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Surgical EducationNCT06273579

Effect of Artificial Intelligence-Augmented Human Instruction on Surgical Simulation Performance

A study testing Expert instruction using AI tutor script and AI-augmented personalized expert instruction in people with Surgical Education, run by McGill University at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Surgical Education
What is being tested?
Expert instruction using AI tutor script and AI-augmented personalized expert instruction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteCanada
Study dates
9 Mar 2024to 14 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Medical students who are actively enrolled in their preparatory, first, second year of medical school at any Quebec institution who do not fit the exclusion criteria.

Who cannot join

  • Prior use of the NeuroVR (CAE Healthcare) simulator.

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Neurosurgical Simulation and Artificial Intelligence Learning Centre

    Montreal, Quebec, H2X 4B3

Other trials in Canada

About this study

Official title: Effect of Artificial Intelligence-Augmented Human Instruction on Surgical Simulation Performance: A Randomized Controlled Trial

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 using the same words as the ICEMS. Group 3 will be tutored by a human instructor who will be provided with ICEMS data and will then deliver personalized feedback.

The aim of this study is to determine how the method of delivery of verbal surgical error instruction influences trainee technical skill acquisition and transfer. 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.

Read the detailed 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). However, during this study, expert instructors were not provided with ICEMS error data. Conducting a new RCT in which expert instructors are provided with quantitative ICEMS error data will allow us to determine the most effective method for teaching surgical technical skills to trainees in virtual operative procedures.

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. AI-augmented personalized expert instruction will be more effective at improving technical skill acquisition and skill transfer in trainees compared to AI tutor instruction.
  2. Instruction delivered by human instructors will result in lower levels of negative emotions and cognitive load compared with instruction delivered by the AI tutor.

Primary Objectives: To determine how the method of delivery of surgical error instruction influences:

  1. Trainee technical skill acquisition and overall surgical performance (composite expertise scores across all practice tasks calculated by the ICEMS).
  2. Trainee skill transfer to a more complex realistic scenario (composite expertise scores during realistic task calculated by the ICEMS).

Secondary Objective: To determine how the method of delivery of surgical error instruction influences trainee affective-cognitive responses, including emotions-self-reported via questionnaires administered before, during, and after learning using the Medical Emotions Scale (MES) on 7-point Likert scales-and cognitive load-self-reported via questionnaire administered after learning using the Cognitive Load Index (CLI) 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. In this study, participants will perform two different scenarios on the NeuroVR: 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 real-time verbal feedback directly from the ICEMS when an error is detected.
  • Group 2 (experimental) will receive real-time verbal feedback from an expert instructor delivered in the same words as the ICEMS.
  • Group 3 (experimental) will receive real-time, personalized 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 or is at risk of being damaged.
  2. Bleeding risk: When a trainee receives feedback on this metric, there is bleeding that must be cauterized or a risk of bleeding.
  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 provide feedback on one metric at a time according to a predetermined hierarchy (in the order listed above). For example, if the ICEMS detects on error on both bleeding risk (2) and high aspirator force (6) at the same time, the system will only provide feedback on bleeding risk since this metric is above high aspirator force in the hierarchy.

One of neurosurgical residents who will instruct participants is completing an MSc at the Neurosurgical Simulation and Artificial Intelligence Learning Centre and the other two are conducting simulation research at our center. All three have had extensive experience performing subpial resection procedures using the NeuroVR simulator and our ex vivo calf brain model, as well as in the operating room. As such, these individuals are considered competent experts for the purpose of this simulation trial. Prior to the start of the trial, pilot studies were conducted. Each resident instructed three to five participants during these pilot studies. They were each evaluated by a senior consultant neurosurgeon with decades of clinical experience with subpial resections and subsequently identified as experts for their ability to instruct novice participants.

