AI-Assisted Ultrasound-Guided Nerve Block: Model Development and Performance Assessment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- The accuracy of identifying the target anatomical structures in the annotated images.
研究概览
简要总结
This study intends to have experts with over 10 years of experience in ultrasound-guided regional anesthesia acquire 1,000 target images. These images will be annotated by both an AI model and human experts, and the model's annotations will be evaluated by a panel of 10 specialists. The primary outcome is the accuracy of identifying the target anatomical structures in the annotated images. Secondary outcomes include the number of true positive, false positive, true negative, and false negative structures, the time required for annotation, and the potential application of the AI model in assisting the performance of ultrasound-guided regional blocks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-70 years
- •BMI between 19-23 kg·m-²
- •ASA physical status classification I-II
- •Normal orientation and able to cooperate with physical examination.
排除标准
- •Patient refusal
- •Infection, trauma, skin defect, deformity, or other abnormalities at the intended nerve block site
- •Pregnancy
研究组 & 干预措施
AI Annotation
干预措施: AI Annotation (Device)
Manual Annotation
干预措施: manual annotation (Other)
结局指标
主要结局
The accuracy of identifying the target anatomical structures in the annotated images.
时间窗: From enrollment to the end of treatment at 4 months
次要结局
- The number of true positive (TP) structures(From enrollment to the end of treatment at 4 months)
- The number of false positive (FP) structures(From enrollment to the end of treatment at 4 months)
- The number of true negative (TN) structures(From enrollment to the end of treatment at 4 months)
- The number of false negative (FN) structures(From enrollment to the end of treatment at 4 months)
- The annotation time (time from the start to the end of annotation)(From enrollment to the end of treatment at 4 months)
- An evaluation of the AI model if applied to assist in performing ultrasound-guided regional blocks: a) its impact on block failure rate (increase, no effect, decrease); b) its impact on the incidence of adverse events (increase, no effect, decrease)(From enrollment to the end of treatment at 4 months)
研究者
Tao Xu
principal
Shanghai Jiao Tong University Affiliated Sixth People's Hospital