<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/NCT03800316</url>
  </required_header>
  <id_info>
    <org_study_id>18-005054</org_study_id>
    <nct_id>NCT03800316</nct_id>
  </id_info>
  <brief_title>Synchronous Video (Telemedicine) Consulation in the Prehospital Setting</brief_title>
  <official_title>Synchronous Video (Telemedicine) Consulation in the Prehospital Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      The study team aims to test connectivity metrics and follow patient outcomes using a new,&#xD;
      innovative synchronous video technology in the prehospital setting in three distinct areas:&#xD;
&#xD;
        1. - 911 Calls&#xD;
&#xD;
        2. - Pediatric Critical Care Transport&#xD;
&#xD;
      Currently, paramedics and pediatric transport teams seek advice from physicians using a&#xD;
      telephone. This project replaces the phone with video consultation where the physicians can&#xD;
      directly interact with patients, paramedics and transport teams when care advice is needed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 14, 2019</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</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>Video Consultations Completed</measure>
    <time_frame>1 year</time_frame>
    <description>Total number of video consultations completed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>1 year</time_frame>
    <description>Total number of subject deaths</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>1 year</time_frame>
    <description>Total number of hours subjects were admitted to the hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Emergency Room Length of Stay</measure>
    <time_frame>1 year</time_frame>
    <description>Total number of hours subjects were admitted to the emergency room</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Emergencies</condition>
  <condition>Prehospital</condition>
  <condition>Telemedicine</condition>
  <condition>Telehealth</condition>
  <arm_group>
    <arm_group_label>Synchronous Video Consultation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Testing the feasibility of a synchronous video consultation in the field prior to emergency department arrival.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Video Consultation</intervention_name>
    <description>Video consultation with emergency medicine physicians for patients that are critically ill prior to arrival in the ED</description>
    <arm_group_label>Synchronous Video Consultation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cardiac Arrest&#xD;
&#xD;
          -  Hemodynamically unstable trauma patients requiring resuscitation and airway management&#xD;
&#xD;
          -  Trauma patients with altered mentation requiring airway management&#xD;
&#xD;
          -  Acute stroke patients&#xD;
&#xD;
          -  Medical patients that refuse transport for medical evaluation Pediatric Intensive Care&#xD;
             Telemedicine Program&#xD;
&#xD;
          -  Complex clinical situations where paramedic teams need immediate management guidance&#xD;
&#xD;
          -  Critically ill pediatric patients requiring evaluation/stabilization for interfacility&#xD;
             transport&#xD;
&#xD;
          -  Pediatric patients requiring intervention for respiratory failure&#xD;
&#xD;
          -  Pediatric patients with ongoing seizures and/or neurological abnormalities&#xD;
&#xD;
          -  Hemodynamically unstable patients&#xD;
&#xD;
          -  Complex clinical situations requiring medical control guidance&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • All other patients not list above&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher S Russi</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>May 1, 2020</last_update_submitted>
  <last_update_submitted_qc>May 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Christopher S. Russi</investigator_full_name>
    <investigator_title>Prinipal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</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/NCT03800316
org study id: 18-005054
nct id: NCT03800316
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study team aims to test connectivity metrics and follow patient outcomes using a new,
      innovative synchronous video technology in the prehospital setting in three distinct areas:

        1. - 911 Calls

        2. - Pediatric Critical Care Transport

      Currently, paramedics and pediatric transport teams seek advice from physicians using a
      telephone. This project replaces the phone with video consultation where the physicians can
      directly interact with patients, paramedics and transport teams when care advice is needed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Video Consultations Completed
time frame: 1 year
description: Total number of video consultations completed
measure: Mortality
time frame: 1 year
description: Total number of subject deaths
measure: Hospital Length of Stay
time frame: 1 year
description: Total number of hours subjects were admitted to the hospital
measure: Emergency Room Length of Stay
time frame: 1 year
description: Total number of hours subjects were admitted to the emergency room
arm group label: Synchronous Video Consultation
arm group type: Experimental
description: Testing the feasibility of a synchronous video consultation in the field prior to emergency department arrival.
intervention type: Device
intervention name: Video Consultation
description: Video consultation with emergency medicine physicians for patients that are critically ill prior to arrival in the ED
arm group label: Synchronous Video Consultation
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Christopher S Russi
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Christopher S. Russi
investigator title: Prinipal Investigator
mesh term: Emergencies
sharing ipd: No