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Trial record 17 of 24 for:    Recruiting, Not yet recruiting, Available Studies | "Hydrocephalus"

Simulation Efficacy in Neurosurgical Education (SENSE)

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ClinicalTrials.gov Identifier: NCT02988154
Recruitment Status : Recruiting
First Posted : December 9, 2016
Last Update Posted : January 20, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

December 6, 2016
December 9, 2016
January 20, 2017
June 2016
January 2017   (Final data collection date for primary outcome measure)
  • Accuracy of catheter placement [ Time Frame: immediately upon completion of the procedure ]
    The placement of the catheter will be analysed by blinded assessors. Outcome: is the catheter in the ventricle (yes/no).
  • Speed of performing the procedure [ Time Frame: immediately upon completion of the procedure ]
    The time needed to complete the procedure will be recorded in seconds by blinded assessors.
Same as current
Complete list of historical versions of study NCT02988154 on ClinicalTrials.gov Archive Site
Subjective survey [ Time Frame: To be taken immediately before and immediately after performing the EVD insertion ]
Same as current
Not Provided
Not Provided
 
Simulation Efficacy in Neurosurgical Education
Investigating the Efficacy of Simulation Curricula in Neurosurgical Education
This study aims to investigate the efficacy of simulation in neurosurgical training.

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.

Observational
Observational Model: Other
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
The recruits to the study are inexperienced surgical trainees and/or interns and students who have never performed EVD placements before.
  • Educational
  • Simulation
  • Hydrocephalus
  • Intraventricular Hemorrhage
  • Other: Simulation training
    Simulation training (computer simulation of the procedure, followed by simulation on a dead animal model).
  • 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.
  • 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.
    Intervention: 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.
    Intervention: Other: ''See one, do one'' approach
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Not Provided
January 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • never performed EVD placements before

Exclusion Criteria:

  • any surgical experience with EVD placement
Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact: Amr Nimer Amr, MD 0049 6131 17 7331 amr@uni-mainz.de
Contact: Florian Ringel, MD 0049 6131 17 7331 florian.ringel@unimedizin-mainz.de
Germany
 
 
NCT02988154
SimLab_SSP_01
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
A. Nimer Amr, Johannes Gutenberg University Mainz
Johannes Gutenberg University Mainz
University of Oxford
Study Director: Alexander L Green, MD University of Oxford
Johannes Gutenberg University Mainz
January 2017