AI Support in Novice's Decision-making for Ultrasound Fetal Weight Estimation (scan-AId)

Copenhagen Academy for Medical Education and Simulation

Status: Invitation-only

Conditions: Fetal Weight; Ultrasound

Treatments: Behavioral: Artificial Intelligence feedback for ultrasound EFW standard plane images

Study type: Interventional

Funder types: Other

Identifiers

NCT06232187

F-24001576

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Exclusion Criteria:

• 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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

Feedback Group 1 (FG1)

Experimental group

Description:

Participatns in FG1 will receive basic black box AI support, with simple explanation like "standard plane", "non standard plane" or "off plane".

Treatment:

Behavioral: Artificial Intelligence feedback for ultrasound EFW standard plane images

Feedback Group 2 (FG2)

Experimental group

Description:

Participants in FG2 will receive explainable AI support, with more elaborate description of the anatomical structures and segmentation of the anatomy.

Treatment:

Behavioral: Artificial Intelligence feedback for ultrasound EFW standard plane images

Control group (CG)

No Intervention group

Description:

Participants in the CG will have a standard plane poster to help guide them to the EFW ultrasound standard plane images.