Non-inferiority of Ultrasound for the Diagnosis of Upper Extremity Fractures in Children
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
- 否
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
David Troxler
Principal Investigator
University Children's Hospital Basel
