An interventional study of Artificial Intelligence feedback for ultrasound EFW standard plane images in Fetal Weight and Ultrasound, sponsored by Copenhagen Academy for Medical Education and Simulation. Enrolling by invitation at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by Copenhagen Academy for Medical Education and Simulation · Not applicable, Interventional, and Diagnostic
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.
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:
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.
17 studies on the registry are indexed under Fetal Weight; 7 are open to participants now.
Browse Fetal Weight studies →Copenhagen Academy for Medical Education and Simulation is the lead sponsor of 27 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Ultrasound novice participants:
Inclusion Criteria:
Exclusion Criteria:
Pregnant women;
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Participants in the CG will have a standard plane poster to help guide them to the EFW ultrasound 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.
Diagnostic accuracy
The accuracy in each group was defined as the percentage difference between estimated fetal weight and the sonographer expert EFW
Time frame: 15 minutes
Image Quality
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.
Time frame: 5 minutes pr. participant
The AI system usability
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.
Time frame: 5 minutes
Measurement of the reaction time
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.
Time frame: 5 minutes
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Copenhagen Academy for Medical Education and Simulation