Patient SimulationNCT03434002
Virtual Reality Simulation for Teaching and Assessment of Anesthesia Crisis Management
A study testing Training by Virtual Reality Simulation and Training by Mannequin Based Simulation in people with Patient Simulation, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
In this study, Investigators are going to develop and test a device to apply virtual reality simulation to improve and help for teaching and assessment of anesthesia crisis management. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Patient Simulation
- What is being tested?
- Training by Virtual Reality Simulation and Training by Mannequin Based Simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2018to Jan 2020
- Phase
- Interventional
- 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
Who may be able to join
- Anesthesia resident or fellow volunteers from University of Toronto
Who cannot join
- Unwilling to enter the study
- Previous experience with simulator based teaching on local anesthetic systemic toxicity
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Vincent Chan, 416-603-5118, vincent.chan@uhn.ca
Edward Kim
About this study
In this study, Investigators are going to develop and test a device to apply virtual reality simulation to improve and help for teaching and assessment of anesthesia crisis management.
Read the detailed description
Competency based medical education (CBME) is an outcomes-based approach to the design, implementation, assessment, and evaluation of medical education. The goals of Competency Based Medical Education are to improve patient safety, patient health outcomes, and enhance the competence and performance of individuals, groups and teams. Simulation-based training is a proven effective method to improve the skills and competency of the student by permit-ting repetitive practice before an actual procedure is performed on real patients.
e Virtual reality simulation has been used successfully to teach technical skills such as laparoscopic surgery, carotid stenting, gall bladder surgery, and knee arthroscopy.
The specific aims of this project are:
- Build a multi-user, multi-site virtual reality simulator for anesthesia management and team training
- Evaluate the simulation as a tool for competency based medical education
- Compare the effectiveness of the simulator with mannequin based simulator for competency based medical education.
- Conditions
- Patient Simulation
- Being tested
- Training by Virtual Reality Simulation, Training by Mannequin Based Simulation
- Keywords
- Virtual Reality Simulation, Teaching and Assessment, Anesthesia Crisis Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training by Virtual Reality SimulationOther
Those Randomized 15 residents will be receive Local Anesthetic Systemic Toxicity simulation training by Virtual Reality simulation and after two weeks, they will be evaluated by investigators by using the same performance evaluation tool.
Training by Mannequin Based SimulationOther
Randomized other 15 residents will be receive Local Anesthetic Systemic Toxicity simulation training by mannequin based simulation and after two weeks, they will be evaluated by investigators by using the same performance evaluation tool.
| Study group | Role | What they receive |
|---|---|---|
| Arm-A | Experimental | Randomized 15 residents out of 30 Post Graduate Year 1 or 2 anesthesia residents (not involved in initial Virtual Reality testing) will be receive Local Anesthetic Systemic Toxicity simulation training by Virtual Reality simulation Receives: Other: Training by Virtual Reality Simulation |
| Arm-B | Experimental | Randomized other 15 residents out of 30 Post Graduate Year 1 or 2 anesthesia residents (not involved in initial Virtual Reality testing) will be receive Local Anesthetic Systemic Toxicity simulation training by mannequin based simulation Receives: Other: Training by Mannequin Based Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of tasks correctly performed
The primary outcome in performance evaluation is the number of tasks correctly performed during management of the Local Anesthetic Systemic Toxicity event. Investigators will use the same performance evaluation tool.
The performance evaluation tool will assess the trainee's performance (i.e., medical management of Local Anesthetic Systemic Toxicity) per performance evaluation tool
Measured: 1 hour
Secondary outcomes (1)
use the Anesthesiologists' Non-Technical Skills (ANTS) tool
The Investigators will use the anesthesiologists' non-technical skills (ANTS) tool in the Local Anesthetic Systemic Toxicity Event (Data Collection Tools, Supplemental Digital Content 2, http://links.lww.com/AAP/A45) as described by Neal.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start1 Jan 2018
- Primary completionAug 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Patient SimulationStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- 1. building the technical components for interaction within the virtual reality environment (phase 1); 2. application of this virtual reality in medical training (phase 2) and 3. measurement of training effectiveness with this Virtual Reality simulator against mannequin based training (phase 3).
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Chan, Principal investigator, Toronto Western Hospital, University Health Network, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434002
- Sponsor's protocol ID
- 15-9985
- Status last verified
- Feb 2018
- First submitted
- 17 Jan 2018
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
ACGME Outcome Project: Table of Toolbox Methods. (Accessed 1 Sept 2015, at http://njms.rutgers.edu/culweb/medical/documents/ToolboxofAssessmentMethods.pdf).
McGaghie WC, Issenberg SB, Petrusa ER, Scalese RJ. A critical review of simulation-based medical education research: 2003-2009. Med Educ. 2010 Jan;44(1):50-63. doi: 10.1111/j.1365-2923.2009.03547.x.
