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临床试验/NCT00652548
NCT00652548已完成不适用

Utility of Bedside Ultrasound to Diagnose Clavicle Fractures in the Pediatric Emergency Department

University of Louisville1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Comparison of a blinded reviewer's interpretation of bedside US images to an attending radiologist's interpretation of radiographs

研究概览

简要总结

This studies investigates the hypothesis that bedside ultrasound is as accurate as plain x-rays for diagnosing clavicle fractures in children in a pediatric emergency department. Children with shoulder injuries are enrolled and receive both an ultrasound imaging (experimental) and x-rays (standard-of-care) to see if ultrasound has the same (or better)accuracy, with less cost, time, and radiation.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
1 Year 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 1-18 years
  • Pain from recent shoulder/clavicle injury
  • Intact neurovascular exam
  • Radiographs performed as part of normal ED evaluation

排除标准

  • Hemodynamic instability
  • Multisystem trauma
  • Altered mental status
  • Open wounds to injured shoulder
  • Developmental delay
  • Prior radiographs at another clinic/hospital for this injury
  • Previous clavicle fracture on the affected side
  • Ultrasound gel allergy
  • Non-English-speaking parents/child (unable to give informed consent)

结局指标

主要结局

Comparison of a blinded reviewer's interpretation of bedside US images to an attending radiologist's interpretation of radiographs

时间窗: Single visit to emergency department

次要结局

  • Interoperator reliability between the blinded reviewer and bedside ED physician(Single ED visit)
  • FACES pain score for pain for US vs. radiographs for children ≥ 5 yrs(Single ED visit)
  • Unblinded real-time bedside US by the ED physician vs. radiographs(Single ED visit)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Keith Cross

Assistant Professor

University of Louisville

研究点 (1)

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