Virtual Simulation Versus High-Fidelity Mannequin Simulation

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)
Overall Status
Approved for marketing
CT.gov ID
NCT05041049
Collaborator
(none)

Study Details

Study Description

Brief 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. 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: Comparing Visual Reality to High-fidelity mannequin Stimulation

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. 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.

Study Design

Study Type:
Expanded Access
Official Title:
Virtual Simulation Versus High-Fidelity Mannequin Simulation to Train Anesthesia Residents

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Participants will be included if they are residents enrolled in the Anesthesia Residency program at the McGill University
    Exclusion Criteria:
    • . Participants will be excluded if they refuse or if they have a history of Virtual Reality Induced Symptoms and Effects (VRISE).

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • McGill University Health Centre/Research Institute of the McGill University Health Centre

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gianluca Bertolizio, Associate Professor, McGill University Health Centre/Research Institute of the McGill University Health Centre
    ClinicalTrials.gov Identifier:
    NCT05041049
    Other Study ID Numbers:
    • 2021-7663
    First Posted:
    Sep 10, 2021
    Last Update Posted:
    Jan 28, 2022
    Last Verified:
    Jan 1, 2022
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 28, 2022