<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/NCT03262532</url>
  </required_header>
  <id_info>
    <org_study_id>REB 15-9547</org_study_id>
    <nct_id>NCT03262532</nct_id>
  </id_info>
  <brief_title>Assessment of a Web-Based Simulation in Transesophageal Echocardiography (TEE) Views</brief_title>
  <acronym>Web-SimTEE</acronym>
  <official_title>Assessment of a Web-Based Simulation Module to Improve Performance in Obtaining Standard Transesophageal Echocardiography (TEE) Views</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Transesophageal echocardiography (TEE) is often used by anesthesiologists during cardiac&#xD;
      surgery, as a monitoring tool in non-cardiac surgery, and as a point of care diagnostic tool&#xD;
      in the intensive care unit (ICU). Furthermore, TEE is becoming a core skill in many&#xD;
      specialties to facilitate focused cardiovascular assessment in hemodynamically compromised&#xD;
      patients in various settings. Educators must determine how to best instruct current and&#xD;
      future trainees to achieve clinical competence in TEE within a time limited and constantly&#xD;
      expanding medical curriculum.&#xD;
&#xD;
      In this study the investigators will evaluate a new online TEE Simulation module as a&#xD;
      learning tool to accelerate and enhance traditional clinical teaching. This project will&#xD;
      evaluate a new online TEE Simulation module that replicates the actions required to adjust&#xD;
      TEE probe position and the ultrasound plane in relation to a 3D heart model.&#xD;
&#xD;
      The investigators hypothesize that experience with the online TEE simulation module will&#xD;
      improve the ability of trainees to independently perform TEE probe manipulations necessary to&#xD;
      obtain standard TEE views. The proposed study will answer this question by measuring the&#xD;
      performance of trainees in obtaining 10 of the 25 standard TEE views using the Vimedix&#xD;
      mannequin-based ultrasonography simulator following an hour of review of the online TEE&#xD;
      Simulation module.&#xD;
&#xD;
      The educational benefit of the Web-based TEE simulation module, will be evaluated by 20&#xD;
      novices randomly assigned to two groups, a control group of 10 subjects without exposure to&#xD;
      the Web-based simulation, and an experimental group of 10 subjects with exposure to the&#xD;
      Web-based simulation. Both groups will be assessed on their performance in attaining the 10&#xD;
      standard TEE views with the Vimedix simulator.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 13, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>TEE simulation model decreases time to select image acquisition in trainee participant vs. participants trained by reading material only</measure>
    <time_frame>2 week review 1 session for assessment (Control: time required to acquire 10 views, Intervention: I hour session with online simulator plus time required to acquire 10 views)</time_frame>
    <description>The metrics for acquiring each image will be recorded by the model, the primary measurement will be time in seconds per view acquired.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>TEE simulation model improves select image quality in trainee participants vs. participants trained by reading material only as assessed by a expert review panel of echo cardiographers</measure>
    <time_frame>2 week review 1 session for assessment- time required to acquire 10 views</time_frame>
    <description>Each image will be captured by the model and graded according to a 5 point scale.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Education</condition>
  <condition>Training</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <description>Learning TEE manipulation with a Web-based TEE simulation module</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Learning a TEE manipulation without the Web-based TEE simulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Web-base simulator</intervention_name>
    <description>Training manipulation of TEE using a Web-based simulator</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No web-base simulator</intervention_name>
    <description>Training manipulation of TEE with out a web-base simulator</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We will recruit residents and fellows during their training from the University of Toronto&#xD;
        postgraduate programs in anesthesia, cardiology and critical care. They will have some&#xD;
        knowledge of transthoracic echocardiography but no prior experience with TEE probe&#xD;
        manipulation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Residents or fellows in anesthesia, cardiology and critical care enrolled at the&#xD;
             Toronto General Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Residents or fellows in anesthesia, cardiology and critical care with prior experience&#xD;
             with TEE probe manipulation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Annette Vegas, MD</last_name>
    <phone>416-340-4800</phone>
    <phone_ext>5543</phone_ext>
    <email>annette.vegas@uhn.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>Toronto General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>March 30, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>February 16, 2018</last_update_submitted>
  <last_update_submitted_qc>February 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Interactive web-base simulation</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Publication</ipd_description>
  </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/NCT03262532
org study id: REB 15-9547
nct id: NCT03262532
lead sponsor: 
has dmc: No
Transesophageal echocardiography (TEE) is often used by anesthesiologists during cardiac
      surgery, as a monitoring tool in non-cardiac surgery, and as a point of care diagnostic tool
      in the intensive care unit (ICU). Furthermore, TEE is becoming a core skill in many
      specialties to facilitate focused cardiovascular assessment in hemodynamically compromised
      patients in various settings. Educators must determine how to best instruct current and
      future trainees to achieve clinical competence in TEE within a time limited and constantly
      expanding medical curriculum.

      In this study the investigators will evaluate a new online TEE Simulation module as a
      learning tool to accelerate and enhance traditional clinical teaching. This project will
      evaluate a new online TEE Simulation module that replicates the actions required to adjust
      TEE probe position and the ultrasound plane in relation to a 3D heart model.

      The investigators hypothesize that experience with the online TEE simulation module will
      improve the ability of trainees to independently perform TEE probe manipulations necessary to
      obtain standard TEE views. The proposed study will answer this question by measuring the
      performance of trainees in obtaining 10 of the 25 standard TEE views using the Vimedix
      mannequin-based ultrasonography simulator following an hour of review of the online TEE
      Simulation module.

      The educational benefit of the Web-based TEE simulation module, will be evaluated by 20
      novices randomly assigned to two groups, a control group of 10 subjects without exposure to
      the Web-based simulation, and an experimental group of 10 subjects with exposure to the
      Web-based simulation. Both groups will be assessed on their performance in attaining the 10
      standard TEE views with the Vimedix simulator.
observational model: Cohort
time perspective: Prospective
measure: TEE simulation model decreases time to select image acquisition in trainee participant vs. participants trained by reading material only
time frame: 2 week review 1 session for assessment (Control: time required to acquire 10 views, Intervention: I hour session with online simulator plus time required to acquire 10 views)
description: The metrics for acquiring each image will be recorded by the model, the primary measurement will be time in seconds per view acquired.
measure: TEE simulation model improves select image quality in trainee participants vs. participants trained by reading material only as assessed by a expert review panel of echo cardiographers
time frame: 2 week review 1 session for assessment- time required to acquire 10 views
description: Each image will be captured by the model and graded according to a 5 point scale.
arm group label: Experimental
description: Learning TEE manipulation with a Web-based TEE simulation module
arm group label: Control
description: Learning a TEE manipulation without the Web-based TEE simulation
intervention type: Other
intervention name: Web-base simulator
description: Training manipulation of TEE using a Web-based simulator
arm group label: Experimental
intervention type: Other
intervention name: No web-base simulator
description: Training manipulation of TEE with out a web-base simulator
arm group label: Control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Annette Vegas, MD
phone: 416-340-4800
phone ext: 5543
email: annette.vegas@uhn.ca
facility: 
status: Recruiting
country: Canada
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Publication