<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/NCT04435275</url>
  </required_header>
  <id_info>
    <org_study_id>20-5399</org_study_id>
    <nct_id>NCT04435275</nct_id>
  </id_info>
  <brief_title>Virtual Assistant for COVID-19 PPE</brief_title>
  <official_title>Development of an Automated and Scalable Virtual Assistant to Aid in PPE Adherence and Clinical Protocols for Healthcare Worker Safety</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>Yes</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>
      The COVID virus is acquired through droplet and micro droplet transmission. Although&#xD;
      healthcare workers must adhere to strict up-to-date clinical procedures to minimize exposure&#xD;
      to the virus and avoid contamination, the assumption that everyone can precisely remember&#xD;
      every step is improbable as many of these procedures are quite complex and involve multiple&#xD;
      steps in stressful situations. Further the use of a trained safety officer to ensure&#xD;
      adherence is not always feasible due to the ever growing demand of healthcare providers.&#xD;
      Investigators propose to utilize the Amazon Alexa device and Alexa Skills application to&#xD;
      develop a voice enabled virtual assistant to guide healthcare professionals through the exact&#xD;
      steps of clinical procedures including the donning and doffing of PPE, intubation and&#xD;
      extubation procedures.&#xD;
&#xD;
      Methods A total of 10 staff anesthesiologists will be recruited to participate in phase 1 of&#xD;
      the study to evaluate the utility and functionality of this VA device.&#xD;
&#xD;
      A total of 40 healthcare professionals will be recruited to participate in phase 2 of the&#xD;
      study. Anesthesia providers (staff and fellows), anesthesia assistants, respiratory&#xD;
      assistants and operating room nurses will be randomized to receive instructional guidance by&#xD;
      the VA on one test occasion and a human coach on another occasion. During this phase of the&#xD;
      study, the effectiveness of this VA prototype will be compared with a trained human safety&#xD;
      officer / coach in its ability to provide instructional guidance for 4 safety and clinical&#xD;
      procedures: 1) proper donning of personal protective equipment (PPE); 2) doffing of PPE; 3)&#xD;
      intubation (putting in a breathing tube) and 4) extubation (taking out a breathing tube).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2, 2021</start_date>
  <completion_date type="Anticipated">May 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2021</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>Crossover Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>performance of healthcare workers</measure>
    <time_frame>0- 30mins during donning</time_frame>
    <description>Errors occurred during donning of PPE measured by procedure checklist</description>
  </primary_outcome>
  <primary_outcome>
    <measure>performance of healthcare workers</measure>
    <time_frame>0- 30mins during doffing</time_frame>
    <description>Errors occurred during doffing of PPE measured by procedure checklist</description>
  </primary_outcome>
  <primary_outcome>
    <measure>performance of healthcare workers</measure>
    <time_frame>0- 30mins during intubation</time_frame>
    <description>Errors occurred during intubation measured by procedure checklist</description>
  </primary_outcome>
  <primary_outcome>
    <measure>performance of healthcare workers</measure>
    <time_frame>0- 30mins during extubation</time_frame>
    <description>Errors occurred during extubation measured by procedure checklist</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Donning PPE using VA then doffing PPE using HC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study subjects will receive VA guidance for donning first, then guidance from a human coach (HC) for doffing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Donning PPE using HC then doffing PPE using VA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study subjects will receive HC guidance for donning first, then VA guidance for doffing.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intubation using VA then extubation using HC;</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study subjects will receive VA guidance for the intubation first , then HC guidance for extubation procedure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intubation using HC then extubation using VA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study subjects will receive HC guidance for the intubation first , then VA guidance for extubation procedure</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Virtual Assistant first, then Human Coach</intervention_name>
    <description>Instructions to aid healthcare worker adherence to proper PPE and intubation and extubation procedure is given by a VA (e-coach) in place of a safety officer (a human coach).</description>
    <arm_group_label>Donning PPE using VA then doffing PPE using HC</arm_group_label>
    <arm_group_label>Intubation using VA then extubation using HC;</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Human Coach first, then Virtual Assistant</intervention_name>
    <description>instructions to aid healthcare worker adherence to proper PPE and intubation and extubation procedure is given by a safety officer (a human coach).</description>
    <arm_group_label>Donning PPE using HC then doffing PPE using VA</arm_group_label>
    <arm_group_label>Intubation using HC then extubation using VA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Only anesthesia attending staff are allowed in the phase 1 study.&#xD;
&#xD;
          -  Any working anesthesia staff and fellow, anesthesia assistant, respiratory assistant&#xD;
             and operating room nurse are qualified to take part in phase 2 of this study. However,&#xD;
             only anesthesia staff and fellows and anesthesia assistants will participate in the&#xD;
             part that involves intubation and extubation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Unwillingness to enter the study for phase 1 or phase 2.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rongyu ( Cindy) Jin</last_name>
    <phone>416-603-5800</phone>
    <phone_ext>2016</phone_ext>
    <email>rongyu.jin@uhn.ca</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Health Network</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>ON M5T 2S8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rongyu Jin</last_name>
      <email>rongyu.jin@uhn.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>January 7, 2021</last_update_submitted>
  <last_update_submitted_qc>January 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PPE adherence</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- 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/NCT04435275
org study id: 20-5399
nct id: NCT04435275
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The COVID virus is acquired through droplet and micro droplet transmission. Although
      healthcare workers must adhere to strict up-to-date clinical procedures to minimize exposure
      to the virus and avoid contamination, the assumption that everyone can precisely remember
      every step is improbable as many of these procedures are quite complex and involve multiple
      steps in stressful situations. Further the use of a trained safety officer to ensure
      adherence is not always feasible due to the ever growing demand of healthcare providers.
