Validation of an Ex Vivo Calf Brain Force Detection System for Neurosurgical Simulation Training: A Case Series Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
Neurosurgery is a high-stakes surgical specialty where errors can result in significant patient mortality and morbidity. The amount of force applied on the brain simultaneously by the multiple different instruments during complex neurosurgical procedures is a critical safety metric that, to the investigators' knowledge, has not been previously measured in a realistic operative environment.
The investigators have therefore developed a simulation platform integrating an ex vivo calf brain and a 3D-printed skull model attached to a force sensor capable of capturing real-time forces applied to the brain. A cross-sectional case series study will be conducted to evaluate the validity of the system. Medical students, neurosurgical residents, neurosurgical fellows, and staff neurosurgeons from four Quebec institutions will be recruited to perform three simulated subpial resections each using our ex vivo calf brain simulation platform. The forces applied by the microscissors, bipolar forceps, and ultrasonic aspirator onto the brain will be captured along with kinematic data. This study aims to establish the face, content, construct, and convergent validity of this ex vivo calf brain force detection system.
详细描述
Background and Rationale: The subpial resection technique is a complex neurosurgical procedure that is essential for brain tumor and epilepsy surgery. However, opportunities for trainees to gain hands-on experience with this procedure without risk to patient safety are limited. The force applied on the brain during tool-tissue contact is a critical factor impacting patient safety. While virtual simulation platforms enable force monitoring, ex vivo animal brains cannot readily capture quantitative data. The investigators have therefore developed a prototype of a simulation platform that integrates a force sensor and a calf brain and can accurately detect real-time forces during simulated subpial resections. This study seeks to investigate the validity of this ex vivo calf brain force detection system.
Hypotheses:
- The forces applied by instruments on an ex vivo calf brain during simulated subpial resection procedures will significantly differ between novice, intermediate, and expert participants.
- The ex vivo calf brain force detection system will demonstrate face, content, construct, and convergent validity.
- Levels of negative emotions, stress, and cognitive load will be greater in surgical trainees compared with experts.
Primary Objective: To measure and compare the forces applied by novice, intermediate, and expert participants during simulated ex vivo subpial resection procedures.
Secondary Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medical students, neurosurgical residents, neurosurgical fellows, and staff neurosurgeons from one of four Quebec institutions who do not fit the
排除标准
- •Exclusion Criteria:
- •For medical students, participation in a previous trial where they received training on the NeuroVR surgical simulator or the ex vivo calf brain simulation model.
研究者
Rolando Del Maestro
Director, Neurosurgical Simulation and Artificial Intelligence Learning Centre
McGill University