Rigshospitalet
Copenhagen, København Ø, 2100, Denmark
NCT Number: NCT07476638
Objective: To evaluate the impact of real-time AI feedback on fetal biometry accuracy and investigate the Expertise Reversal Effect-whether AI benefits diminish as user experience increases.
Design: A stratified randomized trial of 75 participants (25 Novices, 25 Intermediates, 25 Experts). Users are randomized 1:1 to either AI-assisted or manual measurement groups.
Outcomes:
* Primary: EFW accuracy (MAPE) compared to actual birthweight. * Secondary: Procedure time, image quality, error relative to baseline scans, and cognitive workload (NASA-TLX).
Trial opening soon.
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Interventional
Not applicable
Copenhagen, København Ø, 2100, Denmark
Study Overview: This study evaluates how real-time Artificial Intelligence (AI) feedback impacts the accuracy of fetal biometry measurements in obstetric ultrasound. While AI tools are designed to assist clinicians, their effectiveness may vary depending on the user's baseline skill level-a phenomenon known as the "Expertise Reversal Effect."
Research Aim: The primary objective is to determine if AI-guided feedback significantly reduces measurement error in ultrasound fetal weight estimation to traditional manual methods. The study specifically investigates whether the benefit of AI is greater for novice users, intermediate users users than for experienced specialists.
Study Design: This is a stratified, randomized controlled trial involving 75 participants categorized into three expertise tiers:
Novices (e.g., students or residents with minimal scan experience).
Intermediate Users (e.g., physicians in mid-level training).
Experts (e.g., senior specialists).
Participants within each tier will be randomized 1:1 to either the AI-Assisted Group (receiving real-time automated plane validation and calipers) or the Control Group (performing standard manual biometry).
Primary Outcome Measure: Accuracy of Estimated Fetal Weight (EFW): The Mean Absolute Percentage Error (MAPE) of the EFW relative to the actual birthweight, assessing the clinical impact of AI assistance on weight prediction.
Secondary Outcome Measures:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Clinical Target Population: Healthcare professionals and students, including but not limited to:
Exclusion:
Pregnant women:
Inclusion criteria
Exclusion criteria
Participants in the intervention arm perform fetal biometry with the assistance of real-time Artificial Intelligence (AI) feedback software.
Time frame: The two scans will be performed within a timeframe of 14 days.
Mean absolute percentage error (MAPE), defined as the absolute difference between estimated fetal weight (EFW) and actual birth weight (ABW) divided by actual birth weight and expressed as a percentage, for AI-assisted and manual fetal biometry.
Time frame: The duration of the scan, maximum of 30 minutes
Scan duration (seconds) will be modeled as the dependent variable to assess the tem-poral impact of the AI-feedback.
Time frame: Through study completion, an average of 1 year.
Salomon Quality Score on the 16-point fetal biometry plane quality scale, comparing AI-assisted and manual ultrasound acquisition. The scale ranges from 0 to 16, with higher scores indicating better anatomical plane quality.
Time frame: During the ultrasound procedure (GSR) and immediately following the procedure (NASA-TLX), approximately 30 minutes in total.
Both the NASA-TLX (subjective) and GSR (objective) data will be modeled as de-pendent variables. These analyses will determine if the AI-intervention significantly alters the mental effort or autonomic stress response during the procedure.
Time frame: The duration from pre study scan and study scan.
The absolute difference between the participant's EFW and a baseline EFW performed of an experienced clinician, will be modeled to assess if AI reduces inter-observer variability.
Time frame: Through study completion, an average of 1 year.
Estimated interaction effect between operator experience (continuous, experience level) and intervention (AI-assisted vs manual) on mean absolute percentage error (MAPE), and the corresponding experience level at which the adjusted difference in MAPE between groups is not statistically significant.
Contact information is provided by the study sponsor or research team.
Copenhagen Academy for Medical Education and Simulation
Other
Evaluating the Sensitivity to Change of AI-Feedback in Ultrasound Biometry: A Stratified Randomized Controlled Trial Across the Expertise Gradient
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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