<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/NCT03041350</url>
  </required_header>
  <id_info>
    <org_study_id>SWALS</org_study_id>
    <nct_id>NCT03041350</nct_id>
  </id_info>
  <brief_title>Smartphone Video-assisted Advanced Life Support of Patients With Out-of-hospital Cardiac Arrest by EMS Under Physician Direction</brief_title>
  <acronym>SWALS</acronym>
  <official_title>Smartphone Video-assisted Advanced Life Support of Patients With Out-of-hospital Cardiac Arrest by EMS Under Physician Direction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Public Safety and Security</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ajou University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Saint Vincent's Hospital, Korea</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Soonchunhyang University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <brief_summary>
    <textblock>
      Direct medical control using video conferencing capabilities of smartphones has never been&#xD;
      conducted in out-of-hospital cardiac arrest patients. This study was conducted to investigate&#xD;
      its feasibility and treatment effectiveness in out-of-hospital cardiac arrest (OHCA) patients&#xD;
      using a real-time smartphone video call.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      If cardiac arrest is suspected, the EMS personnel contacted the medical director before&#xD;
      arriving at the scene. Upon the arrival at the scene of the two activated paramedic teams,&#xD;
      they rapidly switch to ALS under teamwork-based BLS and video medical control. Using this&#xD;
      video medical control, high-quality CPR, cardiac arrest rhythm confirmation, defibrillation,&#xD;
      proper drug administration instructions, advanced airway insertion, etc. are performed. The&#xD;
      medical director then decides on patient transfer if the asystole and pulseless electrical&#xD;
      activity findings are persistent even after more than 20-minutes of ALS. After initiating the&#xD;
      transfer, the medical director contacts the hospital where the patient is to be transferred&#xD;
      to after completing the video medical control. The medical director provides an explanation&#xD;
      of the treatment to the caregiver via video. After returning to the fire station, the EMS&#xD;
      personnel who had completed the patient's transfer the enters the information by hand on the&#xD;
      separate form, takes a picture of the document, and uploads it to SNS within 24 hours.&#xD;
      Through this information shared via SNS, the research staff the provides a direct feedback to&#xD;
      the EMS personnel, and further discussion performed within the SNS. All the incident cases of&#xD;
      OHCA during the before and during interventional periods were registered using an EMS run&#xD;
      sheet for basic ambulance operation information, the EMS cardiac arrest registry for the&#xD;
      Utstein factors, and the OHCA registry for the hospital care and survival outcomes. The EMS&#xD;
      run sheet and EMS cardiac arrest registry were collected by the EMS providers. The medical&#xD;
      records for hospital care and outcomes were abstracted by the trained reviewer for this study&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>survival rate</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>favorable neurologic outcome rate</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>rate of prehospital return of systemic circulation(ROSC)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>feasibility</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Confidence scores of 10 items for determining CPR performances which is measured on a 10 point likert scale by physicians</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Out-of-Hospital Cardiac Arrest</condition>
  <arm_group>
    <arm_group_label>Smartphone video-assisted ALS &amp; Conventional CPR</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In study period, using this video medical control, high-quality CPR, cardiac arrest rhythm confirmation, defibrillation, proper drug administration instructions, advanced airway insertion, etc. are performed. The medical director then decides on patient transfer if the asystole and pulseless electrical activity findings are persistent even after more than 20-minutes of ALS.&#xD;
The conventional CPR is Basic life support only in the automatic external defibrillator (AED) mode 5-10 minutes at the scene, are not allowed to stop resuscitation at the scene unless there is a return of spontaneous circulation (ROSC) or pre-hospital cardiac arrest patient has already been transported to a hospital.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Smartphone video-assisted ALS(advanced life support)</intervention_name>
    <description>As an preparation for this study, personnel training in mock advanced life support (ALS) simulation including the smartphone video call methodology was conducted. The smartphones were not separately purchased or produced; commercially available smartphones already owned by the emergency medical service (EMS) personnel and medical directors were used. To facilitate the smartphone video call between the medical director and the EMS personnel and to prevent the caregivers or others nearby from hearing the conversation, Bluetooth earphone sets were used. Data were collected using the cardiopulmonary resuscitation (CPR) recording form uploaded in SNS which consisted of EMS personnel and medical directors, and the quality of CPR was evaluated</description>
    <arm_group_label>Smartphone video-assisted ALS &amp; Conventional CPR</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all EMS-treated OHCA patients older than 18 years transported to the hospital unless&#xD;
             otherwise diagnosed with trauma, poisoning, asphyxia, hanging, or any other&#xD;
             non-disease-origin factors.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with do-not-resuscitate (DNR) orders and with obvious signs of irreversible&#xD;
             death, including rigor mortis and corruption&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gi Woon Kim, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Emergency Medicine, Soonchunhyang University Bucheon Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emergency medical service system of Suwon city</name>
      <address>
        <city>Suwon city</city>
        <state>Gyeonggi-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>January 31, 2017</last_update_submitted>
  <last_update_submitted_qc>January 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Yu Jin Kim, MD</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Emergency Medical Services</keyword>
  <keyword>Smartphone</keyword>
  <keyword>Survival</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
    <mesh_term>Out-of-Hospital Cardiac Arrest</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/NCT03041350
org study id: SWALS
nct id: NCT03041350
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
Direct medical control using video conferencing capabilities of smartphones has never been
      conducted in out-of-hospital cardiac arrest patients. This study was conducted to investigate
      its feasibility and treatment effectiveness in out-of-hospital cardiac arrest (OHCA) patients
      using a real-time smartphone video call.
