<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/NCT02218983</url>
  </required_header>
  <id_info>
    <org_study_id>620651</org_study_id>
    <nct_id>NCT02218983</nct_id>
  </id_info>
  <brief_title>The Prognostic Value of Limited Transthoracic Echocardiogram (LTTE) During Trauma Resuscitation</brief_title>
  <official_title>The Prognostic Value of Limited Transthoracic Echocardiogram (LTTE) During Trauma Resuscitation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Riverside University Health System Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Riverside University Health System Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary caregiver thoracic ultrasound (U/S) is a skill which is growing in utility in&#xD;
      critical care. First introduced for volume assessment in nephrology and cardiology, it is now&#xD;
      being researched in emergency and critical care. Data is still evolving in its use in initial&#xD;
      trauma evaluation. Inferior vena cava (IVC) diameter correlates with outcome in trauma, but&#xD;
      utility of its measurement on U/S in the emergency department still has some controversy. In&#xD;
      trauma specifically, small studies suggests benefit to the use of U/S to predict volume&#xD;
      status, and most of these data are from one author. It is not known if this can be applied&#xD;
      more broadly. The prognostic value of findings on limited transthoracic echocardiogram (LTTE,&#xD;
      SonoSite Ultrasound) has been studied in several small studies, and only one small randomized&#xD;
      controlled trial has proven benefit to its use. Due to inter-rater reliability and the fact&#xD;
      that all reports on credentialing of thoracic ultrasound use in the trauma bay are from one&#xD;
      group, it is not known if it can be applied to all trauma populations.&#xD;
&#xD;
      Research question:&#xD;
&#xD;
      Does LTTE (SonoSite Ultrasound) predict mortality, emergency surgery, intensive care unit&#xD;
      (ICU) stay, hospital stay, time on ventilator, number of transfusions, or renal failure as&#xD;
      well as or better than other methods of organ perfusion?&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
        1. Use of LTTE is associated with improved outcomes (less organ failure, decreased hospital&#xD;
           and ICU stays, transfusions, and mortality).&#xD;
&#xD;
        2. LTTE predicts mortality, emergency surgery, ICU stay, hospital stay, time on ventilator,&#xD;
           number of and transfusions better than other methods of organ perfusion (tachycardia,&#xD;
           hypotension, lactate, lactate clearance, creatinine, base deficit).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>length of stay in the intensive care unit</measure>
    <time_frame>length of stay in the intensive care unit, not to exceed 30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>mortality (death)</measure>
    <time_frame>mortality (death) during hospital stay, not to exceed 30 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Patients Who Are in Shock and Intubated in the Trauma Bay (TB)</condition>
  <arm_group>
    <arm_group_label>Limited transthoracic echocardiogram (LTTE)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LTTE (SonoSite Ultrasound), which will be performed every 10 - 30 minutes, after each fluid challenge or transfusion, until two consecutive equivalent measurements are reached without fluid challenge or transfusion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>measurements on :blood pressure, heart rate, urine output, lactate, lactate clearance (after 6 hrs), base deficit, creatinine</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Limited Transthoracic Echocardiogram (LTTE, SonoSite Ultrasound)</intervention_name>
    <arm_group_label>Limited transthoracic echocardiogram (LTTE)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Usual care</intervention_name>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients arriving to trauma bay aged 18 or higher&#xD;
&#xD;
          -  Hypotensive (systolic blood pressure (SBP) &lt; 90 mmHg or mean arterial pressure (MAP) &lt;&#xD;
             65, on 2 measurements)&#xD;
&#xD;
          -  Respiratory failure (requiring mechanical ventilation)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to draw blood before transfusion or fluid challenge&#xD;
&#xD;
          -  Patient arrests within 10 minutes of arrival&#xD;
&#xD;
          -  Pregnant&#xD;
&#xD;
        Note: If inferior vena cava (IVC) not visible on ultrasound (U/S), pt will go to non-IVC&#xD;
        group.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aron Depew, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Riverside University Health System Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aron Depew, MD</last_name>
    <phone>951-486-5857</phone>
    <email>adepew@co.riverside.ca.us</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hayley S Lee, MPH</last_name>
    <phone>951-486-5857</phone>
    <email>haylee@co.riverside.ca.us</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Riverside County Regional Medical Center</name>
      <address>
        <city>Moreno Valley</city>
        <state>California</state>
        <zip>92555</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aron Depew, MD</last_name>
      <phone>951-486-5857</phone>
      <email>adepew@co.riverside.ca.us</email>
    </contact>
    <contact_backup>
      <last_name>Hayley Lee, MPH</last_name>
      <phone>951-486-5857</phone>
      <email>haylee@co.riverside.ca.us</email>
    </contact_backup>
    <investigator>
      <last_name>Aron Depew, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>April 14, 2017</last_update_submitted>
  <last_update_submitted_qc>April 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Riverside University Health System Medical Center</investigator_affiliation>
    <investigator_full_name>Aron Depew, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>trauma</keyword>
  <keyword>echo</keyword>
  <keyword>echocardiogram</keyword>
  <keyword>ultrasound</keyword>
  <keyword>inferior vena cava collapsibility</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/NCT02218983
org study id: 620651
nct id: NCT02218983
lead sponsor: 
has dmc: No
Primary caregiver thoracic ultrasound (U/S) is a skill which is growing in utility in
      critical care. First introduced for volume assessment in nephrology and cardiology, it is now
      being researched in emergency and critical care. Data is still evolving in its use in initial
      trauma evaluation. Inferior vena cava (IVC) diameter correlates with outcome in trauma, but
      utility of its measurement on U/S in the emergency department still has some controversy. In
      trauma specifically, small studies suggests benefit to the use of U/S to predict volume
      status, and most of these data are from one author. It is not known if this can be applied
      more broadly. The prognostic value of findings on limited transthoracic echocardiogram (LTTE,
      SonoSite Ultrasound) has been studied in several small studies, and only one small randomized
      controlled trial has proven benefit to its use. Due to inter-rater reliability and the fact
      that all reports on credentialing of thoracic ultrasound use in the trauma bay are from one
      group, it is not known if it can be applied to all trauma populations.

