Comparing Visual Reality to High-fidelity Mannequin StimulationNCT05041049
Virtual Simulation Versus High-Fidelity Mannequin Simulation
A study testing Comparing Visual Reality to High-fidelity mannequin Stimulation in people with Comparing Visual Reality to High-fidelity Mannequin Stimulation, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
Trial summary
Background. Despite remarkable progress, pediatric anesthesia-related mortality remains 2 to 30 times higher than in adults. Non-technical skills rather than a lack of expertise were identified to be the main cause of errors in medicine, particularly in emergency situations. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Comparing Visual Reality to High-fidelity Mannequin Stimulation
- What is being tested?
- Comparing Visual Reality to High-fidelity mannequin Stimulation
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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
- Child, Adult, Older adult
Who may be able to join
- Participants will be included if they are residents enrolled in the Anesthesia Residency program at the McGill University
Who cannot join
- . Participants will be excluded if they refuse or if they have a history of Virtual Reality Induced Symptoms and Effects (VRISE).
About this study
Official title: Virtual Simulation Versus High-Fidelity Mannequin Simulation to Train Anesthesia Residents
Background. Despite remarkable progress, pediatric anesthesia-related mortality remains 2 to 30 times higher than in adults. Non-technical skills rather than a lack of expertise were identified to be the main cause of errors in medicine, particularly in emergency situations. As a consequence, interactive computer-based sessions and high-fidelity simulation have been progressively integrated into pediatric training programs. The setup of a suitable simulation center, however, is expensive and requires space, logistical support and manpower. Virtual reality (VR) is a technological innovation that has been increasingly integrated into clinical practice and medical training. Comparing to the mannequin-based simulation, theoretical advantages of VR are the inherent highly immersive quality, the independent participation with no need of other participants, the ease of multiple repetitions, the lack of time or space constrains, and the reduced costs. Non-technical and operational skills appear to improve significantly after VR training. To date, information on the efficacy of VR in the anesthesia training are limited.
Objectives. The primary aim will be to compare the improvement of non-technical skills after one simulation session between VR and high-fidelity mannequin simulation (HFS). Secondary aims will be to compare the overall anesthesia resident non-technical skills performance between VR and HFS, and to determine confidence in the simulation training of each participant.
Read more
Methods. This is a prospective, randomized, non-inferiority study. Eighteen residents in anesthesia (R1-R5) will be enrolled. Participants of each year will be randomly allocated to be involved in either a VR or a HFS training. The scenario will be the same for both VR and HFS groups. Within two weeks after the training session, all participants will undergo a different, mannequin-based HFS scenario.
After each simulation, resident performance will be assessed using the Anaesthetists' Non-Technical Skills scale and the Ottawa Crisis Resource Management Global Rating Scale. Evaluators will also perform a summary evaluation with the Managing Emergencies in Pediatric Anesthesia Global Rating Scale.
Resident's satisfaction will be measured with a post-assessment trainee survey scale.
Significance. Should the virtual reality demonstrate to be as efficient as mannequin-based simulation, it will be integrated into the residency curriculum and used for resident training and medical education in institutions that have limited access to a simulation center.
Read the detailed description
Background. Despite remarkable progress, pediatric anesthesia-related mortality remains 2 to 30 times higher than in adults. Non-technical skills rather than a lack of expertise were identified to be the main cause of errors in medicine, particularly in emergency situations. As a consequence, interactive computer-based sessions and high-fidelity simulation have been progressively integrated into pediatric training programs. The setup of a suitable simulation center, however, is expensive and requires space, logistical support and manpower. Virtual reality (VR) is a technological innovation that has been increasingly integrated into clinical practice and medical training. Comparing to the mannequin-based simulation, theoretical advantages of VR are the inherent highly immersive quality, the independent participation with no need of other participants, the ease of multiple repetitions, the lack of time or space constrains, and the reduced costs. Non-technical and operational skills appear to improve significantly after VR training. To date, information on the efficacy of VR in the anesthesia training are limited.
Objectives. The primary aim will be to compare the improvement of non-technical skills after one simulation session between VR and high-fidelity mannequin simulation (HFS). Secondary aims will be to compare the overall anesthesia resident non-technical skills performance between VR and HFS, and to determine confidence in the simulation training of each participant.
Methods. This is a prospective, randomized, non-inferiority study. Twenty residents in anesthesia (R1-R5) will be enrolled. Participants of each year will be randomly allocated to be involved in either a VR or a HFS training. The scenario will be the same for both VR and HFS groups. Within three weeks after the training session, all participants will undergo a different, mannequin-based HFS scenario.
