<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/NCT02198885</url>
  </required_header>
  <id_info>
    <org_study_id>FAST-01</org_study_id>
    <secondary_id>Bio# 14-109</secondary_id>
    <nct_id>NCT02198885</nct_id>
  </id_info>
  <brief_title>Comparing Use of a Prehospital Ultrasound System and Standard Prehospital Care in Thoracoabdominal Trauma</brief_title>
  <acronym>FAST-01</acronym>
  <official_title>Post-marketing, Single-center, Controlled, Open-Label, Feasibility Study Comparing Use of a Prehospital Ultrasound System and Standard Prehospital Care in Patients With Thoracoabdominal Trauma.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Saskatchewan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Saskatoon Health Region</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>M.D. Ambulance Care Ltd.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Saskatchewan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The NanoMaxx Ultrasound System (SonoSite) in connection with the RP-Xpress (InTouch&#xD;
      Technologies) provides a means of transmitting ultrasound images, video, and audio to a&#xD;
      remote location in real-time. It has been envisioned that this system be used to diagnose&#xD;
      trauma patients with suspected pleural effusion, hemothorax, pneumothorax, or abdominal&#xD;
      blockage during prehospital care; under the guidance of in-hospital physicians, paramedics&#xD;
      would perform an Focused Assessment with Sonography for Trauma (FAST) examination while&#xD;
      trauma patients are transported to hospital via ambulance. The investigators hypothesize that&#xD;
      in-hospital physicians interpreting ultrasound images obtained by paramedics during trauma&#xD;
      patients' transportation to hospital will reduce time to diagnosis; thus, preparations by&#xD;
      emergency physicians, surgeons, and operating room teams to receive critically injured&#xD;
      patients may begin earlier, reducing time to intervention during a critical period in patient&#xD;
      care. Data will also be collected regarding quality of images obtained in-ambulance and the&#xD;
      interaction between paramedics and physicians using the remote-presence system.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time to diagnosis</measure>
    <time_frame>Within 24 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to intervention</measure>
    <time_frame>Within 24 hours</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Audio quality scores on the visual analog scale</measure>
    <time_frame>Same day</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Video quality scores on the visual analog scale</measure>
    <time_frame>Same day</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Thoracoabdominal Trauma</condition>
  <condition>Focused Assessment With Sonography for Trauma (FAST)</condition>
  <condition>NanoMaxx Ultrasound System (SonoSite)</condition>
  <condition>RP-Xpress (InTouch Technologies)</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>This group receives the standard prehospital care en route to hospital, and they do not receive the FAST ultrasound en route.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FAST</arm_group_label>
    <description>This group receives the FAST ultrasound en route to hospital.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients, presenting with blunt or penetrating trauma to the thorax or abdomen, that&#xD;
        are being transported by MD Ambulance to Royal University Hospital where the hospital trip&#xD;
        is expected to take longer than 10 minutes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for FAST cohort:&#xD;
&#xD;
          -  Patient is 18 years of age or older&#xD;
&#xD;
          -  Patient presenting with blunt or penetrating trauma to the thorax or abdomen&#xD;
&#xD;
          -  Patient transported by MD Ambulance to Royal University Hospital&#xD;
&#xD;
          -  Patient being transported by a paramedic who has received training in the above&#xD;
             ultrasound system and who has with them a NanoMaxx Ultrasound System (SonoSite) to be&#xD;
             used in connection with the RP-Xpress (InTouch Technologies)&#xD;
&#xD;
          -  Patient will take longer than 10 minutes to transport to hospital&#xD;
&#xD;
          -  Patient's care will not be compromised in completing a FAST exam - opinion of&#xD;
             paramedic&#xD;
&#xD;
          -  Patient's care will not be compromised in completing a FAST exam - opinion of ER&#xD;
             physician&#xD;
&#xD;
        Inclusion Criteria for Controls:&#xD;
&#xD;
          -  Patient is 18 years of age or older&#xD;
&#xD;
          -  Patient presenting with blunt or penetrating trauma to the thorax or abdomen&#xD;
&#xD;
          -  Patient transported by MD Ambulance to Royal University Hospital&#xD;
&#xD;
          -  Patient will take longer than 10 minutes to transport to hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under the age of 18&#xD;
&#xD;
          -  Patients whose care would be compromised if other procedures of higher priority (as&#xD;
             determined by paramedics and/or remotely-present physicians) were not be able to be&#xD;
             executed due to time involved in completing a FAST exam&#xD;
&#xD;
          -  Patients who are not being transported to Royal University Hospital&#xD;
&#xD;
          -  Patients whose expected transport time from scene to hospital is less than 10 minutes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ivar Mendez</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Saskatchewan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Royal University Hospital</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 0W8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>November 1, 2017</last_update_submitted>
  <last_update_submitted_qc>November 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Saskatchewan</investigator_affiliation>
    <investigator_full_name>Ivar Mendez</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>FAST</keyword>
  <keyword>Thoracoabdominal Trauma</keyword>
  <keyword>Prehospital care</keyword>
  <keyword>ultrasound</keyword>
  <keyword>NanoMaxx Ultrasound</keyword>
  <keyword>RP-Xpress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</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/NCT02198885
org study id: FAST-01
secondary id: Bio# 14-109
nct id: NCT02198885
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The NanoMaxx Ultrasound System (SonoSite) in connection with the RP-Xpress (InTouch
      Technologies) provides a means of transmitting ultrasound images, video, and audio to a
      remote location in real-time. It has been envisioned that this system be used to diagnose
      trauma patients with suspected pleural effusion, hemothorax, pneumothorax, or abdominal
      blockage during prehospital care; under the guidance of in-hospital physicians, paramedics
      would perform an Focused Assessment with Sonography for Trauma (FAST) examination while
      trauma patients are transported to hospital via ambulance. The investigators hypothesize that
      in-hospital physicians interpreting ultrasound images obtained by paramedics during trauma
      patients' transportation to hospital will reduce time to diagnosis; thus, preparations by
      emergency physicians, surgeons, and operating room teams to receive critically injured
      patients may begin earlier, reducing time to intervention during a critical period in patient
      care. Data will also be collected regarding quality of images obtained in-ambulance and the
      interaction between paramedics and physicians using the remote-presence system.
observational model: Case-Only
time perspective: Prospective
measure: Time to diagnosis
time frame: Within 24 hours
measure: Time to intervention
time frame: Within 24 hours
measure: Audio quality scores on the visual analog scale
time frame: Same day
measure: Video quality scores on the visual analog scale
time frame: Same day
arm group label: Control
description: This group receives the standard prehospital care en route to hospital, and they do not receive the FAST ultrasound en route.
arm group label: FAST
description: This group receives the FAST ultrasound en route to hospital.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ivar Mendez
role: Principal Investigator
affiliation: University of Saskatchewan
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Saskatchewan
investigator full name: Ivar Mendez
investigator title: M.D.
mesh term: Wounds and Injuries