Crossover Comparison of the Efficacy and Tolerance of Telerobotic vs Standard Ultrasound Exam in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Number of normal and abnormal standard and telerobotic ultrasound examinations
研究概览
简要总结
In children with Covid-19, the diagnosis of Kawasaki Disease (KD) and pneumonia should be made very quickly. However, the regional hospitals surrounding Paris don't have the required expertise. The use of MELODY allows the paediatric team to quickly carry out the necessary examinations while avoiding the movement of patients and the risk of contamination.
The MELODY remote system developed by the company AdEchoTech is a CE marking telemedicine technique, allowing an expert to perform an ultrasound scan on a distant patient (several hundred/thousands of kms). The Melody system makes it possible to optimize ultrasound expertise resources wherever they are located (all specialties combined) The feasibility of the clinical use of telerobotic sonography has been demonstrated in adults for abdominal, cardiac and prenatal exam. Thus, the aim of this study is to assess the feasibility of this system in children.
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
- 1 Year 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient from 1 year to 10 years
- •Patient requiring an ultrasound exam (thoracic, abdominal or cardiac)
- •French social security affiliation
排除标准
- •Obesity defined by a BMI greater than 30
- •Open wound making it impossible to carry out an ultrasound scan
- •Algetic patient
- •Instability of vital functions
- •Impossible to remain in a seated position
- •Refusal to participate in the study
研究组 & 干预措施
standard and telerobotic ultrasound
Included patients will have both ultrasound examination: standard ultraosound (abdominal, cardiac or pulmonary depending on the prescription and telerobotic ultrasound
干预措施: Ultrasound using the telerobotic Melody system (Device)
结局指标
主要结局
Number of normal and abnormal standard and telerobotic ultrasound examinations
时间窗: 1 day
Number of normal and abnormal examination conclusion for telerobotic and conventional ultrasound examinations
次要结局
- Number of anomalies found(Up to 4 hours)
- Parent satisfaction(Up to 4 hours)
- Sonographer satisfaction(Up to 4 hours)
- Age of participants(At baseline)
- Medical assistant satisfaction(Up to 4 hours)