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临床试验/NCT04700384
NCT04700384已完成不适用

Comparing the Virtual Operative Assistant to Expert-based Instruction in Surgical Education: A Randomized Controlled Trial

McGill University1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
1
主要终点
Change in procedural performance .

研究概览

简要总结

Brief Summary:

Background:

Although surgical experience and technical skill are associated with better patient outcomes, quantitating surgical ability in the operating room is challenging. In surgical education, large datasets generated by high-fidelity virtual reality simulators can be employed by machine learning algorithms to objectively measure trainee performance and competence on expert benchmarks. This allows repetitive practice of surgical skills in safe and risk-free environments with immediate feedback.

Our group developed and has a patent pending for an intelligent tutoring system called the Virtual Operative Assistant (VOA). Utilizing an Artificial Intelligence (AI) support vector machine algorithm, the VOA assesses data derived from the NeuroVR (CAE Healthcare) simulator platform and provides individualized audiovisual feedback to improve learner performance during simulated brain tumor resections. The effectiveness of intelligent tutoring systems such as the VOA to the human surgical apprenticeship pedagogy remains to be elucidated.

The aim of this study is to compare the effectiveness and educational impact of personalized VOA feedback to expert instruction on medical student's technical skills learning of a virtual reality tumor resection procedure.

Specific Aims: 1) To assess if medical students receiving personalized VOA feedback statistically improve their surgical performance when compared to those having (a) no expert instructor feedback or (b) expert instructor-mediated feedback. 2) To outline if different emotions are elicited by the VOA intelligent tutoring system in medical students while performing this achievement task as compared to human instruction

详细描述

Design: A three-arm partially blinded randomized controlled trial of VOA training versus remote-based expert instruction versus control.

Setting: Neurosurgical Simulation and Artificial Intelligence Learning Centre, Montreal Neurological Institute.

Participants: Eligible first- and second-year medical students from across the province of Quebec.

Task: Complete removal of a simulated tumour - distinguishable by colour and haptic properties - with minimal bleeding and damage to surrounding healthy brain using two surgical instruments (Cavitron Ultrasonic Aspirator and Bipolar pincers) of the NeuroVR (CAE Healthcare) surgical simulator.

Intervention: A single 75-minute training session, including six virtual subpial tumour resection attempts (five simple practice scenarios and one complex realistic scenario) with assessment and feedback from either:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Participants will not know the purpose of trial

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •First- and second-year medical students from any Canadian institution who do not meet the

排除标准

  • •Exclusion Criteria: • Participation in any of our group's previous trials involving the NeuroVR (CAE Healthcare) simulator.

研究组 & 干预措施

Control Group

No Intervention

Control Group - Baseline Training

25 Participants allocated. Individuals receive introductory information on using the simulator and the scenario. They perform 5 simple subpial tumour resections for practice and have 5 minutes per trial. After each attempt, the student takes a 5-minute break with no assessment or feedback on their performance. On their 6th attempt they have 13 minutes to perform a different realistic scenario.

Experimental Group - Virtual Operative Assistance Training

Experimental

Experimental Group - Virtual Operative Assistance Training

25 participants allocated. Individuals receive the same information, have the same amount of time and perform the same scenarios as the control group. In the 5-minutes between attempts, participant receive the Virtual Operative Assistance Training assessment of their performance and audiovisual feedback.

干预措施: Virtual Operative Assistant Training (Behavioral)

Experimental Group - remote-based expert Instructor Training

Experimental

25 participants allocated. Individuals receive the same information, have the same amount of time and perform the same scenarios as the control group. Meanwhile, a trained instructor observes the participant's on-screen performance, that is live-streamed, remotely. Instructors are senior neurosurgery residents with extensive experience in performing and assessing this scenario. During the 5-minute feedback session, they chat with the student, discussing the performance and help in setting goals for the next trial.

干预措施: Remote-Based Expert Instructor Training (Behavioral)

结局指标

主要结局

Change in procedural performance .

时间窗: Day of Study

Performance in each practice attempt is measured utilizing raw data from the simulator that is used for assessment by previously established AI algorithms on validated metrics.

Change in learning

时间窗: Day of Study

Performance on the complex realistic scenario is evaluated by expert instructors using the Objective Structured Assessments of technical Skills (OSATS) Visual Rating Scale (weighted at 50%) and the AI assessment algorithms (weighted at 50%) creating a composite performance score.

次要结局

  • Difference in the strength of emotions elicited(Day of Study)
  • Difference in cognitive load(Day of Study)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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