Contrast Enhanced Ultrasonography for Blunt Abdominal Trauma Imaging in Children
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 146
- 试验地点
- 2
- 主要终点
- Sensitivity of CEUS
研究概览
简要总结
Children with blunt abdominal trauma often get a CT as the first line imaging to evaluate for intra-abdominal organ injury. CT scans have some downsides with regard to radiation exposure, costs, and need for transport. Contrast enhanced ultrasonography has recently shown some promise as a way to detect intra-abdominal organ injury and may be able to replace the need for conventional CT scanning, without the need for ionizing radiation and the ability to be performed at the bedside.
详细描述
In children with abdominal trauma, computed tomography (CT) of the abdomen is considered the gold standard for the initial evaluation of solid organ injuries. The major drawbacks to CT include risks due to radiation exposure and necessity of transport of the patient. Ultrasound without contrast uses safer non-ionizing radiation and can be performed at the bedside, however it has been shown to have variable sensitivity and specificity for identifying intra-abdominal organ injury. Newer studies using contrast enhanced ultrasound (CEUS) have shown promise for improving the sensitivity and specificity of this imaging modality.
Hypothesis(es) and Aims:
Hypothesis: Contrast enhanced ultrasound (CEUS) has good sensitivity and specificity as compared to a gold standard conventional CT scan for the identification of intra-abdominal solid organ injury in hemodynamically stable children with blunt abdominal trauma. Specific Aims:
Primary Aim: To determine the test characteristics CEUS / conventional ultrasound for the detection of intra-abdominal solid organ injury, as compared to a gold standard CT scan, in hemodynamically stable children with blunt abdominal trauma
Design:
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
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hemodynamically stable (defined as not needing massive transfusion protocol and not undergoing an emergent surgical procedure within the next hour)
- •History of or suspicion for blunt abdominal trauma
- •Abdominal CT ordered or obtained
排除标准
- •History of allergic reaction to Lumason, sulfur hexaflouride, sulfur hexafluoride lipid microsphere components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid)
- •Co-existing penetrating abdominal trauma
- •Known congenital or acquired heart disease
研究组 & 干预措施
Contrast-enhanced ultrasound arm
contrast-enhanced ultrasound
干预措施: Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON] (Drug)
Contrast-enhanced ultrasound arm
contrast-enhanced ultrasound
干预措施: contrast-enhanced ultrasound (Device)
结局指标
主要结局
Sensitivity of CEUS
时间窗: through study completion, which is expected to take around 3 years
calculation of sensitivity of CEUS for organ injury, as compared to gold standard CT
Specificity of CEUS
时间窗: through study completion, which is expected to take around 3 years
calculation of specificity of CEUS for organ injury, as compared to gold standard CT exam
次要结局
未报告次要终点
研究者
Aaron E. Chen
Professor of Clinical Pediatrics
Children's Hospital of Philadelphia