Measuring Force During Subpial Resection Procedure Using a Novel Ex Vivo Calf Brain Model With Integrated Sensor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Forces applied to the brain during each simulated subpial resection procedure step
研究概览
简要总结
Neurosurgery is a high-stakes surgical specialty where errors can result in significant morbidity. The amount of force applied simultaneously on the brain with 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 case series study will be conducted to evaluate the pattern of force applied. Medical students, neurosurgical residents, and staff neurosurgeons from McGill University will be recruited to perform subpial resections 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. This study aims to demonstrate the spectrum of force applied during a neurosurgical procedure using an ex vivo calf brain model.
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 gauge the force spectrum using this ex vivo calf brain force detection system.
Hypothesis: The simulation platform will accurately measure forces applied by novice, intermediate, and expert participants with surgical instruments on an ex vivo calf brain during simulated subpial resection procedures.
Co-Primary Outcomes: To assess the individual and combined instrumental force applications during subpial resection procedures in an ex vivo calf brain model.
Secondary Outcome: To differentiate levels of expertise of trial participants.
Setting: Montreal Neurological Institute and Hospital, McGill University, Montreal, Quebec, Canada.
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
- •Right-handed medical students, neurosurgical residents, and staff neurosurgeons from McGill University
排除标准
- •Left-handed individuals
结局指标
主要结局
Forces applied to the brain during each simulated subpial resection procedure step
时间窗: 1 day of study
Throughout each simulated ex vivo subpial resection procedure, forces applied to the brain during tool-tissue contact will be measured by the force/torque sensor in grams and Newtons.
次要结局
未报告次要终点
研究者
Rolando Del Maestro
Director, Neurosurgical Simulation and Artificial Intelligence Learning Centre
McGill University