Scan-AId: Artificial Intelligence Support in Novice's Decision-making for Assessing Ultrasound Fetal Weight Estimation - A Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy
研究概览
简要总结
The SCAN-AID study is a prospective, randomized, controlled, and unblinded study that compares the performance of novices in ultrasound fetal weight estimation. The study evaluates the impact of two levels of AI support: a straightforward black box AI and a more detailed explainable AI.
详细描述
The goal of this randomized controlled clinical trial is to learn which type of artificial intelligence (AI) effects the diagnostic accuracy of ultrasound estimation of fetal weight (EFW), when performed by novices, in this study represented by medical students.
The study's objectives are:
- Which type of artificial intelligence support system works for novices in improving the ultrasound fetal weight diagnostic accuracy?
- Does the artificial intelligence improve image quality, evaluate the cognitive load placed on participants when utilizing AI support, and is the AI system usable for novices?
Participants will be tasked with conducting an ultrasound Estimated Fetal Weight (EFW) using either a simple black box AI or a detailed explainable AI feedback system. The AI systems will assist participants in determining if they have captured the appropriate image for EFW. The outcomes will then be compared to those of a control group.
Ultrasound procedures will be performed on pregnant women with fetuses at a gestational age of 28-42 weeks, who have previously undergone an EFW by an expert sonographer or doctor at the clinic within 5 days days leading up to the examinationday. One participant of each randomization arm, will perfrom an EFW on the same pregnant woman.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
The ultrasound images will receive quality scoring from an experienced fetal medicin consultant. Theese are blinded for which intervention the participant received.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ultrasound novice participants:
- •Inclusion Criteria:
- •Medical students with no former fetal or abdominal ultrasound training.
- •The participants will have to understand spoken and written Danish or English.
排除标准
- •Medical students who received formal fetal or abdominal training prior to the inclusion in this study.
- •Pregnant women;
- •Inclusion Criteria:
- •The participants will have to understand spoken and written Danish or English.
- •BMI < 30
- •Gestational age: 28-42
- •Exclusion Criteria:
- •Age > 40 years
- •Fefal anomaly
- •Oligohydramnion
- •Gestational Diabetes, Diabetes type 1 or 2.
结局指标
主要结局
Diagnostic accuracy
时间窗: 15 minutes
The accuracy in each group was defined as the percentage difference between estimated fetal weight and the sonographer expert EFW
次要结局
- Image Quality(5 minutes pr. participant)
研究者
Mary Le Ngo
Doctor of medicine, PhD student
Copenhagen Academy for Medical Education and Simulation