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

April 4, 2024 updated by: Mary Le Ngo, Copenhagen Academy for Medical Education and Simulation

Scan-AId: Artificial Intelligence Support in Novice's Decision-making for Assessing Ultrasound Fetal Weight Estimation - A Randomized Trial

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 30-37 weeks, who have previously undergone an EFW by an expert sonographer at the clinic either on the same day or the day before. One participant of each randomization arm, will perfrom an EFW on the same pregnant woman.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Feedback Group 1 (FG1)
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
AI feedback in two levels, in aid of the participants, to obtain the right standardplane images used in fetal ultrasound EFW calculation.
Experimental: Feedback Group 2 (FG2)
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
AI feedback in two levels, in aid of the participants, to obtain the right standardplane images used in fetal ultrasound EFW calculation.
No Intervention: Control group (CG)
Participants in the CG will have a standard plane poster to help guide them to the EFW ultrasound standard plane images.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy
Time Frame: 15 minutes
The accuracy in each group was defined as the percentage difference between estimated fetal weight and the sonographer expert EFW
15 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image Quality
Time Frame: 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.
5 minutes pr. participant

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The AI system usability
Time Frame: 5 minutes

The participants will be asked to answer a questionnaire: System Usability Scale (SUS), which is used to evaluate the AI feedback system.

Min 1 Maximum 100. A higher score indicating better system usability.
5 minutes
Measurement of the reaction time
Time Frame: 5 minutes

Measurements of the participants reaction time will a measurement for the cognitive load.

The reaction time will be measured as a secondary task while the participants are performing the ultrasound scan.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen Academy for Medical Education and Simulation

Collaborators

Slagelse Hospital
Technical University of Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2024

Primary Completion (Estimated)

June 30, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

January 22, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F-24001576

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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