If cardiac arrest is suspected, the EMS personnel contacted the medical director before
      arriving at the scene. Upon the arrival at the scene of the two activated paramedic teams,
      they rapidly switch to ALS under teamwork-based BLS and video medical control. Using this
      video medical control, high-quality CPR, cardiac arrest rhythm confirmation, defibrillation,
      proper drug administration instructions, advanced airway insertion, etc. are performed. The
      medical director then decides on patient transfer if the asystole and pulseless electrical
      activity findings are persistent even after more than 20-minutes of ALS. After initiating the
      transfer, the medical director contacts the hospital where the patient is to be transferred
      to after completing the video medical control. The medical director provides an explanation
      of the treatment to the caregiver via video. After returning to the fire station, the EMS
      personnel who had completed the patient's transfer the enters the information by hand on the
      separate form, takes a picture of the document, and uploads it to SNS within 24 hours.
      Through this information shared via SNS, the research staff the provides a direct feedback to
      the EMS personnel, and further discussion performed within the SNS. All the incident cases of
      OHCA during the before and during interventional periods were registered using an EMS run
      sheet for basic ambulance operation information, the EMS cardiac arrest registry for the
      Utstein factors, and the OHCA registry for the hospital care and survival outcomes. The EMS
      run sheet and EMS cardiac arrest registry were collected by the EMS providers. The medical
      records for hospital care and outcomes were abstracted by the trained reviewer for this study
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: survival rate
time frame: 1 year
measure: favorable neurologic outcome rate
time frame: 1 year
measure: rate of prehospital return of systemic circulation(ROSC)
time frame: through study completion, an average of 1 year
measure: feasibility
time frame: through study completion, an average of 1 year
description: Confidence scores of 10 items for determining CPR performances which is measured on a 10 point likert scale by physicians
arm group label: Smartphone video-assisted ALS & Conventional CPR
arm group type: Experimental
description: In study period, using this video medical control, high-quality CPR, cardiac arrest rhythm confirmation, defibrillation, proper drug administration instructions, advanced airway insertion, etc. are performed. The medical director then decides on patient transfer if the asystole and pulseless electrical activity findings are persistent even after more than 20-minutes of ALS.
The conventional CPR is Basic life support only in the automatic external defibrillator (AED) mode 5-10 minutes at the scene, are not allowed to stop resuscitation at the scene unless there is a return of spontaneous circulation (ROSC) or pre-hospital cardiac arrest patient has already been transported to a hospital.
intervention type: Other
intervention name: Smartphone video-assisted ALS(advanced life support)
description: As an preparation for this study, personnel training in mock advanced life support (ALS) simulation including the smartphone video call methodology was conducted. The smartphones were not separately purchased or produced; commercially available smartphones already owned by the emergency medical service (EMS) personnel and medical directors were used. To facilitate the smartphone video call between the medical director and the EMS personnel and to prevent the caregivers or others nearby from hearing the conversation, Bluetooth earphone sets were used. Data were collected using the cardiopulmonary resuscitation (CPR) recording form uploaded in SNS which consisted of EMS personnel and medical directors, and the quality of CPR was evaluated
arm group label: Smartphone video-assisted ALS & Conventional CPR
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Gi Woon Kim, M.D., Ph.D.
role: Principal Investigator
affiliation: Department of Emergency Medicine, Soonchunhyang University Bucheon Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Yu Jin Kim, MD
investigator title: Assistant Professor
mesh term: Heart Arrest
mesh term: Out-of-Hospital Cardiac Arrest