NCT01540318已完成不适用
Utility of Abdominal Ultrasound in the Evaluation of Children With Blunt Trauma
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 925
- 试验地点
- 2
- 主要终点
- Rate of Abdominal CT Scan
研究概览
简要总结
The major goal of this project is to conduct a randomized controlled trial studying an initial evaluation strategy with abdominal ultrasound versus a strategy without abdominal ultrasound for the evaluation of children with blunt abdominal trauma. The proposal's objectives are to compare the following variables in those that randomize to abdominal ultrasound versus those that do not:
- rate of abdominal CT scanning
- time to emergency department disposition
- the rate of missed/delayed diagnosis of intra-abdominal injury
- the costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •Blunt torso trauma resulting from a significant mechanism of injury
- •Motor vehicle collision: greater than 60 mph, ejection, or rollover
- •Automobile versus pedestrian/bicycle: automobile speed > 25 mph
- •Falls greater than 20 feet in height
- •Crush injury to the torso
- •Physical assault involving the abdomen
- •Decreased level of consciousness (Glasgow Coma Scale score < 15 or below age-appropriate behavior) in association with blunt torso trauma
- •Blunt traumatic event with any of the following (regardless of the mechanism):
- •Extremity paralysis
- •Multiple long bone fractures (e.g., tibia and humerus fracture)
- •History and physical examination suggestive of intra-abdominal injury following blunt torso trauma of any mechanism (including mechanisms of injury of less severity than mentioned above)
排除标准
- •No concern for inter-abdominal injury or no planned evaluation for possible IAI
- •Prehospital or ED age adjusted Hypotension
- •Prehospital or initial ED GCS score ≤ 8
- •Presence of an abdominal "seat belt sign" - continuous area of erythema/contusion completely across the lower abdomen secondary to a lap belt
- •Penetrating trauma: stab or gunshot wounds
- •Traumatic injury occurring > 24 hours prior to the time of presentation to the ED
- •Transfer of the patient to the UCDMC ED from an outside facility with abdominal CT scan, diagnostic peritoneal lavage, or laparotomy previously performed
- •Patients with known disease processes resulting in intraperitoneal fluid including liver failure and the presence of ventriculoperitoneal shunts
研究组 & 干预措施
No Abdominal Ultrasound
No Intervention
Abdominal Ultrasound
Experimental
Patients in the experimental arm will receive a "Focused Assessment with Sonography for Trauma (FAST)" which includes the use of abdominal ultrasound.
干预措施: Abdominal Ultrasound (FAST examination) (Procedure)
结局指标
主要结局
Rate of Abdominal CT Scan
时间窗: One week from enrollment
次要结局
- Total time spent in the Emergency Department(24 hours from enrollment)
- Cost effectiveness(two months from enrollment)
研究者
研究点 (2)
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