<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/NCT04488627</url>
  </required_header>
  <id_info>
    <org_study_id>284/33</org_study_id>
    <nct_id>NCT04488627</nct_id>
  </id_info>
  <brief_title>Reliability of Ultrasound Examination of the Inferior Caval Vein</brief_title>
  <official_title>Reliability of Ultrasound Examination of the Inferior Caval Vein From Different Views in Critically Ill Patients on Artificial Lung Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emergency Medical Service of the Central Bohemian Region, Czech Republic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Masaryk Hospital Usti nad Labem</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Emergency Medical Service of the Central Bohemian Region, Czech Republic</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>
      The purpose of this study is to compare validity of examination and measurement of inferior&#xD;
      caval vein from different views in critically ill patients on mechanical ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A maximal and minimal diameter of inferior caval vein will be measured by transthoracic&#xD;
      echocardiography in critically ill patients on mechanical ventilation hospitalised in the&#xD;
      intensive care unit from four different views:&#xD;
&#xD;
        1. Subcostal view on the inferior caval vein in the long axis,&#xD;
&#xD;
        2. subcostal view on the inferior caval vein in the short axis,&#xD;
&#xD;
        3. right lateral view on the inferior caval vein in the long axis,&#xD;
&#xD;
        4. right lateral view on the inferior caval vein in the short axis.&#xD;
&#xD;
      Comparison between the results of measurements in the subcostal view in the long axis and&#xD;
      other views will be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 27, 2020</start_date>
  <completion_date type="Anticipated">July 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2021</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>Correlation between maximal and minimal diameter of the inferior caval vein from subcostal and right lateral view</measure>
    <time_frame>During the intervention</time_frame>
    <description>Inferior caval vein measurements are key parameters for assessment of preload and fluid responsiveness</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Transthoracic Echocardiography</condition>
  <arm_group>
    <arm_group_label>Critically ill patients</arm_group_label>
    <description>Critically ill patients hospitalised in the intensive care unit indicated to echocardiographic examination.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Conventional transthoracic echocardiographic examination at the intensive care unit.</intervention_name>
    <description>Conventional transthoracic echocardiographic examination at the intensive care unit targeted to inferior caval vein examination from different views.</description>
    <arm_group_label>Critically ill patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult intensive care unit patients on mechanical ventilation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inpatients&#xD;
&#xD;
          -  Patients on mechanical ventilation indicated for transthoracic echocardiographic&#xD;
             examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Insufficient imaging quality&#xD;
&#xD;
          -  Refusal of echocardiographic examination by patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Roman Skulec, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Masaryk Hospital Usti nad Labem</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Roman Skulec, MD, PhD</last_name>
    <phone>00420777577497</phone>
    <email>skulec@email.cz</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Barbora Pakostova, MD</last_name>
    <phone>00420720172670</phone>
    <email>Barbora.Pakostova@kzcr.eu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Masaryk Hospital Usti nad Labem</name>
      <address>
        <city>Usti nad Labem</city>
        <zip>40113</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roman Skulec, MD, PhD</last_name>
      <phone>00420777577497</phone>
      <email>skulec@email.cz</email>
    </contact>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>August 18, 2020</last_update_submitted>
  <last_update_submitted_qc>August 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Masaryk Hospital Usti nad Labem</investigator_affiliation>
    <investigator_full_name>Roman Skulec</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <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/NCT04488627
org study id: 284/33
nct id: NCT04488627
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare validity of examination and measurement of inferior
      caval vein from different views in critically ill patients on mechanical ventilation.
A maximal and minimal diameter of inferior caval vein will be measured by transthoracic
      echocardiography in critically ill patients on mechanical ventilation hospitalised in the
      intensive care unit from four different views:

        1. Subcostal view on the inferior caval vein in the long axis,

        2. subcostal view on the inferior caval vein in the short axis,

        3. right lateral view on the inferior caval vein in the long axis,

        4. right lateral view on the inferior caval vein in the short axis.

      Comparison between the results of measurements in the subcostal view in the long axis and
      other views will be performed.
observational model: Case-Only
time perspective: Prospective
measure: Correlation between maximal and minimal diameter of the inferior caval vein from subcostal and right lateral view
time frame: During the intervention
description: Inferior caval vein measurements are key parameters for assessment of preload and fluid responsiveness
arm group label: Critically ill patients
description: Critically ill patients hospitalised in the intensive care unit indicated to echocardiographic examination.
intervention type: Diagnostic Test
intervention name: Conventional transthoracic echocardiographic examination at the intensive care unit.
description: Conventional transthoracic echocardiographic examination at the intensive care unit targeted to inferior caval vein examination from different views.
arm group label: Critically ill patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Roman Skulec, MD, PhD
role: Principal Investigator
affiliation: Masaryk Hospital Usti nad Labem
last name: Roman Skulec, MD, PhD
phone: 00420777577497
email: skulec@email.cz
last name: Barbora Pakostova, MD
phone: 00420720172670
email: Barbora.Pakostova@kzcr.eu
facility: 
status: Recruiting
contact: 
country: Czechia
responsible party type: Principal Investigator
investigator affiliation: Masaryk Hospital Usti nad Labem
investigator full name: Roman Skulec
investigator title: Principal investigator
sharing ipd: No