Simulation Efficacy in Neurosurgical Education

NCT02988154 | Unknown

• 1 other identifier: SimLab_SSP_01
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Educational; Simulation; Hydrocephalus; Intraventricular Hemorrhage

Keywords

Medical education; simulation; neurosurgical education; Simulation laboratory; Ventricular drain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Subjective survey

  To be taken immediately before and immediately after performing the EVD insertion

Study Arms (2)

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

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

Interventions

Simulation training OTHER

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

Arm A: Simulation training cohort

''See one, do one'' approach OTHER

The participants watch an experienced surgeon perform the EVD placement, after which the participants attempt to perform the procedure independantly on the skull model.

Arm B: ''See one, do one'' cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• never performed EVD placements before

You may not qualify if:

• any surgical experience with EVD placement

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead
• University of Oxford: collaborator

Study Sites (1)

University of Mainz / Department of Neurosurgery

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Alexander L Green, MD

  University of Oxford

  STUDY DIRECTOR

Central Study Contacts

Amr Nimer Amr, MD

CONTACT

0049 6131 17 7331; amr@uni-mainz.de

Florian Ringel, MD

CONTACT

0049 6131 17 7331; florian.ringel@unimedizin-mainz.de

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 9, 2016
• Study Start: June 1, 2016
• Primary Completion: January 1, 2017
• Last Updated: January 20, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)