<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/NCT04478045</url>
  </required_header>
  <id_info>
    <org_study_id>202005121RINB</org_study_id>
    <nct_id>NCT04478045</nct_id>
  </id_info>
  <brief_title>The Application of Point-of-care Ultrasonography in Differential Diagnosis of Shock in Emergency and Critical Care</brief_title>
  <official_title>The Application of Point-of-care Ultrasonography in Differential Diagnosis of Shock in Emergency and Critical Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      For the emergency physicians and critical care specialists, how to quickly recognize shock&#xD;
      from diverse clinical features and immediately treat shock patients to prevent progression to&#xD;
      irreversible organ dysfunction from initially reversible shock condition are important issues&#xD;
      and challenges. In recent years, ultrasonography had been extensively used in clinical&#xD;
      practice recently, and well-trained medical staffs can quickly and easily apply ultrasound to&#xD;
      evaluate, examine, diagnose, and even treat the patients. The clinical application of&#xD;
      point-of-care ultrasound can help the first-line physicians rapidly evaluate and diagnose the&#xD;
      main symptoms and signs of the patients at bedside, and further initially stabilize and&#xD;
      appropriately treat the patients subsequently. The aim of this program is to prospectively&#xD;
      collection of the findings of point-of-care ultrasonography in shock patients at emergency&#xD;
      room in NTUH. The clinical manifestations, and followed up the examinations, treatments, and&#xD;
      prognosis will also be collected. The effect of bedside ultrasound on differential diagnosis&#xD;
      and treatment of shock patients will be analyzed. The results of the current study can&#xD;
      provide the base for further clinical trials and set up of shock team.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Shock is defined as cellular and tissue hypoxia due to either reduced oxygen delivery,&#xD;
      increased oxygen consumption, inadequate oxygen utilization, or a combination of these&#xD;
      processes. According to the etiology about how it causes a decrease in blood flow to the&#xD;
      cells and tissue, there are four types of shock naming cardiogenic shock, hypovolemic shock,&#xD;
      obstructive shock, and distributive shock, respectively. The evaluation and management of&#xD;
      shock patients is an extremely difficult challenge for the emergency physicians and critical&#xD;
      care specialists. How to diagnose, classify, stabilize, and treat the shock patients quickly&#xD;
      and in time are the arduous tasks. For the emergency physicians and critical care&#xD;
      specialists, how to quickly recognize shock from diverse clinical features and immediately&#xD;
      treat shock patients to prevent progression to irreversible organ dysfunction from initially&#xD;
      reversible shock condition are important issues and challenges. In recent years, ultrasound&#xD;
      instruments have gradually developed with higher radiographic quality and lower cost.&#xD;
      Ultrasonography had been extensively used in clinical practice recently, and well-trained&#xD;
      medical staffs can quickly and easily apply ultrasound to evaluate, examine, diagnose, and&#xD;
      even treat the patients. The clinical application of point-of-care ultrasound can help the&#xD;
      firstline physicians rapidly evaluate and diagnose the main symptoms and signs of the&#xD;
      patients at bedside, and further initially stabilize and appropriately treat the patients&#xD;
      subsequently. The aim of this program is to prospectively collection of the findings of&#xD;
      point-of-care ultrasonography in shock patients at emergency room in NTUH. The clinical&#xD;
      manifestations, and followed up the examinations, treatments, and prognosis will also be&#xD;
      collected. The effect of bedside ultrasound on differential diagnosis and treatment of shock&#xD;
      patients will be analyzed. The results of the current study can provide the base for further&#xD;
      clinical trials and set up of shock team.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">July 31, 2022</completion_date>
  <primary_completion_date type="Actual">July 31, 2022</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>The correlation between application of bedside ultrasound and differential diagnosis in shock patients</measure>
    <time_frame>6 month</time_frame>
    <description>The effect of bedside ultrasound on differential diagnosis and treatment of shock patients.</description>
  </primary_outcome>
  <enrollment type="Actual">278</enrollment>
  <condition>Shock</condition>
  <condition>Ultrasonography</condition>
  <condition>Differential Diagnosis</condition>
  <condition>Emergencies</condition>
  <condition>Critical Care</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The adult, non-traumatic, non-DNR shock patients in the emergency room at NTUH are enrolled&#xD;
        to our study. The point-of-care ultrasound in shock patients is performed by well-trained&#xD;
        medical staffs.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        The shock patients in the emergency room at NTUH with one of the following conditions:&#xD;
&#xD;
