<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/NCT04494152</url>
  </required_header>
  <id_info>
    <org_study_id>02/2020</org_study_id>
    <nct_id>NCT04494152</nct_id>
  </id_info>
  <brief_title>Reliability of Echocardiography From Subcostal View</brief_title>
  <official_title>Reliability of Echocardiographic Assessment of Cardiac Dimensions and Function From Subcostal View</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 assess reliability of echocardiographic assessment of&#xD;
      ventricular dimensions and function from subcostal view.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Assessment of the function and dimensions of the right and left ventricles is a key part of&#xD;
      Point-of-Care ultrasound in critically ill patients. According to the recent guidelines, this&#xD;
      evaluation is performed from apical and parasternal views. However, these views may not be&#xD;
      clearly visible in the clinical setting of critical illness and subcostal view is often&#xD;
      preferred for its higher feasibility. Before clinical adoption, it is necessary to assess&#xD;
      whether the isolated examination from subcostal view is reliable enough in the detection of&#xD;
      the impairment of systolic function and the size of both ventricles and the investigators&#xD;
      decided to evaluate this issue.&#xD;
&#xD;
      Transverse and longitudinal dimensions and function of both ventricles will be measured&#xD;
      calculated by transthoracic echocardiography in critically ill patients in the intensive care&#xD;
      unit from parasternal and apical views following the recent guidelines. Systolic function of&#xD;
      the left ventricle will be expressed by the left ventricular ejection fraction (calculated by&#xD;
      biplane method of disc summation) and by the fraction shortening. Systolic function of the&#xD;
      right ventricle will be assessed by the tricuspid annular plane systolic excursion,&#xD;
      fractional area change, tricuspid lateral annular systolic velocity, and right ventricular&#xD;
      index of myocardial performance. From subcostal view, transverse dimensions of both&#xD;
      ventricles and novel parameters of systolic function (subcostal tricuspid annular plane&#xD;
      systolic excursion, right ventricular subcostal fraction shortening, right ventricular&#xD;
      modified subcostal fraction shortening, left ventricular subcostal fraction shortening and&#xD;
      left ventricular modified fraction shortening) will be measured.&#xD;
&#xD;
      Then, the reliability of parameters measured in subcostal view will be tested by comparison&#xD;
      with conventional parameters taken from apical and parasternal view by correlation analysis&#xD;
      and diagnostic test evaluation. The most reliable thresholds of parameters from subcostal&#xD;
      view will be calculated by receiver operating characteristic analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 20, 2020</start_date>
  <completion_date type="Anticipated">October 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 28, 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>Reliability of left ventricular subcostal fractional shortening and left ventricular modified subcostal fractional shortening in determining the global left ventricular systolic function in critically ill patients.</measure>
    <time_frame>During the procedure</time_frame>
    <description>Left ventricular subcostal fractional shortening and left ventricular modified subcostal fractional shortening are new potential echocardiographic parameters of left ventricular systolic function measurable from subcostal view.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reliability of right ventricular subcostal fractional shortening and right ventricular modified subcostal fractional shortening in determining the global right ventricular systolic function in critically ill patients.</measure>
    <time_frame>During the procedure</time_frame>
    <description>Right ventricular subcostal fractional shortening and right ventricular modified subcostal fractional shortening are new potential echocardiographic parameters of right ventricular systolic function measurable from subcostal view.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Reliability of echocardiographic parameters evaluating the structure of the left ventricle measured in a subcostal view in critically ill patients.</measure>
    <time_frame>During the procedure</time_frame>
    <description>Quantification of the left ventricular structure (size and mass) is an important part of echocardiographic examination in critically ill patients. However, the reliability of these parameters measured in the subcostal projection has not been defined.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reliability of echocardiographic parameters evaluating the size of the right ventricle measured in a subcostal view in critically ill patients.</measure>
    <time_frame>During the procedure</time_frame>
    <description>Quantification of the right ventricular size is an important part of echocardiographic examination in critically ill patients. However, its reliability when measured in the subcostal projection has not been defined.</description>
  </secondary_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>Adult critically ill patients hospitalised in the intensive care unit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Transthoracic echocardiography</intervention_name>
    <description>Standard Point-of-Care echocardiographic examination in the intensive care unit.</description>
    <arm_group_label>Critically ill patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult critically ill patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inpatients&#xD;
&#xD;
          -  All patients hospitalised in intensive care unit indicated for transthoracic&#xD;
             echocardiography examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Insufficient imaging quality of transthoracic echocardiography&#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>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </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>
  <reference>
    <citation>Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.</citation>
    <PMID>25559473</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>August 20, 2020</last_update_submitted>
  <last_update_submitted_qc>August 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emergency Medical Service of the Central Bohemian Region, Czech Republic</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/NCT04494152
org study id: 02/2020
nct id: NCT04494152
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to assess reliability of echocardiographic assessment of
      ventricular dimensions and function from subcostal view.