Study Procedure: Prior to the simulation session, the study coordinator will stratify participants according to their year in medical school and block randomize them to one of three intervention arms with an allocation ratio of 1:1:1 using random number sequences generated by Random.org. Upon arrival, participants will read and sign an informed consent form. They will then fill out a pre-trial questionnaire recording demographic information and self-reported baseline emotions using the MES. Trial instructions introducing the NeuroVR simulator, the instruments, and the practice subpial resection scenario will be provided via a written document followed by a video. Each practice task will last 5 minutes, followed by a 5-minute rest period. No post-hoc feedback will be provided during the rest periods. Participants will perform their first practice task without feedback to establish a baseline. Participants will then perform their second through fifth practice tasks while receiving their assigned educational intervention. This metric-specific action-oriented feedback will be provided according to ICEMS error detection. The sixth repetition of the practice task will serve as a summative assessment wherein participants will receive no feedback. Following the completion of the practice tasks, participants will complete a peri-trial questionnaire to assess their emotions using the MES. They will be provided with another information document introducing the realistic subpial brain tumor resection task. Participants will complete the 13-minute realistic task to assess their skill transfer to a more complex scenario. Finally, they will fill out a post-trial questionnaire assessing their emotions using the MES and their cognitive load using the CLI.

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.

Being tested
Expert instruction using AI tutor script, AI-augmented personalized expert instruction
Keywords
Virtual Reality, Artificial Intelligence, Surgical Training, Surgical Education, Surgical Simulation, Neurosurgery

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Expert instruction using AI tutor scriptBehavioural

    Expert instructor assigned to tutor this group will receive error detection data from the ICEMS. They will also be provided with a list of commands that the ICEMS uses. When the system detects an error in a student's performance for a given metric, the instructor must deliver this command using the exact wording provided by the ICEMS.

  • AI-augmented personalized expert instructionBehavioural

    Expert instructor assigned to tutor this group will receive error detection data from the ICEMS. When the system detects an error in a student's performance for a given metric, the instructor will have the freedom to personalize and contextualize feedback without restriction to ICEMS wording.

Study groups in NCT06273579
Study groupRoleWhat they receive
AI tutor instruction groupNo intervention31 participants allocated. During their second, third, fourth, and fifth repetition of the practice subpial brain tumor resection scenario, participants will receive verbal ICEMS feedback when the system detects an error on their performance.
Expert instruction groupExperimental29 participants allocated. During their second, third, fourth, and fifth repetition of the practice subpial brain tumor resection scenario, participants will receive verbal feedback from an expert instructor. The expert instructor will deliver this feedback using the same words as the ICEMS.
Receives: Behavioral: Expert instruction using AI tutor script
Personalized expert instruction groupExperimental28 participants allocated. During their second, third, fourth, and fifth repetition of the practice subpial brain tumor resection scenario, participants will receive verbal feedback from an expert instructor. The expert instructor will use their expertise to deliver personalized feedback to the participant.
Receives: Behavioral: AI-augmented personalized expert instruction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intelligent Continuous Expertise Monitoring System (ICEMS) expertise score - Technical skill acquisition across practice tasks on NeuroVR simulator

    The ICEMS will continuously evaluate the trainee's performance during each practice task and calculate average expertise scores on a scale of -1.00 (novice) to 1.00 (expert). This will allow us to assess learner technical skill acquisition from the first through sixth repetitions of the practice task.

    Measured: 1 day of study

  2. Intelligent Continuous Expertise Monitoring System (ICEMS) expertise score - Technical skill transfer during complex realistic task on NeuroVR simulator

    The ICEMS will continuously evaluate the trainee's performance during the realistic task and calculate an average expertise score on a scale of -1.00 (novice) to 1.00 (expert). This will allow us to assess learner technical skill transfer from the practice tasks to a more complex realistic scenario.

    Measured: 1 day of study

Secondary outcomes (2)
  1. Strength of emotions elicited

    Measured using Duffy's Medical Emotions Scale (MES) before, during, and after the intervention (self-reported via questionnaires on 7-point Likert scales).

    Measured: 1 day of study

  2. Levels of cognitive load

    Measured using Leppink's Cognitive Load Index (CLI) after the intervention (self-reported via questionnaire on 5-point Likert scales).

    Measured: 1 day of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2024
  2. Study start9 Mar 2024
  3. Primary completion14 Sep 2024
  4. Study completion14 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized Controlled Trial
Masking
Single blind
Who is masked
Participant
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06273579
Sponsor's protocol ID
2010-270, NEU-09-042-Trial 5
Status last verified
May 2025
First submitted
7 Feb 2024
Last updated
30 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data obtained from primary and secondary outcomes may be shared if other researchers have an interest in this data.

