Simulation Efficacy in Neurosurgical Education (SENSE)

Investigating the Efficacy of Simulation Curricula in Neurosurgical Education

This study aims to investigate the efficacy of simulation in neurosurgical training.

Study Overview

• Status: Unknown
• Conditions: Simulation; Intraventricular Hemorrhage; Hydrocephalus; Educational
• Intervention / Treatment: Other: Simulation training; Other: ''See one, do one'' approach

Detailed Description

This study aims to investigate the efficacy of simulation in neurosurgical training. This will be assessed using accuracy and speed tests in the placement of external ventricle drain catheters (EVDs). EVD placement is a relatively simple neurosurgical procedure aimed at inexperienced young trainees.

This study has two arms. The recruits are inexperienced trainees and/or interns and students who have never performed EVD placements before. The recruits are randomly assigned (using computer-based randomisation) to either Arm A or Arm B.

Recruits to Arm A undergo simulation training (computer simulation of the procedure, followed by simulation on a dead animal model), after which the recruits will attempt to perform an EVD procedure on their own, on a 3D-printed skull model that we designed.

Recruits to Arm B will witness an EVD placement as performed by an experienced surgeon, after the recruits will attempt to perform an EVD procedure on their own, using the aforementioned 3D-printed skull model. This mimics the ''see one, do one'' paradigm prevalent in surgical training.

The efficacy of the simulation training will be assessed using the following criteria:

i. Accuracy test:

The accuracy of the catheter placement is assessed in both arms and compared to investigate whether there is a difference in the accuracy of the catheter placement in both arms.

ii. Speed test:

The speed of catheter placement is assessed in both arms and compared to investigate whether there is a difference in the speed of the catheter placement in both arms.

iii. Subjective surveys

The researchers will gauge the extent of the trainees' confidence in their surgical skills and their satisfaction with their training before and after completion of the simulation training using a questionnaire to be designed for this purpose. The trainees will assess their own familiarity with and confidence in the procedure using a scale from 0 ("not familiar with the procedure", "I have no confidence in being able to perform this procedure independently") to 10 ("I am an expert at this procedure", "I am able to perform this procedure independently with complete confidence"). This data will be collected and input into a statistical software (Statistical Lab v. 3, CeDiS) to analyse the difference (if any) in the trainees' familiarity with the procedures and their confidence in being able to perform them in both arms.

• Study Type: Observational
• Enrollment (Anticipated): 20

Contacts and Locations

Study Locations

• Germany
  • Rheinland Pfalz
    • Mainz, Rheinland Pfalz, Germany, 55131
      • Recruiting
      • University of Mainz / Department of Neurosurgery
      • Contact: Amr Nimer Amr; Phone Number: 06131 177331; Email: amr@uni-mainz.de
      • Contact: Eleftherios Archavlis, MD; Phone Number: 06131 177331; Email: eleftherios.archavlis@unimedizin-mainz.de
      • Principal Investigator: Amr Nimer
      • Sub-Investigator: Eleftherios Archavlis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The recruits to the study are inexperienced surgical trainees and/or interns and students who have never performed EVD placements before.

Description

Inclusion Criteria:

• never performed EVD placements before

Exclusion Criteria:

• any surgical experience with EVD placement

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Arm A: Simulation training cohort; Recruits to Arm A undergo simulation training (computer simulation of the procedure, followed by simulation on a dead animal model), after which they will attempt to perform an EVD procedure on their own, on a 3D-printed skull model that we designed.	Other: Simulation training; Simulation training (computer simulation of the procedure, followed by simulation on a dead animal model).
Arm B: ''See one, do one'' cohort; Recruits to Arm B will witness an EVD placement as performed by an experienced surgeon, after which they will attempt to perform an EVD procedure on their own, using the aforementioned 3D-printed skull model. This mimics the ''see one, do one'' paradigm prevalent in surgical training.	Other: ''See one, do one'' approach; The participants watch an experienced surgeon perform the EVD placement, after which the participants attempt to perform the procedure independantly on the skull model.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of catheter placement	The placement of the catheter will be analysed by blinded assessors. Outcome: is the catheter in the ventricle (yes/no).	immediately upon completion of the procedure
Speed of performing the procedure	The time needed to complete the procedure will be recorded in seconds by blinded assessors.	immediately upon completion of the procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
Subjective survey	To be taken immediately before and immediately after performing the EVD insertion

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz
• Collaborators: University of Oxford
• Investigators: Study Director: Alexander L Green, MD, University of Oxford

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: December 6, 2016
• First Submitted That Met QC Criteria: December 7, 2016
• First Posted (Estimate): December 9, 2016

Study Record Updates

• Last Update Posted (Estimate): January 20, 2017
• Last Update Submitted That Met QC Criteria: January 18, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Medical education; simulation; neurosurgical education; Simulation laboratory; Ventricular drain
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hemorrhage; Hydrocephalus
• Other Study ID Numbers: SimLab_SSP_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No