<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/NCT02974790</url>
  </required_header>
  <id_info>
    <org_study_id>I16035 (ECHOBEDSIDE)</org_study_id>
    <nct_id>NCT02974790</nct_id>
  </id_info>
  <brief_title>Diagnostic Performance of Echocardiography Performed by Emergency Physicians After a Basic Training</brief_title>
  <acronym>ECHOBEDSIDE</acronym>
  <official_title>Diagnostic Performance of Echocardiography Performed by Emergency Physicians After a Basic Training</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Limoges</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Tours</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Limoges</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      After a basic training to echocardiography, emergency physicians will have to answer simple&#xD;
      clinical questions about circulatory failure mechanisms. The objective of the study is to&#xD;
      assess the agreement between these answers and those of the expert physician in patients&#xD;
      admitted in the emergency department with a circulatory failure due to sepsis or not.&#xD;
      Emergency physicians will volunteer to take part in a basic training on echocardiography. The&#xD;
      training will include 4 hours of theory, 2 hours of interactive clinical cases and 6 hours of&#xD;
      tutored practice at patients' bedside (10 to 15 examinations). The objective of the practice&#xD;
      sessions will be to learn the technical grounds of transthoracic echocardiography (TTE), the&#xD;
      different views and to identify the anatomical structures. The second part of the study will&#xD;
      start after the training. Each eligible patient will be successively assessed by two&#xD;
      investigators: one emergency physician recently trained and the expert physician. The&#xD;
      echocardiography will be performed as soon as possible in the emergency department before or&#xD;
      after the initiation of treatment without delaying it. The order of hemodynamic assessments&#xD;
      will be random depending on the availability of the investigators; both assessments will&#xD;
      however be performed within 30 minutes. Each investigator will independently read the&#xD;
      echocardiography in real time at patients' bedside. They will then answer a limited list of&#xD;
      standardized questions using two-choice answers or predefined choices. Finally investigators&#xD;
      will choose a therapeutic proposition among a predefined list based on the answers. Only the&#xD;
      results of the echocardiography performed by the expert physician will be used in patient&#xD;
      management.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After a basic training to echocardiography, emergency physicians will have to answer simple&#xD;
      clinical questions about circulatory failure mechanisms. The objective of the study is to&#xD;
      assess the agreement between these answers and those of the expert physician in patients&#xD;
      admitted in the emergency department with a circulatory failure due to sepsis or not.&#xD;
      Emergency physicians will volunteer to take part in a basic training on echocardiography. The&#xD;
      training will include 4 hours of theory, 2 hours of interactive clinical cases and 6 hours of&#xD;
      tutored practice at patients' bedside (10 to 15 examinations). The objective of the practice&#xD;
      sessions will be to learn the technical grounds of transthoracic echocardiography (TTE), the&#xD;
      different views and to identify the anatomical structures. The second part of the study will&#xD;
      start after the training. Each eligible patient will be successively assessed by two&#xD;
      investigators: one emergency physician recently trained and the expert physician. The&#xD;
      echocardiography will be performed as soon as possible in the emergency department before or&#xD;
      after the initiation of treatment without delaying it. The order of hemodynamic assessments&#xD;
      will be random depending on the availability of the investigators; both assessments will&#xD;
      however be performed within 30 minutes. Each investigator will independently read the&#xD;
      echocardiography in real time at patients' bedside. They will then answer a limited list of&#xD;
      standardized questions using two-choice answers or predefined choices. Finally investigators&#xD;
      will choose a therapeutic proposition among a predefined list based on the answers. Only the&#xD;
      results of the echocardiography performed by the expert physician will be used in patient&#xD;
      management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Not enough patient&#xD;
  </why_stopped>
  <start_date type="Actual">January 2, 2017</start_date>
  <completion_date type="Actual">March 2, 2018</completion_date>
  <primary_completion_date type="Actual">January 2, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Agreement between emergency physician and referee physician echocardiography</measure>
    <time_frame>Day 1</time_frame>
    <description>Agreement between the measurements performed using two-dimensional imaging echocardiography by an emergency physician and the referring physician according to the following data :&#xD;
size of the left ventricle&#xD;
systolic function of the left ventricle&#xD;
size of the right ventricle&#xD;
dysfunction of the right ventricle&#xD;
size of the inferior vena cava pericardial effusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Agreement between emergency physicians and referring physician therapeutic propositions</measure>
    <time_frame>Day 1</time_frame>
    <description>Agreement between emergency physicians and referring physician therapeutic propositions according to the following choices:&#xD;
vascular filling define as a water volume of at least 500 mL&#xD;
vasopressor support&#xD;
positive inotropic therapy&#xD;
salt and water depletion</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">89</enrollment>
  <condition>Circulatory Failure</condition>
  <condition>Echocardiography</condition>
  <arm_group>
    <arm_group_label>Circulatory failure</arm_group_label>
    <description>Patients with a circulatory failure due to a sepsis or not</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Echocardiography</intervention_name>
    <description>Two-dimensional imaging echocardiography</description>
    <arm_group_label>Circulatory failure</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Hemodynamic assessment will target patients with circulatory failure and / or sepsis in&#xD;
        emergency unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients &gt; 18 years old&#xD;
&#xD;
