Clinical Trials Logo

Clinical Trial Summary

At the Neurosurgical Simulation and Artificial Intelligence Learning Centre, we seek to provide surgical trainees with innovative technologies that allow them to improve their surgical technical skills in risk-free environments, potentially improving patient operative outcomes. The Intelligent Continuous Expertise Monitoring System (ICEMS), a deep learning application that assesses and trains neurosurgical technical skill and provides continuous intraoperative feedback, is one such technology that may improve surgical education. In this randomized controlled trial, medical students from four Quebec universities will be blinded and randomized to one of three groups (one control and two experimental). Group 1 (control) will be provided with verbal AI tutor feedback based on the ICEMS error detection. Group 2 will be tutored by a human instructor who will receive ICEMS error data and deliver verbal instruction identical to that which the AI tutor delivers. Group 3 will be tutored by a human instructor who will be provided with ICEMS data but may deliver feedback as they feel is appropriate to correct the error. The aim of this study is to determine how the method of delivery of verbal surgical error instruction influences trainee response to instruction and overall surgical performance. Evaluating trainee responses to AI instructor verbal feedback as compared to feedback from human instructors will allow for further development, testing, and optimization of the ICEMS and other AI tutoring systems.


Clinical Trial Description

Background: Expert surgical technical skill is linked with improved patient outcomes; however, training novices to master these skills remains challenging. The Intelligent Continuous Expertise Monitoring System (ICEMS) is a deep learning application that was developed at the Neurosurgical Simulation and Artificial Intelligence Learning Centre to improve neurosurgical education. The ICEMS assesses and trains bimanual surgical performance by providing continuous feedback via verbal instructions in order to improve trainee performance and mitigate errors. Rationale: A previous randomized controlled trial (RCT) performed at our centre demonstrated that intelligent tutoring is more effective than expert tutoring in a simulated neurosurgical procedure (NCT05168150). Another RCT revealed that medical students' performance in response to ICEMS instruction to decrease bipolar force application was variable (NCT04700384). An agglomerative clustering algorithm classified these variable student responses into 3 groups: 53% successfully obeyed the instruction to correct the error, 36% did not obey the instruction, and 11% over-responded to the instruction. This response variability could significantly limit the utility of the ICEMS and may be attributed to different learning styles, stress levels, or misinterpretation of AI instruction. During this study, expert trainers were not provided with ICEMS error data. Conducting a new RCT in which expert trainers are provided with ICEMS error data will clarify the reason many trainees did not respond to the AI instruction. This report follows the Consolidated Standards of Reporting Trials-Artificial Intelligence (CONSORT-AI) as well as the Machine Learning to Assess Surgical Expertise (MLASE) checklist. Hypotheses: 1. Verbal AI feedback will yield significantly lower success response rates among trainees than identical error feedback provided by human instructors. 2. Trainee performance assessment scores will be significantly higher in the two different human instruction groups assessed. 3. Instruction delivered by the AI tutor will result in increased stress levels and cognitive load as compared to verbal error feedback delivered by human instructors. Primary Objectives: To determine how the method of delivery of surgical error instruction influences: 1. Trainee response to instruction, i.e., whether they corrected, did not correct, or over-corrected the error (data collected by the ICEMS). 2. Trainee overall surgical performance (average expertise score on practice scenarios calculated by the ICEMS, Objective Structured Assessment of Technical Skills (OSATS) score on realistic scenario determined by two blinded expert raters). Secondary Objective: To determine how the method of delivery of surgical error instruction influences trainee affective cognitive responses (self-reported via questionnaires on 5-point Likert scales). Setting: McGill University's Neurosurgical Simulation and Artificial Intelligence Learning Centre. Participants: Students enrolled in their preparatory, first, or second year at one of four Quebec medical schools. Design: A three-arm randomized controlled trial. Intervention: Participants will undergo a training session of approximately 90 minutes on the NeuroVR (CAE Healthcare), a virtual reality (VR) surgical simulator that simulates a subpial brain tumor resection. The NeuroVR has two possible scenarios: a simple practice scenario and a complex realistic scenario. Participants will perform six repetitions of the practice scenario (5 minutes each) followed by the realistic scenario (13 minutes). The ICEMS will continuously assess performance throughout the trial. All participants will receive verbal feedback when the ICEMS detects an error in their performance; however, the method of delivery of this verbal feedback will differ between groups. - Group 1 (control) will receive verbal feedback directly from the ICEMS when an error is detected. - Group 2 (experimental) will receive verbal feedback from an expert instructor delivered in the same words as the ICEMS. - Group 3 (experimental) will receive verbal feedback from an expert instructor delivered in their own words. Verbal feedback will be based on the following six metrics: 1. Tissue injury risk: When a trainee receives feedback on this metric, the healthy brain tissue has been damaged. 2. Bleeding risk: When a trainee receives feedback on this metric, there is bleeding that must be cauterized. 3. Instrument tip separation distance: Refers to the distance between the tip of the ultrasonic aspirator and the tips of the bipolar forceps. When a trainee receives feedback on this metric, their instruments are too far apart. 4. High bipolar force: Refers to the amount of force applied to the tissue by the bipolar forceps. When a trainee receives feedback on this metric, they are applying too much force with the bipolar. 5. Low bipolar force: Refers to the amount of force applied to the tissue by the bipolar forceps. When a trainee receives feedback on this metric, they are not applying enough force with the bipolar. 6. High aspirator force: Refers to the amount of force applied to the tissue by the ultrasonic aspirator. When a trainee receives feedback on this metric, they are applying too much force with the aspirator. These metrics will continuously be evaluated by the ICEMS. The ICEMS will only detect an error on one metric at a time according to a predetermined hierarchy (in the order listed above). For example, if a trainee makes an error on both bleeding risk (2) and high aspirator force (6) at the same time, the ICEMS will only detect an error for bleeding risk since this metric is above high aspirator force in the hierarchy. The first practice scenario will serve as a baseline; thus, no feedback will be given. In the second, third, fourth, and fifth repetitions, feedback will be given according to ICEMS error detection. In the sixth repetition as well as the realistic scenario, no feedback will be provided. Significance: With surgical education approaches beginning to shift towards competency-based frameworks, the implementation of effective AI educational feedback into surgical training becomes crucial for optimizing surgical learning. The results of this RCT will allow for the evaluation and reengineering of the ICEMS and other AI tutoring systems, which may advance the development of not only standardized competency-based surgical education training curricula, but any AI tutor technology dependent on verbal instruction. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06273579
Study type Interventional
Source McGill University
Contact Rolando F Del Maestro, MD, PhD
Phone (519) 708-0346
Email rolando.del_maestro@mcgill.ca
Status Not yet recruiting
Phase N/A
Start date March 2024
Completion date December 2024

