AI Support in Novice's Decision-making for Ultrasound Fetal Weight Estimation
- Conditions
- Fetal WeightUltrasound
- Interventions
- Behavioral: Artificial Intelligence feedback for ultrasound EFW standard plane images
- Registration Number
- NCT06232187
- Lead Sponsor
- Copenhagen Academy for Medical Education and Simulation
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 75
- Medical students with no former fetal or abdominal ultrasound training.
- The participants will have to understand spoken and written Danish or English.
• 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Feedback Group 1 (FG1) Artificial Intelligence feedback for ultrasound EFW standard plane images Participatns in FG1 will receive basic black box AI support, with simple explanation like "standard plane", "non standard plane" or "off plane". Feedback Group 2 (FG2) Artificial Intelligence feedback for ultrasound EFW standard plane images Participants in FG2 will receive explainable AI support, with more elaborate description of the anatomical structures and segmentation of the anatomy.
- Primary Outcome Measures
Name Time Method Diagnostic accuracy 15 minutes The accuracy in each group was defined as the percentage difference between estimated fetal weight and the sonographer expert EFW
- Secondary Outcome Measures
Name Time Method Image Quality 5 minutes pr. participant Salomon criteria score is used to rate the image quality. Points are given depending on the number of landmarks present, quality of the image optimization and caliper.placements.
Minimum: 1 Maximum: 18. A higher score indicates a better image quality.
Trial Locations
- Locations (1)
Rigshospitalet
🇩🇰Copenhagen, Denmark