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Trial record 20 of 29 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:
University of Oxford
Information provided by (Responsible Party):
A. Nimer Amr, Johannes Gutenberg University Mainz

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

Condition or disease Intervention/treatment
Educational Simulation Hydrocephalus Intraventricular Hemorrhage 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
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Investigating the Efficacy of Simulation Curricula in Neurosurgical Education
Study Start Date : June 2016
Estimated Primary Completion Date : January 2017


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.




Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. Subjective survey [ Time Frame: To be taken immediately before and immediately after performing the EVD insertion ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • never performed EVD placements before

Exclusion Criteria:

  • any surgical experience with EVD placement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02988154


Contacts
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

Locations
Germany
University of Mainz / Department of Neurosurgery Recruiting
Mainz, Rheinland Pfalz, Germany, 55131
Contact: Amr Nimer Amr    06131 177331    amr@uni-mainz.de   
Contact: Eleftherios Archavlis, MD    06131 177331    eleftherios.archavlis@unimedizin-mainz.de   
Principal Investigator: Amr Nimer         
Sub-Investigator: Eleftherios Archavlis         
Sponsors and Collaborators
Johannes Gutenberg University Mainz
University of Oxford
Investigators
Study Director: Alexander L Green, MD University of Oxford

Responsible Party: A. Nimer Amr, Investigator, Johannes Gutenberg University Mainz
ClinicalTrials.gov Identifier: NCT02988154     History of Changes
Other Study ID Numbers: SimLab_SSP_01
First Posted: December 9, 2016    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by A. Nimer Amr, Johannes Gutenberg University Mainz:
Medical education
simulation
neurosurgical education
Simulation laboratory
Ventricular drain

Additional relevant MeSH terms:
Hydrocephalus
Hemorrhage
Cerebral Hemorrhage
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases