AI Support in Novice's Decision-making for Ultrasound Fetal Weight Estimation

NCT06232187 | Enrolling By Invitation

• 1 other identifier: F-24001576
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Fetal Weight; Ultrasound

Keywords

Artificial Intelligence; Fetal weight estimation; novices

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy

  The accuracy in each group was defined as the percentage difference between estimated fetal weight and the sonographer expert EFW

  15 minutes

Secondary Outcomes (1)

• Image Quality

  5 minutes pr. participant

Other Outcomes (2)

• The AI system usability

  5 minutes

• Measurement of the reaction time

  5 minutes

Study Arms (3)

Feedback Group 1 (FG1)

EXPERIMENTAL

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

Behavioral: Artificial Intelligence feedback for ultrasound EFW standard plane images

Feedback Group 2 (FG2)

EXPERIMENTAL

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

Behavioral: Artificial Intelligence feedback for ultrasound EFW standard plane images

Control group (CG)

NO INTERVENTION

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

Interventions

Artificial Intelligence feedback for ultrasound EFW standard plane images BEHAVIORAL

AI feedback in two levels, in aid of the participants, to obtain the right standardplane images used in fetal ultrasound EFW calculation.

Feedback Group 1 (FG1); Feedback Group 2 (FG2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medical students with no former fetal or abdominal ultrasound training.
• The participants will have to understand spoken and written Danish or English.

You may not qualify if:

• Pregnant women;
• The participants will have to understand spoken and written Danish or English.
• BMI \< 30
• Gestational age: 28-42
• Age \> 40 years
• Fefal anomaly
• Oligohydramnion
• Gestational Diabetes, Diabetes type 1 or 2.

Sponsors & Collaborators

• Copenhagen Academy for Medical Education and Simulation: lead
• Slagelse Hospital: collaborator
• Technical University of Denmark: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Related Publications (16)

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MeSH Terms

Conditions

Fetal Weight

Condition Hierarchy (Ancestors)

Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The ultrasound images will receive quality scoring from an experienced fetal medicin consultant. Theese are blinded for which intervention the participant received.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of medicine, PhD student

Model Details: The participants are allocated to one of three groups: control group, feedback group 1 with black box AI or feedback group 2 with explainable AI feedback.

Study Record Dates

• First Submitted: January 22, 2024
• First Posted: January 30, 2024
• Study Start: February 14, 2024
• Primary Completion: June 30, 2024
• Study Completion: September 1, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)