<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04451590</url>
  </required_header>
  <id_info>
    <org_study_id>108-2019</org_study_id>
    <nct_id>NCT04451590</nct_id>
  </id_info>
  <brief_title>Virtual Reality: a Teaching-learning Strategy for Cognitive Mastery in Airway Trauma Management</brief_title>
  <acronym>AW&amp;VR</acronym>
  <official_title>Virtual Reality: a Teaching-learning Strategy for Cognitive Mastery in Airway Trauma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Airway injury in patients is a high risk and complex medical crisis. Unfortunately, training&#xD;
      for airway management in injured patients is challenging. The most effective way of&#xD;
      practicing airway management is using mannequins. However, mannequin training is expensive&#xD;
      and only occasionally available to medical trainees.&#xD;
&#xD;
      The purpose of this study is to determine if Virtual Reality (VR) can be used to educate&#xD;
      medical students on airway injury management. VR training will involve managing the care of a&#xD;
      patient with an airway injury in an immersive, interactive VR hospital trauma bay. The&#xD;
      investigators will compare the knowledge gained from VR training vs. mannequin training. The&#xD;
      investigators will also investigate whether VR training teaches students faster than&#xD;
      mannequin training. In addition, the investigators will identify factors which might affect&#xD;
      learning from VR.&#xD;
&#xD;
      Medical students who choose to participate will be randomized (i.e. participant will have a&#xD;
      50% chance to be placed in either group) to be trained with VR or a mannequin. Participants&#xD;
      then will be trained on airway injury management using their assigned training approach. One&#xD;
      week later, all participants will be assessed on their airway injury management skills using&#xD;
      a mannequin. Before and after their sessions, participants will also be asked to complete a&#xD;
      questionnaire on their clinical decision-making. Participants who received VR training will&#xD;
      also complete a questionnaire about their experience with the VR training.&#xD;
&#xD;
      This study will help develop a new approach to airway management training which is cheaper&#xD;
      and more easily available to medical trainees than mannequin training. This educational tool&#xD;
      could lead to better treatment of airway trauma in future patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2021</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>An external assessor will score videos participants performing Airway Trauma Management using the Airway Injury Checklist on Core Decision Making Steps. The assessors will be blinded to intervention.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Traumatic Airway Injury Management Knowledge</measure>
    <time_frame>up to 24 hours before and up to 24 hours after practice sessions</time_frame>
    <description>Knowledge acquisition of traumatic airway injury management as assessed by the written Key Features Decision Making Checklist, Change from baseline (pre-training) knowledge to after practice session knowledge (post-training).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Application of Traumatic Airway Injury Management Knowledge</measure>
    <time_frame>7 days after practice session</time_frame>
    <description>Application of decision making concepts surrounding traumatic airway injury management as assessed by the Airway Injury Checklist of Core Decision Making Steps completed during participant performance of a simulated crisis assessment scenario.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Required Practice Sessions</measure>
    <time_frame>During the 1 day practice session</time_frame>
    <description>Identify whether VR or mannequin-based simulation practice require fewer practice sessions to achieve learning objectives.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Education, Medical</condition>
  <condition>Airway Management</condition>
  <condition>Students, Medical</condition>
  <condition>Virtual Reality</condition>
  <condition>Trauma Centers</condition>
  <condition>Manikins</condition>
  <arm_group>
    <arm_group_label>VR-based Simulation (Intervention)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Students will receive training on traumatic airway management using VR-based simulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mannequin-based Simulation (Control)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Students will receive training on traumatic airway management using mannequin-based simulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>VR-based simulation</intervention_name>
    <description>Participants will experience a novel interactive and immersive VR full size trauma bay with an adult patient and healthcare professionals. Immersed in the environment, learners undertake the decision-making steps in managing the medical care for a patient with an airway injury. Learners are first given the case scenario from which they form their own learning goals/plans. They then navigate through the scenario that will provide feedback depending on their actions in the form of either the patient's hemodynamic changes or prompts from healthcare avatars in the scenario. These feedback processes are built-in and designed to promote reflection and reorganization of the learner's decision-making strategies. As learning progresses, fewer prompts will be given. At the end of the scenario, evaluation algorithms pre-programmed into the VR-based simulation will be displayed.</description>
    <arm_group_label>VR-based Simulation (Intervention)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mannequin-based simulation</intervention_name>
    <description>Participants will experience a mannequin-based scenario practice which is the current gold standard in medical education. The trauma airway management scenario will match the VR environment and sequence of events.</description>
    <arm_group_label>Mannequin-based Simulation (Control)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 at time of consent&#xD;
&#xD;
          -  Medical student at U of T in 1st, 2nd or 3rd year&#xD;
&#xD;
          -  Able to attend two sessions a week apart&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of participant consent or capacity to give consent&#xD;
&#xD;
          -  History of significant motion sickness (during exposure to physical, visual and&#xD;
             virtual motion, cybersickness verbally declared by patient)&#xD;
&#xD;
          -  Visual/hearing impairments that affect abilities to listen/watch videos/VR video&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Alam Fahad, MD, M.Sc</last_name>
    <phone>416-480-4864</phone>
    <phone_ext>4798</phone_ext>
    <email>fahad.alam@sunnybrook.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lilia Kaustov, PhD</last_name>
    <phone>416-480-6100</phone>
    <phone_ext>89607</phone_ext>
    <email>lilia.kaustov@sunnybrook.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Fahad Alam, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>November 12, 2019</study_first_submitted>
  <study_first_submitted_qc>June 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>September 12, 2022</last_update_submitted>
  <last_update_submitted_qc>September 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04451590
org study id: 108-2019
nct id: NCT04451590
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Airway injury in patients is a high risk and complex medical crisis. Unfortunately, training
      for airway management in injured patients is challenging. The most effective way of
      practicing airway management is using mannequins. However, mannequin training is expensive
      and only occasionally available to medical trainees.