      Research question:

      Does LTTE (SonoSite Ultrasound) predict mortality, emergency surgery, intensive care unit
      (ICU) stay, hospital stay, time on ventilator, number of transfusions, or renal failure as
      well as or better than other methods of organ perfusion?

      Hypotheses:

        1. Use of LTTE is associated with improved outcomes (less organ failure, decreased hospital
           and ICU stays, transfusions, and mortality).

        2. LTTE predicts mortality, emergency surgery, ICU stay, hospital stay, time on ventilator,
           number of and transfusions better than other methods of organ perfusion (tachycardia,
           hypotension, lactate, lactate clearance, creatinine, base deficit).
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: length of stay in the intensive care unit
time frame: length of stay in the intensive care unit, not to exceed 30 days
measure: mortality (death)
time frame: mortality (death) during hospital stay, not to exceed 30 days
arm group label: Limited transthoracic echocardiogram (LTTE)
arm group type: Experimental
description: LTTE (SonoSite Ultrasound), which will be performed every 10 - 30 minutes, after each fluid challenge or transfusion, until two consecutive equivalent measurements are reached without fluid challenge or transfusion
arm group label: Usual care
arm group type: Active Comparator
description: measurements on :blood pressure, heart rate, urine output, lactate, lactate clearance (after 6 hrs), base deficit, creatinine
intervention type: Device
intervention name: Limited Transthoracic Echocardiogram (LTTE, SonoSite Ultrasound)
arm group label: Limited transthoracic echocardiogram (LTTE)
intervention type: Other
intervention name: Usual care
arm group label: Usual care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Aron Depew, MD
role: Principal Investigator
affiliation: Riverside University Health System Medical Center
last name: Aron Depew, MD
phone: 951-486-5857
email: adepew@co.riverside.ca.us
last name: Hayley S Lee, MPH
phone: 951-486-5857
email: haylee@co.riverside.ca.us
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Riverside University Health System Medical Center
investigator full name: Aron Depew, MD
investigator title: Principal Investigator
mesh term: Wounds and Injuries