<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/NCT03811730</url>
  </required_header>
  <id_info>
    <org_study_id>TEE</org_study_id>
    <nct_id>NCT03811730</nct_id>
  </id_info>
  <brief_title>The Diagnosis and Treatment System of Transesophageal Echocardiography in ICU</brief_title>
  <official_title>The Diagnosis and Treatment System of Transesophageal Echocardiography in ICU</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kang Yan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>West China Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Transesophageal ultrasound offers imaging through the esophagus on the surface of the heart,&#xD;
      with good image quality and unique advantages. However, no studies to date have examined its&#xD;
      effect in critically ill patients in China.Therefore, the investigators aimed to compare the&#xD;
      efficacy and safety of TEE with TTE. the investigators will conducte a Multi-center,&#xD;
      prospective observational control study enrolling critically ill adult patients in several&#xD;
      ICU in China .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients in ICU were assessed for the need for TEE by trained researcher. Eligible patients&#xD;
      would be conducted tee examination by researcher A, TTE by the researcher B ,at the same&#xD;
      time, researcher C records the basic condition and clinical data of patientsand carried out&#xD;
      micro-enlargement test.The examination results are judged by A and B respectively and&#xD;
      provided to the physician of this patient, and A return visit to the physician wold be&#xD;
      conducted by researcher D to evaluate the acceptance of TTE and TEE results and judge the&#xD;
      clinical effects. The primary outcome is the clinical effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">August 31, 2023</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>Screening</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Conclusion of the adoption</measure>
    <time_frame>48 hours after completion of the examination</time_frame>
    <description>Researcher C conducted a questionnaire survey on attending physician to evaluate the effect</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse events</measure>
    <time_frame>completion of the examination</time_frame>
    <description>Adverse events associated with the examination，eg.1.Anesthetic allergy;2.Nausea, vomiting, choking cough or aspiration;3.Laryngeal edema and even asphyxiation;4.Severe arrhythmia;5.Esophageal perforation, bleeding, or local hematoma;6.Other accidental deaths, such as acute myocardial infarction, shock, haemorrhage and possibly even death;7.Other unpredictable contingencies or complications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Critically Ill</condition>
  <arm_group>
    <arm_group_label>TEE group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Eligible patients would be conducted TEE examination by researcher A,The examination results are judged by A and provided to the physician of this patient,</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TTE group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Eligible patients would be conducted TTE examination by researcher B,The examination results are judged by B and provided to the physician of this patient,</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Transesophageal echocardiography</intervention_name>
    <description>Eligible patients would be conducted both Transesophageal echocardiography and Transthoracic echocardiography to offer independent results</description>
    <arm_group_label>TEE group</arm_group_label>
    <arm_group_label>TTE group</arm_group_label>
    <other_name>Transthoracic echocardiography</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The quality of Transthoracic echocardiography is poor ( &gt;3 sections cannot be obtained&#xD;
             or the inner membrane is not clear)&#xD;
&#xD;
          2. The diagnosis of the etiology by Transthoracic ultrasonography is still unclear&#xD;
&#xD;
          3. The results of Transthoracic ultrasonography are inconsistent with clinical judgment&#xD;
             or cannot explain the existing signs.&#xD;
&#xD;
          4. No obvious improvement or even aggravation after thoracic examination and&#xD;
             corresponding treatment&#xD;
&#xD;
          5. Special conditions or clinical scenarios&#xD;
&#xD;
          6. Other clinicians think a TEE check is required.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. There is a tee test taboo and clinicians evaluate the risk over benefit&#xD;
&#xD;
          2. Did not sign an informed consent form&#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_contact>
    <last_name>Yi Li, PhD</last_name>
    <phone>(+86)13438168612</phone>
    <email>526563716@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Critical Care Medicine, Peking Union Medical College Hospital, Peking Union Medical College &amp; Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hua Zhao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital Central South University</name>
      <address>
        <city>Changsha</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Chenghuan Hu, PhD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The People's Hospital of Guangxi Zhuang Autonomous Region</name>
      <address>
        <city>Nanning</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Liwen Lv</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Hospital of China Medical University</name>
      <address>
        <city>Shengyang</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Xiaohan Yin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhongnan Hospital of Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Shuhan Cai, PhD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 10, 2019</study_first_submitted>
  <study_first_submitted_qc>January 18, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>July 8, 2021</last_update_submitted>
  <last_update_submitted_qc>July 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 9, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>West China Hospital</investigator_affiliation>
    <investigator_full_name>Kang Yan</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>transesophageal echocardiography</keyword>
  <keyword>intensive care unit</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</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/NCT03811730
org study id: TEE
nct id: NCT03811730
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Transesophageal ultrasound offers imaging through the esophagus on the surface of the heart,
      with good image quality and unique advantages. However, no studies to date have examined its
      effect in critically ill patients in China.Therefore, the investigators aimed to compare the
      efficacy and safety of TEE with TTE. the investigators will conducte a Multi-center,
      prospective observational control study enrolling critically ill adult patients in several
      ICU in China .
Patients in ICU were assessed for the need for TEE by trained researcher. Eligible patients
      would be conducted tee examination by researcher A, TTE by the researcher B ,at the same
      time, researcher C records the basic condition and clinical data of patientsand carried out
      micro-enlargement test.The examination results are judged by A and B respectively and
      provided to the physician of this patient, and A return visit to the physician wold be
      conducted by researcher D to evaluate the acceptance of TTE and TEE results and judge the
      clinical effects. The primary outcome is the clinical effects.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Single (Participant)
measure: Conclusion of the adoption
time frame: 48 hours after completion of the examination
description: Researcher C conducted a questionnaire survey on attending physician to evaluate the effect
measure: adverse events
time frame: completion of the examination
description: Adverse events associated with the examination，eg.1.Anesthetic allergy;2.Nausea, vomiting, choking cough or aspiration;3.Laryngeal edema and even asphyxiation;4.Severe arrhythmia;5.Esophageal perforation, bleeding, or local hematoma;6.Other accidental deaths, such as acute myocardial infarction, shock, haemorrhage and possibly even death;7.Other unpredictable contingencies or complications
arm group label: TEE group
arm group type: Experimental
description: Eligible patients would be conducted TEE examination by researcher A,The examination results are judged by A and provided to the physician of this patient,
arm group label: TTE group
arm group type: Active Comparator
description: Eligible patients would be conducted TTE examination by researcher B,The examination results are judged by B and provided to the physician of this patient,
intervention type: Diagnostic Test
intervention name: Transesophageal echocardiography
description: Eligible patients would be conducted both Transesophageal echocardiography and Transthoracic echocardiography to offer independent results
arm group label: TEE group
arm group label: TTE group
other name: Transthoracic echocardiography
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yi Li, PhD
phone: (+86)13438168612
email: 526563716@qq.com
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: West China Hospital
investigator full name: Kang Yan
investigator title: Director
mesh term: Critical Illness