<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/NCT02991521</url>
  </required_header>
  <id_info>
    <org_study_id>1606-30</org_study_id>
    <nct_id>NCT02991521</nct_id>
  </id_info>
  <brief_title>A Study to Improve the FAST Ultrasound Exam</brief_title>
  <official_title>Can we be FASTeR? A Multicenter Study Utilizing Right Sided Roll to Improve Sensitivity of the FAST Examination</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Guthrie Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Guthrie Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study aims to improve the standard exam called Focused Assessment with&#xD;
      Sonography in Trauma (FAST). The FAST exam is an ultrasound test used to identify an&#xD;
      abdominal bleed. The study will see if having patients roll on their right side improves the&#xD;
      FAST exam. Making the FAST exam better can help trauma doctors save the lives of patients&#xD;
      with bleeding.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">March 2023</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects screening positive for blood around the abdominal organs (hemoperitoneum) after trauma, as assessed by focused assessment with sonography for trauma (FAST), a rapid bedside ultrasound examination.</measure>
    <time_frame>24 hours</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Hemoperitoneum</condition>
  <arm_group>
    <arm_group_label>FAST examination after Right sided roll (FASTeR)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects will have a standard FAST exam, and will then be rolled onto their right side and the FAST exam will be repeated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fast exam</intervention_name>
    <description>Positional change before Fast exam</description>
    <arm_group_label>FAST examination after Right sided roll (FASTeR)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All trauma patients who present as a Trauma Activation with clinical history or&#xD;
             physical signs of blunt abdominal trauma.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant females&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Patients with prohibitive right sided chest trauma&#xD;
&#xD;
          -  Patients in extremis undergoing salvage maneuvers (chest compressions or emergent&#xD;
             surgical intervention) which prevents performance of an ultrasound examination&#xD;
&#xD;
          -  Patient who leave against medical advice or are otherwise removed from the medical&#xD;
             system before their work up has been completed&#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>Danielle Pigneri, MD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <overall_contact>
    <last_name>Danielle Pigneri, MD</last_name>
    <phone>(570)887-4882</phone>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Vicky Hickey</last_name>
    <phone>(570)887-4882</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Robert Packer Hospital</name>
      <address>
        <city>Sayre</city>
        <state>Pennsylvania</state>
        <zip>18840</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>The Guthrie Clinic</name>
      <address>
        <city>Sayre</city>
        <state>Pennsylvania</state>
        <zip>18840</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>March 14, 2022</last_update_submitted>
  <last_update_submitted_qc>March 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemoperitoneum</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 24, 2023</submitted>
  </pending_results>
  <!-- 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/NCT02991521
org study id: 1606-30
nct id: NCT02991521
lead sponsor: 
has dmc: No
This research study aims to improve the standard exam called Focused Assessment with
      Sonography in Trauma (FAST). The FAST exam is an ultrasound test used to identify an
      abdominal bleed. The study will see if having patients roll on their right side improves the
      FAST exam. Making the FAST exam better can help trauma doctors save the lives of patients
      with bleeding.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of subjects screening positive for blood around the abdominal organs (hemoperitoneum) after trauma, as assessed by focused assessment with sonography for trauma (FAST), a rapid bedside ultrasound examination.
time frame: 24 hours
arm group label: FAST examination after Right sided roll (FASTeR)
arm group type: Experimental
description: Subjects will have a standard FAST exam, and will then be rolled onto their right side and the FAST exam will be repeated.
intervention type: Procedure
intervention name: Fast exam
description: Positional change before Fast exam
arm group label: FAST examination after Right sided roll (FASTeR)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Danielle Pigneri, MD
role: Principal Investigator
last name: Danielle Pigneri, MD
phone: (570)887-4882
last name: Vicky Hickey
phone: (570)887-4882
facility: 
status: Recruiting
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Hemoperitoneum
sharing ipd: No
submitted: March 24, 2023