Simulation Efficacy in Neurosurgical Education

Hydrocephalus Clinical Trial

— SENSE  

Official title:

Investigating the Efficacy of Simulation Curricula in Neurosurgical Education

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02988154
• Other study ID #: SimLab_SSP_01
• Status: Recruiting
• Phase: N/A
• First received: December 6, 2016
• Last updated: January 18, 2017
• Start date: June 2016

Study information

• Verified date: January 2017
• Source: Johannes Gutenberg University Mainz
• Contact: Amr Nimer Amr, MD
• Phone: 0049 6131 17 7331
• Email: amr[@]uni-mainz.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• never performed EVD placements before

Exclusion Criteria:

• any surgical experience with EVD placement

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Educational
• Hemorrhage
• Hydrocephalus
• Intraventricular Hemorrhage
• Simulation

Intervention

Other:
• Simulation training
Simulation training (computer simulation of the procedure, followed by simulation on a dead animal model).
• ''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.

Locations

Country	Name	City	State
Germany	University of Mainz / Department of Neurosurgery	Mainz	Rheinland Pfalz

Sponsors (2)

Lead Sponsor	Collaborator
Johannes Gutenberg University Mainz	University of Oxford

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Subjective survey		To be taken immediately before and immediately after performing the EVD insertion