          -  patients admitted in the Emergency Department of Limoges University Hospital&#xD;
&#xD;
          -  patients with circulatory failure defined as 1 or more of the following criteria :&#xD;
&#xD;
          -  clinical signs of tissue hypoperfusion&#xD;
&#xD;
          -  mottling&#xD;
&#xD;
          -  Encephalopathy&#xD;
&#xD;
          -  Oliguria &lt; 0.5 ml/kg/h&#xD;
&#xD;
          -  biological signs of hypoperfusion&#xD;
&#xD;
          -  Lactate &gt; 2 mmol/L&#xD;
&#xD;
          -  AND/OR Low blood pressure defined as a sBP &lt; 90 mmHg or mBP &lt; 65 mmHG or decrease of&#xD;
             sBP &gt; 40 mmHg compared with usual blood pressure&#xD;
&#xD;
          -  OR Patients with signs of sepsis recently defined as the following :&#xD;
&#xD;
          -  Suspicion of clinical infection&#xD;
&#xD;
          -  At least 2 of the 3 following items (i.e. SOFA &gt; 2 points with 1 point/item) :&#xD;
&#xD;
          -  Glasgow score &lt; 13&#xD;
&#xD;
          -  Respiratory rate &gt; 22 cycle/min&#xD;
&#xD;
          -  Systolic blood pressure &lt; 100 mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Moribund patients or with limited care&#xD;
&#xD;
          -  Patients under legal protection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Limoges University Hospital</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>March 27, 2018</last_update_submitted>
  <last_update_submitted_qc>March 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>echocardiography</keyword>
  <keyword>training</keyword>
  <keyword>emergency department</keyword>
  <keyword>circulatory failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Shock</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/NCT02974790
org study id: I16035 (ECHOBEDSIDE)
nct id: NCT02974790
lead sponsor: 
collaborator: 
has dmc: No
After a basic training to echocardiography, emergency physicians will have to answer simple
      clinical questions about circulatory failure mechanisms. The objective of the study is to
      assess the agreement between these answers and those of the expert physician in patients
      admitted in the emergency department with a circulatory failure due to sepsis or not.
      Emergency physicians will volunteer to take part in a basic training on echocardiography. The
      training will include 4 hours of theory, 2 hours of interactive clinical cases and 6 hours of
      tutored practice at patients' bedside (10 to 15 examinations). The objective of the practice
      sessions will be to learn the technical grounds of transthoracic echocardiography (TTE), the
      different views and to identify the anatomical structures. The second part of the study will
      start after the training. Each eligible patient will be successively assessed by two
      investigators: one emergency physician recently trained and the expert physician. The
      echocardiography will be performed as soon as possible in the emergency department before or
      after the initiation of treatment without delaying it. The order of hemodynamic assessments
      will be random depending on the availability of the investigators; both assessments will
      however be performed within 30 minutes. Each investigator will independently read the
      echocardiography in real time at patients' bedside. They will then answer a limited list of
      standardized questions using two-choice answers or predefined choices. Finally investigators
      will choose a therapeutic proposition among a predefined list based on the answers. Only the
      results of the echocardiography performed by the expert physician will be used in patient
      management.
After a basic training to echocardiography, emergency physicians will have to answer simple
      clinical questions about circulatory failure mechanisms. The objective of the study is to
      assess the agreement between these answers and those of the expert physician in patients
      admitted in the emergency department with a circulatory failure due to sepsis or not.
      Emergency physicians will volunteer to take part in a basic training on echocardiography. The
      training will include 4 hours of theory, 2 hours of interactive clinical cases and 6 hours of
      tutored practice at patients' bedside (10 to 15 examinations). The objective of the practice
      sessions will be to learn the technical grounds of transthoracic echocardiography (TTE), the
      different views and to identify the anatomical structures. The second part of the study will
      start after the training. Each eligible patient will be successively assessed by two
      investigators: one emergency physician recently trained and the expert physician. The
      echocardiography will be performed as soon as possible in the emergency department before or
      after the initiation of treatment without delaying it. The order of hemodynamic assessments
      will be random depending on the availability of the investigators; both assessments will
      however be performed within 30 minutes. Each investigator will independently read the
      echocardiography in real time at patients' bedside. They will then answer a limited list of
      standardized questions using two-choice answers or predefined choices. Finally investigators
      will choose a therapeutic proposition among a predefined list based on the answers. Only the
      results of the echocardiography performed by the expert physician will be used in patient
      management.
observational model: Cohort
time perspective: Prospective
measure: Agreement between emergency physician and referee physician echocardiography
time frame: Day 1
description: Agreement between the measurements performed using two-dimensional imaging echocardiography by an emergency physician and the referring physician according to the following data :
size of the left ventricle
systolic function of the left ventricle
size of the right ventricle
dysfunction of the right ventricle
size of the inferior vena cava pericardial effusion
measure: Agreement between emergency physicians and referring physician therapeutic propositions
time frame: Day 1
description: Agreement between emergency physicians and referring physician therapeutic propositions according to the following choices:
vascular filling define as a water volume of at least 500 mL
vasopressor support
positive inotropic therapy
salt and water depletion
arm group label: Circulatory failure
description: Patients with a circulatory failure due to a sepsis or not
intervention type: Procedure
intervention name: Echocardiography
description: Two-dimensional imaging echocardiography
arm group label: Circulatory failure
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Emergencies
mesh term: Shock
sharing ipd: No