After each simulation, resident performance will be assessed using the Anaesthetists' Non-Technical Skills scale and the Ottawa Crisis Resource Management Global Rating Scale. Evaluators will also perform a summary evaluation with the Managing Emergencies in Pediatric Anesthesia Global Rating Scale.
Resident's satisfaction will be measured with a post-assessment trainee survey scale.
Significance. Should the virtual reality demonstrate to be as efficient as mannequin-based simulation, it will be integrated into the residency curriculum and used for resident training and medical education in institutions that have limited access to a simulation center.
- Being tested
- Comparing Visual Reality to High-fidelity mannequin Stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparing Visual Reality to High-fidelity mannequin StimulationDevice
Also called Comparing VR to HFS, To assess whether VR is as effective as mannequin-based HFS in anesthesia resident training.
This is a prospective, randomized, non-inferiority study. VR will be compared to HFS, which will be considered the a priori gold standard for residents simulation training.
The study will be divided into two phases. In the pre-test phase, participants will be randomly allocated to receive either a VR or HFS scenario (scenario 1, see below). In the post-test phase, all participants (regardless the initial grouping) will undergo a HFS scenario (scenario 2, see below).
All scenarios have been chosen from critical events published by the Society of Pediatric Anesthesia48 and adult sources49.
The study will be conducted at the McGill University Health Center - Research Institute (MUHC-RI).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Comparing Visual Reality to High-fidelity Mannequin StimulationStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Bertolizio, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041049
- Sponsor's protocol ID
- 2021-7663
- Status last verified
- Apr 2023
- First submitted
- 2 Sep 2021
- Last updated
- 18 Apr 2023
- Results posted
- No
Publications
Bertolizio G, Paquet C, Buu N, Engelhardt T, Shafiepour DS, Azzam MA, Garbin M, White C, Wasserman S, Gu Y, Crooks S, Nickel C, Sohi R, Power D, LeBlanc V, Poenaru D. Stress During Virtual Reality and High-Fidelity Simulation in Anesthesia Trainees: A Randomized Controlled Trial. Simul Healthc. 2026 Jun 4. doi: 10.1097/SIH.0000000000000946. Online ahead of print.
PubMed 42240590Bertolizio G, Buu N, Paquet C, Engelhardt T, Azzam M, Shafiepour DS, Garbin M, White C, Wasserman S, Gu Y, Crooks S, Nickel C, Sohi R, Power D, Poenaru D. Immersive virtual reality versus high-fidelity simulation to teach anesthesiology nontechnical skills: a randomized controlled noninferiority trial. Can J Anaesth. 2026 Mar;73(3):261-272. doi: 10.1007/s12630-026-03111-9. Epub 2026 May 5. English, French.
PubMed 42087045
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Simulation Versus High-Fidelity Mannequin Simulation to Train Anesthesia Residents
- ClinicalTrials.gov ID
- NCT05041049
- Acronym / sponsor ID
- 2021-7663
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- First posted
- 10 Sep 2021 (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.
Background. Despite remarkable progress, pediatric anesthesia-related mortality remains 2 to 30 times higher than in adults. Non-technical skills rather than a lack of expertise were identified to be the main cause of errors in medicine, particularly in emergency situations. As a consequence, interactive computer-based sessions and high-fidelity simulation have been progressively integrated into pediatric training programs. The setup of a suitable simulation center, however, is expensive and requires space, logistical support and manpower. Virtual reality (VR) is a technological innovation that has been increasingly integrated into clinical practice and medical training. Comparing to the mannequin-based simulation, theoretical advantages of VR are the inherent highly immersive quality, the independent participation with no need of other participants, the ease of multiple repetitions, the lack of time or space constrains, and the reduced costs. Non-technical and operational skills appear to improve significantly after VR training. To date, information on the efficacy of VR in the anesthesia training are limited.
Objectives. The primary aim will be to compare the improvement of non-technical skills after one simulation session between VR and high-fidelity mannequin simulation (HFS). Secondary aims will be to compare the overall anesthesia resident non-technical skills performance between VR and HFS, and to determine confidence in the simulation training of each participant.
Methods. This is a prospective, randomized, non-inferiority study. Eighteen residents in anesthesia (R1-R5) will be enrolled. Participants of each year will be randomly allocated to be involved in either a VR or a HFS training. The scenario will be the same for both VR and HFS groups. Within two weeks after the training session, all participants will undergo a different, mannequin-based HFS scenario.
After each simulation, resident performance will be assessed using the Anaesthetists' Non-Technical Skills scale and the Ottawa Crisis Resource Management Global Rating Scale. Evaluators will also perform a summary evaluation with the Managing Emergencies in Pediatric Anesthesia Global Rating Scale.