Publications

  • Yilmaz R, Bakhaidar M, Alsayegh A, Abou Hamdan N, Fazlollahi AM, Tee T, Langleben I, Winkler-Schwartz A, Laroche D, Santaguida C, Del Maestro RF. Real-Time multifaceted artificial intelligence vs In-Person instruction in teaching surgical technical skills: a randomized controlled trial. Sci Rep. 2024 Jul 2;14(1):15130. doi: 10.1038/s41598-024-65716-8.

    PubMed 38956112
  • Fazlollahi AM, Bakhaidar M, Alsayegh A, Yilmaz R, Winkler-Schwartz A, Mirchi N, Langleben I, Ledwos N, Sabbagh AJ, Bajunaid K, Harley JM, Del Maestro RF. Effect of Artificial Intelligence Tutoring vs Expert Instruction on Learning Simulated Surgical Skills Among Medical Students: A Randomized Clinical Trial. JAMA Netw Open. 2022 Feb 1;5(2):e2149008. doi: 10.1001/jamanetworkopen.2021.49008.

    PubMed 35191972
  • Yilmaz R, Fazlollahi AM, Winkler-Schwartz A, Wang A, Makhani HH, Alsayegh A, Bakhaidar M, Tran DH, Santaguida C, Del Maestro RF. Effect of Feedback Modality on Simulated Surgical Skills Learning Using Automated Educational Systems- A Four-Arm Randomized Control Trial. J Surg Educ. 2024 Feb;81(2):275-287. doi: 10.1016/j.jsurg.2023.11.001. Epub 2023 Dec 29.

    PubMed 38160107
  • Fazlollahi AM, Yilmaz R, Winkler-Schwartz A, Mirchi N, Ledwos N, Bakhaidar M, Alsayegh A, Del Maestro RF. AI in Surgical Curriculum Design and Unintended Outcomes for Technical Competencies in Simulation Training. JAMA Netw Open. 2023 Sep 5;6(9):e2334658. doi: 10.1001/jamanetworkopen.2023.34658.

    PubMed 37725373
  • Mirchi N, Bissonnette V, Yilmaz R, Ledwos N, Winkler-Schwartz A, Del Maestro RF. The Virtual Operative Assistant: An explainable artificial intelligence tool for simulation-based training in surgery and medicine. PLoS One. 2020 Feb 27;15(2):e0229596. doi: 10.1371/journal.pone.0229596. eCollection 2020.

    PubMed 32106247
  • Winkler-Schwartz A, Yilmaz R, Mirchi N, Bissonnette V, Ledwos N, Siyar S, Azarnoush H, Karlik B, Del Maestro R. Machine Learning Identification of Surgical and Operative Factors Associated With Surgical Expertise in Virtual Reality Simulation. JAMA Netw Open. 2019 Aug 2;2(8):e198363. doi: 10.1001/jamanetworkopen.2019.8363.

    PubMed 31373651
  • Davidovic V, Giglio B, Albeloushi A, Alhaj AK, Alhantoobi M, Saeedi R, Deraiche S, Yilmaz R, Tee T, Fazlollahi AM, Ha M, Uthamacumaran A, Balasubramaniam N, Correa JA, Del Maestro RF. Effect of Artificial Intelligence-Augmented Human Instruction on Feedback Frequency and Surgical Performance During Simulation Training. J Surg Educ. 2025 Nov;82(11):103743. doi: 10.1016/j.jsurg.2025.103743. Epub 2025 Oct 8.

    PubMed 41066879
  • Giglio B, Albeloushi A, Alhaj AK, Alhantoobi M, Saeedi R, Davidovic V, Uthamacumaran A, Yilmaz R, Lapointe J, Balasubramaniam N, Tee T, Fazlollahi AM, Correa JA, Del Maestro RF. Artificial Intelligence-Augmented Human Instruction and Surgical Simulation Performance: A Randomized Clinical Trial. JAMA Surg. 2025 Sep 1;160(9):993-1003. doi: 10.1001/jamasurg.2025.2564.

    PubMed 40768205

Questions about this trial

What is this clinical trial studying?

A study testing Expert instruction using AI tutor script and AI-augmented personalized expert instruction in people with Surgical Education, run by McGill University at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intelligent Continuous Expertise Monitoring System (ICEMS) expertise score - Technical skill acquisition across practice tasks on NeuroVR simulator (time frame: 1 day of study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06273579, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2025.

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