See also
  Status Clinical Trial Phase
Completed NCT04691206 - Operative Curriculum Gallbladder Surgery N/A
Not yet recruiting NCT06421584 - Evaluating the Role of SURGical TElementoring in Acquisition of Surgical Skills of Laparoscopic Cholecystectomy. SURGTEACH Trial N/A
Not yet recruiting NCT05830786 - Virtual Reality in Orthopaedic Surgical Education: A Randomized Controlled Trial N/A
Not yet recruiting NCT04425499 - A Gamified Network for Surgical Education During COVID-19: A Randomized Controlled Trial N/A
Completed NCT04111679 - EffectS of prEferred Music on Laparoscopic performancE N/A
Completed NCT04908072 - Global Learning: an Orbis Virtual-platform Evaluation Study N/A
Completed NCT01560494 - Validation of a Curriculum (STAC) for Technical Skill Acquisition in Minimally Invasive Surgery N/A
Completed NCT05168150 - Testing the Efficacy of an Artificial Intelligence Real-Time Coaching SystemSystemSimulatioTraining of Medical Students N/A
Recruiting NCT06235788 - Effect of Intelligent Tutor Induced Pausing on Learning Simulated Surgical Skills N/A
Completed NCT04700384 - Effectiveness of an Artificial Intelligent Tutoring System in Simulation Training N/A
Withdrawn NCT04851665 - Intelligent Cooperation is Influenced by Learning Theories
Terminated NCT02986217 - The Effect of Structured Feedback on Live Surgical Performance N/A
Completed NCT04703400 - Analysis of the Impact on Surgical Residency Programs in Times of Pandemic in Argentina