Assessment of the function and dimensions of the right and left ventricles is a key part of
      Point-of-Care ultrasound in critically ill patients. According to the recent guidelines, this
      evaluation is performed from apical and parasternal views. However, these views may not be
      clearly visible in the clinical setting of critical illness and subcostal view is often
      preferred for its higher feasibility. Before clinical adoption, it is necessary to assess
      whether the isolated examination from subcostal view is reliable enough in the detection of
      the impairment of systolic function and the size of both ventricles and the investigators
      decided to evaluate this issue.

      Transverse and longitudinal dimensions and function of both ventricles will be measured
      calculated by transthoracic echocardiography in critically ill patients in the intensive care
      unit from parasternal and apical views following the recent guidelines. Systolic function of
      the left ventricle will be expressed by the left ventricular ejection fraction (calculated by
      biplane method of disc summation) and by the fraction shortening. Systolic function of the
      right ventricle will be assessed by the tricuspid annular plane systolic excursion,
      fractional area change, tricuspid lateral annular systolic velocity, and right ventricular
      index of myocardial performance. From subcostal view, transverse dimensions of both
      ventricles and novel parameters of systolic function (subcostal tricuspid annular plane
      systolic excursion, right ventricular subcostal fraction shortening, right ventricular
      modified subcostal fraction shortening, left ventricular subcostal fraction shortening and
      left ventricular modified fraction shortening) will be measured.

      Then, the reliability of parameters measured in subcostal view will be tested by comparison
      with conventional parameters taken from apical and parasternal view by correlation analysis
      and diagnostic test evaluation. The most reliable thresholds of parameters from subcostal
      view will be calculated by receiver operating characteristic analysis.
observational model: Case-Only
time perspective: Prospective
measure: Reliability of left ventricular subcostal fractional shortening and left ventricular modified subcostal fractional shortening in determining the global left ventricular systolic function in critically ill patients.
time frame: During the procedure
description: Left ventricular subcostal fractional shortening and left ventricular modified subcostal fractional shortening are new potential echocardiographic parameters of left ventricular systolic function measurable from subcostal view.
measure: Reliability of right ventricular subcostal fractional shortening and right ventricular modified subcostal fractional shortening in determining the global right ventricular systolic function in critically ill patients.
time frame: During the procedure
description: Right ventricular subcostal fractional shortening and right ventricular modified subcostal fractional shortening are new potential echocardiographic parameters of right ventricular systolic function measurable from subcostal view.
measure: Reliability of echocardiographic parameters evaluating the structure of the left ventricle measured in a subcostal view in critically ill patients.
time frame: During the procedure
description: Quantification of the left ventricular structure (size and mass) is an important part of echocardiographic examination in critically ill patients. However, the reliability of these parameters measured in the subcostal projection has not been defined.
measure: Reliability of echocardiographic parameters evaluating the size of the right ventricle measured in a subcostal view in critically ill patients.
time frame: During the procedure
description: Quantification of the right ventricular size is an important part of echocardiographic examination in critically ill patients. However, its reliability when measured in the subcostal projection has not been defined.
arm group label: Critically ill patients
description: Adult critically ill patients hospitalised in the intensive care unit.
intervention type: Diagnostic Test
intervention name: Transthoracic echocardiography
description: Standard Point-of-Care echocardiographic examination in the intensive care unit.
arm group label: Critically ill patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
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
citation: Lang RM, Badano LP, Mor-Avi V, Afilalo J, Armstrong A, Ernande L, Flachskampf FA, Foster E, Goldstein SA, Kuznetsova T, Lancellotti P, Muraru D, Picard MH, Rietzschel ER, Rudski L, Spencer KT, Tsang W, Voigt JU. Recommendations for cardiac chamber quantification by echocardiography in adults: an update from the American Society of Echocardiography and the European Association of Cardiovascular Imaging. J Am Soc Echocardiogr. 2015 Jan;28(1):1-39.e14. doi: 10.1016/j.echo.2014.10.003.
PMID: 25559473
responsible party type: Principal Investigator
investigator affiliation: Emergency Medical Service of the Central Bohemian Region, Czech Republic
investigator full name: Roman Skulec
investigator title: Principal investigator
sharing ipd: No