跳至主要内容
临床试验/NCT05025150
NCT05025150招募中不适用

Point-of-Care Ultrasound for Pediatric Thoracic Trauma: A Multi-Institutional Trial

Sutter Health1 个研究点 分布在 1 个国家目标入组 1,020 人开始时间: 2019年8月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
Sutter Health
入组人数
1,020
试验地点
1
主要终点
Accuracy of POCUS as compared to chest X-ray in detecting injuries

研究概览

简要总结

The objective of the proposed study is to investigate the diagnostic accuracy of ED POCUS in pediatric traumatic thoracic injuries including traumatic pneumothorax, hemothorax, lung contusion, rib fractures, and pulmonary edema (from submersion injury). This will be a prospective, multicenter, observational study of children 0-21 years of age presenting to the participating pediatric emergency departments for suspected traumatic thoracic injury. Results of POCUS will be compared to that of chest X-ray, final clinical diagnosis, computed tomography (CT) or magnetic resonance imaging (MRI). Study hypotheses are that POCUS is highly accurate (90-95%) when compared to chest X-ray, and moderately accurate (~80%) when compared to CT or MRI in diagnosing these conditions.

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
0 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible subjects will be children 0 to 21 years of age presenting to the participating PEDs meeting trauma activation criteria and with suspected thoracic injury.

排除标准

  • Congenital or acquired cardiopulmonary or osteogenic conditions rendering POCUS ineffective, foreign body/ barrier to lung ultrasound of which removal is contraindicated, subjects under law-enforcement custody, and subjects deemed unsuitable by treating clinicians.

结局指标

主要结局

Accuracy of POCUS as compared to chest X-ray in detecting injuries

时间窗: 7-10 days

次要结局

  • Compare the accuracy of POCUS to chest X-ray or final clinical diagnosis (if no other imaging is performed).(7-10 days)
  • Compare the accuracy of POCUS to cross sectional imaging (CT or MRI).(7-10 days)

研究者

发起方
Sutter Health
申办方类型
Other
责任方
Principal Investigator
主要研究者

HIU FUNG SAMUEL LAM

Attending physician

Sutter Health

研究点 (1)

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