          1. A clinician evaluated patients were with insufficient or improper tissue&#xD;
&#xD;
          2. Patients' systolic blood pressure &lt; 90mmHg or mean arterial pressure &lt; 65mmHg&#xD;
&#xD;
          3. Patients' laboratory data showed lactic acid &gt; 2.2 mmol/L&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt; 20 years&#xD;
&#xD;
          2. Pregnancy&#xD;
&#xD;
          3. Traumatic patients&#xD;
&#xD;
          4. Patients with DNR(Do Not Resuscitate) status&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Min-Shan Tsai, PhD</last_name>
    <role>Study Director</role>
    <affiliation>National Taiwan University Medical College and Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>July 15, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>August 16, 2022</last_update_submitted>
  <last_update_submitted_qc>August 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Shock</keyword>
  <keyword>Ultrasonography</keyword>
  <keyword>Differential diagnosis</keyword>
  <keyword>Emergency care</keyword>
  <keyword>Critical care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Disease</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Shock</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/NCT04478045
org study id: 202005121RINB
nct id: NCT04478045
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
For the emergency physicians and critical care specialists, how to quickly recognize shock
      from diverse clinical features and immediately treat shock patients to prevent progression to
      irreversible organ dysfunction from initially reversible shock condition are important issues
      and challenges. In recent years, ultrasonography had been extensively used in clinical
      practice recently, and well-trained medical staffs can quickly and easily apply ultrasound to
      evaluate, examine, diagnose, and even treat the patients. The clinical application of
      point-of-care ultrasound can help the first-line physicians rapidly evaluate and diagnose the
      main symptoms and signs of the patients at bedside, and further initially stabilize and
      appropriately treat the patients subsequently. The aim of this program is to prospectively
      collection of the findings of point-of-care ultrasonography in shock patients at emergency
      room in NTUH. The clinical manifestations, and followed up the examinations, treatments, and
      prognosis will also be collected. The effect of bedside ultrasound on differential diagnosis
      and treatment of shock patients will be analyzed. The results of the current study can
      provide the base for further clinical trials and set up of shock team.
Shock is defined as cellular and tissue hypoxia due to either reduced oxygen delivery,
      increased oxygen consumption, inadequate oxygen utilization, or a combination of these
      processes. According to the etiology about how it causes a decrease in blood flow to the
      cells and tissue, there are four types of shock naming cardiogenic shock, hypovolemic shock,
      obstructive shock, and distributive shock, respectively. The evaluation and management of
      shock patients is an extremely difficult challenge for the emergency physicians and critical
      care specialists. How to diagnose, classify, stabilize, and treat the shock patients quickly
      and in time are the arduous tasks. For the emergency physicians and critical care
      specialists, how to quickly recognize shock from diverse clinical features and immediately
      treat shock patients to prevent progression to irreversible organ dysfunction from initially
      reversible shock condition are important issues and challenges. In recent years, ultrasound
      instruments have gradually developed with higher radiographic quality and lower cost.
      Ultrasonography had been extensively used in clinical practice recently, and well-trained
      medical staffs can quickly and easily apply ultrasound to evaluate, examine, diagnose, and
      even treat the patients. The clinical application of point-of-care ultrasound can help the
      firstline physicians rapidly evaluate and diagnose the main symptoms and signs of the
      patients at bedside, and further initially stabilize and appropriately treat the patients
      subsequently. The aim of this program is to prospectively collection of the findings of
      point-of-care ultrasonography in shock patients at emergency room in NTUH. The clinical
      manifestations, and followed up the examinations, treatments, and prognosis will also be
      collected. The effect of bedside ultrasound on differential diagnosis and treatment of shock
      patients will be analyzed. The results of the current study can provide the base for further
      clinical trials and set up of shock team.
observational model: Case-Only
time perspective: Prospective
measure: The correlation between application of bedside ultrasound and differential diagnosis in shock patients
time frame: 6 month
description: The effect of bedside ultrasound on differential diagnosis and treatment of shock patients.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Min-Shan Tsai, PhD
role: Study Director
affiliation: National Taiwan University Medical College and Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Disease
mesh term: Emergencies
mesh term: Shock