-5 second cine loops at and around the midbrain plane to an encrypted offline reading workstation. Two pre-specified expert readers interpret the studies independently and offline in Horos, each blinded to the clinical course, the head-CT report, and one another; discordant cases are resolved by joint re-read to a single adjudicated consensus interpretation, which serves as the cPOCUS index test. The attending radiology head-CT report is the diagnostic gold (reference) standard. Because reads are not returned to the clinical team in real time, cPOCUS is not an assigned intervention, and the endpoints are diagnostic test characteristics, there is no change to clinical care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
- •Cranial ultrasound feasible within the protocol time window (within 6 hours of head CT)
排除标准
- •Open skull fracture
- •Prior hemicraniectomy
- •Cranial surgical defect at the insonation site
- •Anticipated transition to comfort-only care
- •Any clinical condition in which cranial ultrasound would delay a time-critical intervention
研究组 & 干预措施
Children undergoing clinically indicated head CT for suspected ABI in the pediatric ED and PICU
Combined ED + PICU sampling enriches for CT-positive cases and supplies the serial-imaging subset.
结局指标
主要结局
Diagnostic accuracy of cranial point-of-care ultrasound (cPOCUS) versus head CT
时间窗: First paired CT-cPOCUS assessment (cPOCUS within 6 hours of head CT; Day 1)
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.
次要结局
- Inter-reader reliability of cPOCUS interpretation(First paired assessment; monitored quarterly through study completion (up to 24 months))
- Per-reader diagnostic accuracy and paired reader comparison(First paired CT-cPOCUS assessment (Day 1))
- Etiology- and subgroup-specific diagnostic accuracy (descriptive)(First paired CT-cPOCUS assessment (Day 1))
- Age and skull-thickness inflection point (upper age limit of utility)(Through study completion (up to 24 months))
- Pediatric cPOCUS atlas feature and artifact agreement(Through study completion (up to 24 months))
- Longitudinal midline-shift agreement (cPOCUS vs CT)(Serial paired scans over ICU stay (up to 24 months))
- Longitudinal hydrocephalus and new parenchymal echogenicity agreement(Serial paired scans over ICU stay (up to 24 months))
- Evolving versus stable pathology (exploratory longitudinal model)(Serial paired scans over ICU stay (up to 24 months))