About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Medical students, neurosurgical residents, neurosurgical fellows, and staff neurosurgeons from one of four Quebec institutions who do not fit the
Disqualifiers
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.
Trial population
Staff neurosurgeons, neurosurgical fellows, neurosurgical residents, and medical students from four Quebec institutions.
Trial design
Case-only
Cross-sectional
Treatments tested in this trial
Observational
BehavioralAs such, no interventions are provided. All participants will perform three subpial resections on an ex vivo calf brain.
Treatment groups
Trial outcomes
Primary outcomes
Forces applied to the brain during each simulated subpial resection procedure
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. This will enable for the assessment of differences in force applied by novice, intermediate, and expert participants.
Secondary outcomes
Face validity questionnaire responses
Expert participants will fill out face validity questionnaires on 7-point Likert scales after the trial to assess the realism of the simulation platform, with 1 indicating lowest realism and 7 indicating highest realism.
Content validity questionnaire responses
Expert participants will fill out content validity questionnaires on 7-point Likert scales after the trial to assess the educational utility of the simulation platform, with 1 indicating lowest utility and 7 indicating highest utility.
Objective Structured Assessment of Technical Skills (OSATS) scores for each simulated subpial resection procedure
Blinded expert raters will review videos of each procedure and grade them using a modified OSATS rating scale on 7-point Likert scales, with 1 indicating worse performance and 7 indicating better performance. This will allow for the assessment of differences in performance between each expertise group, providing evidence of the platform's construct and convergent validity.
Strength of emotions elicited
Measured using the Medical Emotions Scale (MES) before the trial and after each of three simulated subpial resections. Participants self-reported emotional states via questionnaires on 7-point Likert scales, with 1 indicating lowest intensity and 7 indicating highest intensity.
Sponsors and contacts
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