Resident's satisfaction will be measured with a post-assessment trainee survey scale.
Significance. Should the virtual reality demonstrate to be as efficient as mannequin-based simulation, it will be integrated into the residency curriculum and used for resident training and medical education in institutions that have limited access to a simulation center.
Detailed description
Background. Despite remarkable progress, pediatric anesthesia-related mortality remains 2 to 30 times higher than in adults. Non-technical skills rather than a lack of expertise were identified to be the main cause of errors in medicine, particularly in emergency situations. As a consequence, interactive computer-based sessions and high-fidelity simulation have been progressively integrated into pediatric training programs. The setup of a suitable simulation center, however, is expensive and requires space, logistical support and manpower. Virtual reality (VR) is a technological innovation that has been increasingly integrated into clinical practice and medical training. Comparing to the mannequin-based simulation, theoretical advantages of VR are the inherent highly immersive quality, the independent participation with no need of other participants, the ease of multiple repetitions, the lack of time or space constrains, and the reduced costs. Non-technical and operational skills appear to improve significantly after VR training. To date, information on the efficacy of VR in the anesthesia training are limited.
Objectives. The primary aim will be to compare the improvement of non-technical skills after one simulation session between VR and high-fidelity mannequin simulation (HFS). Secondary aims will be to compare the overall anesthesia resident non-technical skills performance between VR and HFS, and to determine confidence in the simulation training of each participant.
Methods. This is a prospective, randomized, non-inferiority study. Twenty residents in anesthesia (R1-R5) will be enrolled. Participants of each year will be randomly allocated to be involved in either a VR or a HFS training. The scenario will be the same for both VR and HFS groups. Within three weeks after the training session, all participants will undergo a different, mannequin-based HFS scenario.
After each simulation, resident performance will be assessed using the Anaesthetists' Non-Technical Skills scale and the Ottawa Crisis Resource Management Global Rating Scale. Evaluators will also perform a summary evaluation with the Managing Emergencies in Pediatric Anesthesia Global Rating Scale.
Resident's satisfaction will be measured with a post-assessment trainee survey scale.
Significance. Should the virtual reality demonstrate to be as efficient as mannequin-based simulation, it will be integrated into the residency curriculum and used for resident training and medical education in institutions that have limited access to a simulation center.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participants will be included if they are residents enrolled in the Anesthesia Residency program at the McGill University
Key exclusion criteria (1 listed)
- . Participants will be excluded if they refuse or if they have a history of Virtual Reality Induced Symptoms and Effects (VRISE).
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 |
|---|---|---|
| Comparing Visual Reality to High-fidelity mannequin StimulationAlso: Comparing VR to HFS, To assess whether VR is as effective as mannequin-based HFS in anesthesia resident training.This is a prospective, randomized, non-inferiority study. VR will be compared to HFS, which will be considered the a priori gold standard for residents simulation training. The study will be divided into two phases. In the pre-test phase, participants will be randomly allocated to receive either a VR or HFS scenario (scenario 1, see below). In the post-test phase, all participants (regardless the initial grouping) will undergo a HFS scenario (scenario 2, see below). All scenarios have been chosen from critical events published by the Society of Pediatric Anesthesia48 and adult sources49. The study will be conducted at the McGill University Health Center - Research Institute (MUHC-RI). | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 42240590Bertolizio G, Paquet C, Buu N, Engelhardt T, Shafiepour DS, Azzam MA, Garbin M, White C, Wasserman S, Gu Y, Crooks S, Nickel C, Sohi R, Power D, LeBlanc V, Poenaru D. Stress During Virtual Reality and High-Fidelity Simulation in Anesthesia Trainees: A Randomized Controlled Trial. Simul Healthc. 2026 Jun 4. doi: 10.1097/SIH.0000000000000946. Online ahead of print.
- Derived from this study: PubMed 42087045Bertolizio G, Buu N, Paquet C, Engelhardt T, Azzam M, Shafiepour DS, Garbin M, White C, Wasserman S, Gu Y, Crooks S, Nickel C, Sohi R, Power D, Poenaru D. Immersive virtual reality versus high-fidelity simulation to teach anesthesiology nontechnical skills: a randomized controlled noninferiority trial. Can J Anaesth. 2026 Mar;73(3):261-272. doi: 10.1007/s12630-026-03111-9. Epub 2026 May 5. English, French.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Comparing Visual Reality to High-fidelity mannequin Stimulation in people with Comparing Visual Reality to High-fidelity Mannequin Stimulation, run by McGill University Health Centre/Research Institute of the McGill University Health Centre.
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 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05041049, which also lists 2 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 18 Apr 2023.