EducationalSENSENCT02988154
Simulation Efficacy in Neurosurgical Education
An observational study of Educational and Simulation, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
This study aims to investigate the efficacy of simulation in neurosurgical training. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Educational, Simulation, Hydrocephalus
- What is being tested?
- Simulation training and ''See one, do one'' approach
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2016to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The recruits to the study are inexperienced surgical trainees and/or interns and students who have never performed EVD placements before.
Who may be able to join
- never performed EVD placements before
Who cannot join
- any surgical experience with EVD placement
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Mainz / Department of Neurosurgery
Mainz, Rhineland-Palatinate, 55131
Amr Nimer Amr, 06131 177331, amr@uni-mainz.de
Eleftherios Archavlis, MD, 06131 177331, eleftherios.archavlis@unimedizin-mainz.de
About this study
Official title: Investigating the Efficacy of Simulation Curricula in Neurosurgical Education
This study aims to investigate the efficacy of simulation in neurosurgical training.
Read the 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:
- 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.
- Conditions
- Educational, Simulation, Hydrocephalus, Intraventricular Hemorrhage
- Being tested
- Simulation training, ''See one, do one'' approach
- Keywords
- Medical education, simulation, neurosurgical education, Simulation laboratory, Ventricular drain
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation trainingOther
Simulation training (computer simulation of the procedure, followed by simulation on a dead animal model).
''See one, do one'' approachOther
The participants watch an experienced surgeon perform the EVD placement, after which the participants attempt to perform the procedure independantly on the skull model.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: ''See one, do one'' approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of catheter placement
The placement of the catheter will be analysed by blinded assessors. Outcome: is the catheter in the ventricle (yes/no).
Measured: 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.
Measured: immediately upon completion of the procedure
Secondary outcomes (1)
Subjective survey
Measured: To be taken immediately before and immediately after performing the EVD insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EducationalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Principal investigator, A. Nimer Amr, Johannes Gutenberg University Mainz
- Investigators
- Alexander L Green, MD, Study director, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988154
- Sponsor's protocol ID
- SimLab_SSP_01
- Acronym
- SENSE
- Status last verified
- Jan 2017
- First submitted
- 6 Dec 2016
- Last updated
- 20 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of Simulation Curricula in Neurosurgical Education
- ClinicalTrials.gov ID
- NCT02988154
- Acronym / sponsor ID
- SENSE / SimLab_SSP_01
- Conditions
- Educational, Simulation, Hydrocephalus, Intraventricular Hemorrhage
- Keywords
- Medical education, simulation, neurosurgical education, Simulation laboratory, Ventricular drain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- Jun 2016
- Primary completion
- Jan 2017 (estimated)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the efficacy of simulation in neurosurgical training.
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:
- 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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Simulation training cohort | – | Other: Simulation trainingRecruits 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. |
| Arm B: ''See one, do one'' cohort | – | Other: ''See one, do one'' approachRecruits 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The recruits to the study are inexperienced surgical trainees and/or interns and students who have never performed EVD placements before.
Key inclusion criteria (1 listed)
- never performed EVD placements before
Key exclusion criteria (1 listed)
- any surgical experience with EVD placement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation trainingSimulation training (computer simulation of the procedure, followed by simulation on a dead animal model). | Other | Arm A: Simulation training cohort |
| ''See one, do one'' approachThe participants watch an experienced surgeon perform the EVD placement, after which the participants attempt to perform the procedure independantly on the skull model. | Other | Arm B: ''See one, do one'' cohort |
Primary outcome
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.
1 secondary outcome
Subjective survey
Time frame: To be taken immediately before and immediately after performing the EVD insertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander L Green, MD study director
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Educational and Simulation, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr Nimer Amr, MD (0049 6131 17 7331, amr@uni-mainz.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of catheter placement (time frame: immediately upon completion of the procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2017.