Clinical Medical Quality Control Management of Pediatric Intravenous Contrast-Enhanced Ultrasound(CEUS) in China: A Multi-Center Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- sensitivity
研究概览
简要总结
The goal of this clinical trial is to evaluate the application of intravenous contrast-enhanced ultrasound examination in children with intra-abdominal diseases that require clear diagnoses. The main questions it aims to answer are:
- Is intravenous contrast-enhanced ultrasound helpful for the diagnosis of intra-abdominal diseases in children?
- What medical problems do participants have when participating in intravenous contrast-enhanced ultrasound examination?
- How can ultrasound doctors conduct intravenous contrast-enhanced ultrasound examinations in a standardized manner? Researchers will performing intravenous contrast-enhanced ultrasound examinations on participants and collecting research subjects to establish a multicenter clinical data database.
Participants will:
- Perform abdominal ultrasound examination to assess the condition.
- At least conduct one intravenous contrast-enhanced ultrasound examination. Based on the result of the contrast examination, decide whether to conduct another examination.
- Keep a diary of their symptoms and therapeutic process in 30 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 29 Days 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 29 days to 18 years old;
- •The clinical diagnosis was abdominal space-occupying lesions, blunt abdominal trauma, ascites of unknown cause, and children with suspected abdominal disease but other examinations could not identify the cause.
排除标准
- •Allergic to sulfur hexafluoride or other components;
- •Heart disease with right-to-left shunt/severe pulmonary hypertension /uncontrolled systemic hypertension/respiratory failure/heart failure/severe arrhythmia;
- •Electrocardiogram, echocardiography or clinical manifestations of myocardial ischemia;
- •Patients with severe blood system diseases or infectious diseases;
- •Hypercoagulable state and recent history of thrombosis;
- •Severe hepatic and renal insufficiency;
- •Patients with respiratory tract infection or congenital respiratory malformation.
结局指标
主要结局
sensitivity
时间窗: Thirty days after the last venous ultrasound contrast examination
to calculate the sensitivity of venous contrast-enhanced ultrasound examination in children
specificity
时间窗: Thirty days after the last venous ultrasound contrast examination
to calculate the specificity of venous contrast-enhanced ultrasound examination in children
Positive predictive value
时间窗: Thirty days after the last venous ultrasound contrast examination
to calculate the positive predictive value of venous contrast-enhanced ultrasound examination in children
Negative predictive value
时间窗: Thirty days after the last venous ultrasound contrast examination
to calculate the negative predictive value of venous contrast-enhanced ultrasound examination in children
次要结局
未报告次要终点
研究者
Jingjing Ye
Director of the Ultrasound Department
The Children's Hospital of Zhejiang University School of Medicine