Clinical Effectiveness of Contrast-Enhanced Ultrasound in the Evaluation of Blunt Abdominal Trauma in Young Children
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Sensitivity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age
研究概览
简要总结
The purpose of the study is to generate pilot data describing test characteristics of contrast enhanced ultrasound in young children with concern for abdominal trauma. The primary objective in this study is to determine the sensitivity and specificity of contrast-enhanced ultrasound (CEUS) compared to abdominal Computed Tomography (CT) in the detection of abdominal solid organ injury in young children < 8 years of age with concern for blunt abdominal trauma.
详细描述
Abdominal trauma in children can be deadly, but intra-abdominal injuries can be difficult to detect and often lack external signs of injury on physical exam. The current gold standard imaging study is Computed Tomography (CT) with IV contrast, which is associated with radiation exposure. Contrast-enhanced ultrasound is a radiation-free alternative to detect abdominal injuries and has been studied primarily in adults and some older children, but evidence to support its use in young children is needed.
This is a prospective study of children less than 8 years of age who are clinically stable and undergoing an abdominal CT with IV contrast as part of their clinical care due to concerns for abdominal trauma. Investigators will compare CEUS results with those obtained by CT. Investigators will additionally include retrospective data of children who underwent both abdominal CT and CEUS as part of clinical care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Contrast-Enhanced Ultrasound using Lumason
Prospective intervention using contrast enhanced ultrasound with IV contrast Lumason.
干预措施: Contrast-Enhanced Ultrasound using Lumason (Drug)
结局指标
主要结局
Sensitivity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age
时间窗: 2 years
To determine the sensitivity of contrast-enhanced ultrasound (CEUS) compared with standard, abdominal Computer Tomography (CT) in the detection of abdominal solid organ injury in young children \< 8 years of age with concern for blunt abdominal trauma.
Specificity of Contrast-Enhanced Ultrasound in detection of abdominal solid organ injury in young children <8 years of age
时间窗: 2 years
To determine the specificity of contrast-enhanced ultrasound (CEUS) compared with standard, abdominal Computer Tomography (CT) in the detection of abdominal solid organ injury in young children \< 8 years of age with concern for blunt abdominal trauma.
次要结局
未报告次要终点