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临床试验/NCT04290247
NCT04290247已完成不适用

Non-inferiority of Ultrasound for the Diagnosis of Upper Extremity Fractures in Children

University Children's Hospital Basel2 个研究点 分布在 1 个国家目标入组 428 人开始时间: 2020年5月12日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
428
试验地点
2
主要终点
Sensitivity

研究概览

简要总结

This study evaluates the sensitivity of Ultrasound for Diagnostic of Fractures of the upper extremity compared to conventional x-ray in Children 0-18.

详细描述

Fractures of the upper extremity are common in children. Approximately 200 children with a suspected upper extremity fracture are treated every month in the paediatric emergency room (pER) of the University Hospital of Basel-Stadt and Basel-Land (UKBB).

If a fracture is suspected in the emergency room, two separate X-ray images have to be obtained to diagnose or exclude a fracture, according to the current standard operating procedure (SOP). This procedure has several disadvantages as X-ray imaging exposes children to radiation and transfer to the X-ray facility is time-consuming. Depending on the suspected fracture, the broken limb needs to be positioned for the two separate perspectives of the images, resulting in pain.

Furthermore, this procedure is time-consuming as the work routine of the attending emergency room physician is interrupted once the child is sent to the imaging facility and then returns to the emergency room after the procedure. The time between the request of the examination and interpretation of the results is called therapeutic turnaround time or brain-to-brain time.

X-ray images are interpreted by the pER paediatrician, and treatment is based upon this interpretation. A secondary reading by a paediatric radiologist for quality control is only done later on. This procedure has been adopted by several hospitals internationally.

X-ray interpretation by pER paediatricians has been evaluated by various studies, and the accuracy compared to paediatric radiologist interpretation is around 90% in most studies, with extremes ranging from 84% to 99%. In the past few years, ultrasound diagnosis of upper extremity fractures in adults and children has been studied. However, the evidence of its effectiveness is still limited, and its application in routine care is uncommon.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Patients presenting to the emergency room of the UKBB with a history of acute trauma to the upper extremities and suspected fracture of a long bone
  • Age 0-18 years

排除标准

  • Patient needing immediate medical attention (triage score 1 or 2)
  • Severely displaced or open fractures
  • Patient with neurovascular compromise distally to the suspected fracture.
  • Patient with imaging studies obtained prior to the emergency room visit
  • Patient with prior fracture of the affected area
  • Patient with known allergy to ultrasound gel.
  • Patient with suspected 'battered child' diagnosis.
  • Unavailability of a study investigator able to perform the ultrasound examination within a reasonable time frame (15 min; see also 3.2).

结局指标

主要结局

Sensitivity

时间窗: 1 year

Sensitivity of Ultrasound diagnostic compared to X-ray

次要结局

  • Pain level(1 year)
  • Time(1 year)
  • Displacement(2 years)

研究者

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

David Troxler

Principal Investigator

University Children's Hospital Basel

研究点 (2)

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