<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/NCT02967809</url>
  </required_header>
  <id_info>
    <org_study_id>00010254 --- 2016 --- 122</org_study_id>
    <nct_id>NCT02967809</nct_id>
  </id_info>
  <brief_title>Usefulness of an Ultraportative Ultrasound Device in the Management of Intra Hospital Emergencies</brief_title>
  <official_title>Usefulness of an Ultraportative Ultrasound Device in the Management of Intra Hospital Emergencies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Nord</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Nord</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Estimate if the use of a portable cardiac echograph for intra-hospital Emergencie improves&#xD;
      the performances diagnose in the bed of patient in department of conventional medicine.&#xD;
&#xD;
      The concordance between the initial medical diagnosis (previous the utilsation of portable&#xD;
      echograph) and the final diagnosis (after portable echograph utisation) will be evaluated.&#xD;
      These evaluation will be performed after retrospective review of the medical files&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2016</start_date>
  <completion_date type="Actual">September 2019</completion_date>
  <primary_completion_date type="Actual">November 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Concordance between initial medecial diagnosis and final diagnosis</measure>
    <time_frame>1 day</time_frame>
    <description>Concordance between the initial medical diagnosis at the bedside in ward and the definitive diagnosis after retrospective review of the medical files between two groups : one with an ultraportative echograph (POCUS group) and a control (without ultraportative group). The percentage of adequate initiale diagnosis at the bedside.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">172</enrollment>
  <condition>Respiratory Failure</condition>
  <condition>Failure; Cardiac</condition>
  <arm_group>
    <arm_group_label>final diagnosis after portable echography</arm_group_label>
    <description>Experimental group: final diagnosis after portable cardiac echograph examination</description>
  </arm_group>
  <arm_group>
    <arm_group_label>final diagnosis without portable echography</arm_group_label>
    <description>Group control: Final diagnosis for patient ( same medical condition and history) hospitalized in units without portable cardiac echograph examination avaible</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>echography</intervention_name>
    <description>cardiac and pulmonary echography</description>
    <arm_group_label>final diagnosis after portable echography</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient suffering of respiratory or cardiac distress&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  respiratory or cardiac distress&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pulmonary or cardiac patient transplant morphologic abnormalities Patient in&#xD;
             rescucitation care unit&#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>Marc Leone, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>DAR Nord</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Departement anesthesie reanimation hopital nord</name>
      <address>
        <city>Marseille</city>
        <zip>13015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>April 22, 2020</last_update_submitted>
  <last_update_submitted_qc>April 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2020</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>Respiratory Insufficiency</mesh_term>
    <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/NCT02967809
org study id: 00010254 --- 2016 --- 122
nct id: NCT02967809
lead sponsor: 
has dmc: No
Estimate if the use of a portable cardiac echograph for intra-hospital Emergencie improves
      the performances diagnose in the bed of patient in department of conventional medicine.

      The concordance between the initial medical diagnosis (previous the utilsation of portable
      echograph) and the final diagnosis (after portable echograph utisation) will be evaluated.
      These evaluation will be performed after retrospective review of the medical files
observational model: Case-Control
time perspective: Prospective
measure: Concordance between initial medecial diagnosis and final diagnosis
time frame: 1 day
description: Concordance between the initial medical diagnosis at the bedside in ward and the definitive diagnosis after retrospective review of the medical files between two groups : one with an ultraportative echograph (POCUS group) and a control (without ultraportative group). The percentage of adequate initiale diagnosis at the bedside.
arm group label: final diagnosis after portable echography
description: Experimental group: final diagnosis after portable cardiac echograph examination
arm group label: final diagnosis without portable echography
description: Group control: Final diagnosis for patient ( same medical condition and history) hospitalized in units without portable cardiac echograph examination avaible
intervention type: Device
intervention name: echography
description: cardiac and pulmonary echography
arm group label: final diagnosis after portable echography
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc Leone, MD
role: Principal Investigator
affiliation: DAR Nord
facility: 
country: France
responsible party type: Sponsor
mesh term: Respiratory Insufficiency
mesh term: Emergencies
sharing ipd: No