      Investigators propose to utilize the Amazon Alexa device and Alexa Skills application to
      develop a voice enabled virtual assistant to guide healthcare professionals through the exact
      steps of clinical procedures including the donning and doffing of PPE, intubation and
      extubation procedures.

      Methods A total of 10 staff anesthesiologists will be recruited to participate in phase 1 of
      the study to evaluate the utility and functionality of this VA device.

      A total of 40 healthcare professionals will be recruited to participate in phase 2 of the
      study. Anesthesia providers (staff and fellows), anesthesia assistants, respiratory
      assistants and operating room nurses will be randomized to receive instructional guidance by
      the VA on one test occasion and a human coach on another occasion. During this phase of the
      study, the effectiveness of this VA prototype will be compared with a trained human safety
      officer / coach in its ability to provide instructional guidance for 4 safety and clinical
      procedures: 1) proper donning of personal protective equipment (PPE); 2) doffing of PPE; 3)
      intubation (putting in a breathing tube) and 4) extubation (taking out a breathing tube).
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: None (Open Label)
measure: performance of healthcare workers
time frame: 0- 30mins during donning
description: Errors occurred during donning of PPE measured by procedure checklist
measure: performance of healthcare workers
time frame: 0- 30mins during doffing
description: Errors occurred during doffing of PPE measured by procedure checklist
measure: performance of healthcare workers
time frame: 0- 30mins during intubation
description: Errors occurred during intubation measured by procedure checklist
measure: performance of healthcare workers
time frame: 0- 30mins during extubation
description: Errors occurred during extubation measured by procedure checklist
arm group label: Donning PPE using VA then doffing PPE using HC
arm group type: Active Comparator
description: Study subjects will receive VA guidance for donning first, then guidance from a human coach (HC) for doffing.
arm group label: Donning PPE using HC then doffing PPE using VA
arm group type: Active Comparator
description: Study subjects will receive HC guidance for donning first, then VA guidance for doffing.
arm group label: Intubation using VA then extubation using HC;
arm group type: Active Comparator
description: Study subjects will receive VA guidance for the intubation first , then HC guidance for extubation procedure
arm group label: Intubation using HC then extubation using VA
arm group type: Active Comparator
description: Study subjects will receive HC guidance for the intubation first , then VA guidance for extubation procedure
intervention type: Other
intervention name: Virtual Assistant first, then Human Coach
description: Instructions to aid healthcare worker adherence to proper PPE and intubation and extubation procedure is given by a VA (e-coach) in place of a safety officer (a human coach).
arm group label: Donning PPE using VA then doffing PPE using HC
arm group label: Intubation using VA then extubation using HC;
intervention type: Other
intervention name: Human Coach first, then Virtual Assistant
description: instructions to aid healthcare worker adherence to proper PPE and intubation and extubation procedure is given by a safety officer (a human coach).
arm group label: Donning PPE using HC then doffing PPE using VA
arm group label: Intubation using HC then extubation using VA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Rongyu ( Cindy) Jin
phone: 416-603-5800
phone ext: 2016
email: rongyu.jin@uhn.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Sponsor
mesh term: COVID-19