      The purpose of this study is to determine if Virtual Reality (VR) can be used to educate
      medical students on airway injury management. VR training will involve managing the care of a
      patient with an airway injury in an immersive, interactive VR hospital trauma bay. The
      investigators will compare the knowledge gained from VR training vs. mannequin training. The
      investigators will also investigate whether VR training teaches students faster than
      mannequin training. In addition, the investigators will identify factors which might affect
      learning from VR.

      Medical students who choose to participate will be randomized (i.e. participant will have a
      50% chance to be placed in either group) to be trained with VR or a mannequin. Participants
      then will be trained on airway injury management using their assigned training approach. One
      week later, all participants will be assessed on their airway injury management skills using
      a mannequin. Before and after their sessions, participants will also be asked to complete a
      questionnaire on their clinical decision-making. Participants who received VR training will
      also complete a questionnaire about their experience with the VR training.

      This study will help develop a new approach to airway management training which is cheaper
      and more easily available to medical trainees than mannequin training. This educational tool
      could lead to better treatment of airway trauma in future patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
masking description: An external assessor will score videos participants performing Airway Trauma Management using the Airway Injury Checklist on Core Decision Making Steps. The assessors will be blinded to intervention.
measure: Change in Traumatic Airway Injury Management Knowledge
time frame: up to 24 hours before and up to 24 hours after practice sessions
description: Knowledge acquisition of traumatic airway injury management as assessed by the written Key Features Decision Making Checklist, Change from baseline (pre-training) knowledge to after practice session knowledge (post-training).
measure: Application of Traumatic Airway Injury Management Knowledge
time frame: 7 days after practice session
description: Application of decision making concepts surrounding traumatic airway injury management as assessed by the Airway Injury Checklist of Core Decision Making Steps completed during participant performance of a simulated crisis assessment scenario.
measure: Number of Required Practice Sessions
time frame: During the 1 day practice session
description: Identify whether VR or mannequin-based simulation practice require fewer practice sessions to achieve learning objectives.
arm group label: VR-based Simulation (Intervention)
arm group type: Experimental
description: Students will receive training on traumatic airway management using VR-based simulation.
arm group label: Mannequin-based Simulation (Control)
arm group type: Other
description: Students will receive training on traumatic airway management using mannequin-based simulation.
intervention type: Other
intervention name: VR-based simulation
description: Participants will experience a novel interactive and immersive VR full size trauma bay with an adult patient and healthcare professionals. Immersed in the environment, learners undertake the decision-making steps in managing the medical care for a patient with an airway injury. Learners are first given the case scenario from which they form their own learning goals/plans. They then navigate through the scenario that will provide feedback depending on their actions in the form of either the patient's hemodynamic changes or prompts from healthcare avatars in the scenario. These feedback processes are built-in and designed to promote reflection and reorganization of the learner's decision-making strategies. As learning progresses, fewer prompts will be given. At the end of the scenario, evaluation algorithms pre-programmed into the VR-based simulation will be displayed.
arm group label: VR-based Simulation (Intervention)
intervention type: Other
intervention name: Mannequin-based simulation
description: Participants will experience a mannequin-based scenario practice which is the current gold standard in medical education. The trauma airway management scenario will match the VR environment and sequence of events.
arm group label: Mannequin-based Simulation (Control)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alam Fahad, MD, M.Sc
phone: 416-480-4864
phone ext: 4798
email: fahad.alam@sunnybrook.ca
last name: Lilia Kaustov, PhD
phone: 416-480-6100
phone ext: 89607
email: lilia.kaustov@sunnybrook.ca
facility: 
status: Recruiting
investigator: 
country: Canada
responsible party type: Sponsor
mesh term: Wounds and Injuries
sharing ipd: No