PubMed 20078756Salas E, DiazGranados D, Weaver SJ, King H. Does team training work? Principles for health care. Acad Emerg Med. 2008 Nov;15(11):1002-9. doi: 10.1111/j.1553-2712.2008.00254.x. Epub 2008 Oct 1.
PubMed 18828828Sorbero ME, Farley DO, Mattke S, Lovejoy S. Outcome measures for effective teamwork in inpatient care (RAND technical report TR-462-AHRQ). Arlington, VA: RAND Corporation, 2008.
Ziv A, Ben-David S, Ziv M. Simulation based medical education: an opportunity to learn from errors. Med Teach. 2005 May;27(3):193-9. doi: 10.1080/01421590500126718.
PubMed 16011941Alonso A, Baker DP, Holtzman A, et al. Reducing medical error in the military health system: How can team training help? Hum Resour Manag Rev. 2006;16:396-415.
Leblanc VR. Review article: simulation in anesthesia: state of the science and looking forward. Can J Anaesth. 2012 Feb;59(2):193-202. doi: 10.1007/s12630-011-9638-8. Epub 2011 Dec 17.
PubMed 22179792Cook DA, Hatala R, Brydges R, Zendejas B, Szostek JH, Wang AT, Erwin PJ, Hamstra SJ. Technology-enhanced simulation for health professions education: a systematic review and meta-analysis. JAMA. 2011 Sep 7;306(9):978-88. doi: 10.1001/jama.2011.1234.
PubMed 21900138Grantcharov TP, Kristiansen VB, Bendix J, Bardram L, Rosenberg J, Funch-Jensen P. Randomized clinical trial of virtual reality simulation for laparoscopic skills training. Br J Surg. 2004 Feb;91(2):146-50. doi: 10.1002/bjs.4407.
PubMed 14760660Nguyen N, Elliott JO, Watson WD, Dominguez E. Simulation Improves Nontechnical Skills Performance of Residents During the Perioperative and Intraoperative Phases of Surgery. J Surg Educ. 2015 Sep-Oct;72(5):957-63. doi: 10.1016/j.jsurg.2015.03.005. Epub 2015 Apr 21.
PubMed 25911460Neal JM, Hsiung RL, Mulroy MF, Halpern BB, Dragnich AD, Slee AE. ASRA checklist improves trainee performance during a simulated episode of local anesthetic systemic toxicity. Reg Anesth Pain Med. 2012 Jan-Feb;37(1):8-15. doi: 10.1097/AAP.0b013e31823d825a.
PubMed 22157743Koutantji, Maria, et al.
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Simulation for Teaching and Assessment of Anesthesia Crisis Management
- ClinicalTrials.gov ID
- NCT03434002
- Acronym / sponsor ID
- 15-9985
- Conditions
- Patient Simulation
- Keywords
- Virtual Reality Simulation, Teaching and Assessment, Anesthesia Crisis Management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 15 Feb 2018 (actual)
- 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.
In this study, Investigators are going to develop and test a device to apply virtual reality simulation to improve and help for teaching and assessment of anesthesia crisis management.
Detailed description
Competency based medical education (CBME) is an outcomes-based approach to the design, implementation, assessment, and evaluation of medical education. The goals of Competency Based Medical Education are to improve patient safety, patient health outcomes, and enhance the competence and performance of individuals, groups and teams. Simulation-based training is a proven effective method to improve the skills and competency of the student by permit-ting repetitive practice before an actual procedure is performed on real patients.
e Virtual reality simulation has been used successfully to teach technical skills such as laparoscopic surgery, carotid stenting, gall bladder surgery, and knee arthroscopy.
The specific aims of this project are:
- Build a multi-user, multi-site virtual reality simulator for anesthesia management and team training
- Evaluate the simulation as a tool for competency based medical education
- Compare the effectiveness of the simulator with mannequin based simulator for competency based medical education.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1. building the technical components for interaction within the virtual reality environment (phase 1); 2. application of this virtual reality in medical training (phase 2) and 3. measurement of training effectiveness with this Virtual Reality simulator against mannequin based training (phase 3).
| Arm | Type | Receives |
|---|---|---|
| Arm-A | Experimental | Other: Training by Virtual Reality SimulationRandomized 15 residents out of 30 Post Graduate Year 1 or 2 anesthesia residents (not involved in initial Virtual Reality testing) will be receive Local Anesthetic Systemic Toxicity simulation training by Virtual Reality simulation |
| Arm-B | Experimental | Other: Training by Mannequin Based SimulationRandomized other 15 residents out of 30 Post Graduate Year 1 or 2 anesthesia residents (not involved in initial Virtual Reality testing) will be receive Local Anesthetic Systemic Toxicity simulation training by mannequin based simulation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Anesthesia resident or fellow volunteers from University of Toronto
Key exclusion criteria (2 listed)
- Unwilling to enter the study
- Previous experience with simulator based teaching on local anesthetic systemic toxicity
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 |
|---|---|---|
| Training by Virtual Reality SimulationThose Randomized 15 residents will be receive Local Anesthetic Systemic Toxicity simulation training by Virtual Reality simulation and after two weeks, they will be evaluated by investigators by using the same performance evaluation tool. | Other | Arm-A |
| Training by Mannequin Based SimulationRandomized other 15 residents will be receive Local Anesthetic Systemic Toxicity simulation training by mannequin based simulation and after two weeks, they will be evaluated by investigators by using the same performance evaluation tool. | Other | Arm-B |
Primary outcome
Number of tasks correctly performed
Time frame: 1 hour
The primary outcome in performance evaluation is the number of tasks correctly performed during management of the Local Anesthetic Systemic Toxicity event. Investigators will use the same performance evaluation tool. The performance evaluation tool will assess the trainee's performance (i.e., medical management of Local Anesthetic Systemic Toxicity) per performance evaluation tool
1 secondary outcome
use the Anesthesiologists' Non-Technical Skills (ANTS) tool
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- BackgroundACGME Outcome Project: Table of Toolbox Methods. (Accessed 1 Sept 2015, at http://njms.rutgers.edu/culweb/medical/documents/ToolboxofAssessmentMethods.pdf).
- Results publication: PubMed 20078756McGaghie WC, Issenberg SB, Petrusa ER, Scalese RJ. A critical review of simulation-based medical education research: 2003-2009. Med Educ. 2010 Jan;44(1):50-63. doi: 10.1111/j.1365-2923.2009.03547.x.
- Results publication: PubMed 18828828Salas E, DiazGranados D, Weaver SJ, King H. Does team training work? Principles for health care. Acad Emerg Med. 2008 Nov;15(11):1002-9. doi: 10.1111/j.1553-2712.2008.00254.x. Epub 2008 Oct 1.
- Results publicationSorbero ME, Farley DO, Mattke S, Lovejoy S. Outcome measures for effective teamwork in inpatient care (RAND technical report TR-462-AHRQ). Arlington, VA: RAND Corporation, 2008.
- Results publication: PubMed 16011941Ziv A, Ben-David S, Ziv M. Simulation based medical education: an opportunity to learn from errors. Med Teach. 2005 May;27(3):193-9. doi: 10.1080/01421590500126718.
- Results publicationAlonso A, Baker DP, Holtzman A, et al. Reducing medical error in the military health system: How can team training help? Hum Resour Manag Rev. 2006;16:396-415.
- Results publication: PubMed 22179792Leblanc VR. Review article: simulation in anesthesia: state of the science and looking forward. Can J Anaesth. 2012 Feb;59(2):193-202. doi: 10.1007/s12630-011-9638-8. Epub 2011 Dec 17.
- Results publication: PubMed 21900138Cook DA, Hatala R, Brydges R, Zendejas B, Szostek JH, Wang AT, Erwin PJ, Hamstra SJ. Technology-enhanced simulation for health professions education: a systematic review and meta-analysis. JAMA. 2011 Sep 7;306(9):978-88. doi: 10.1001/jama.2011.1234.
- Results publication: PubMed 14760660Grantcharov TP, Kristiansen VB, Bendix J, Bardram L, Rosenberg J, Funch-Jensen P. Randomized clinical trial of virtual reality simulation for laparoscopic skills training. Br J Surg. 2004 Feb;91(2):146-50. doi: 10.1002/bjs.4407.
- Results publication: PubMed 25911460Nguyen N, Elliott JO, Watson WD, Dominguez E. Simulation Improves Nontechnical Skills Performance of Residents During the Perioperative and Intraoperative Phases of Surgery. J Surg Educ. 2015 Sep-Oct;72(5):957-63. doi: 10.1016/j.jsurg.2015.03.005. Epub 2015 Apr 21.
- Results publication: PubMed 22157743Neal JM, Hsiung RL, Mulroy MF, Halpern BB, Dragnich AD, Slee AE. ASRA checklist improves trainee performance during a simulated episode of local anesthetic systemic toxicity. Reg Anesth Pain Med. 2012 Jan-Feb;37(1):8-15. doi: 10.1097/AAP.0b013e31823d825a.
- Results publicationKoutantji, Maria, et al.
- Individual participant dataSharing planned: Undecided
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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.
Vincent Chan principal investigator
Toronto Western Hospital, University Health Network, University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training by Virtual Reality Simulation and Training by Mannequin Based Simulation in people with Patient Simulation, run by University Health Network, Toronto at 1 site in Canada.
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 2 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 15 Feb 2018. 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 Canada. 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 Vincent Chan (416-603-5118, vincent.chan@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of tasks correctly performed (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03434002, which also lists 12 linked publications.
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 15 Feb 2018; AzTrials last refreshed its copy on 26 Oct 2026.