<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/NCT03295669</url>
  </required_header>
  <id_info>
    <org_study_id>ELLOUZE 2016</org_study_id>
    <nct_id>NCT03295669</nct_id>
  </id_info>
  <brief_title>Continuous Monitoring of Right Ventricular Function, Based on the Correlation Between the C-X Segment of the Central Venous Pressure Curve, and the Echocardiographic Evaluation of Right Ventricular Systolic Function</brief_title>
  <acronym>CourbePVC</acronym>
  <official_title>Continuous Monitoring of Right Ventricular Function, Based on the Correlation Between the C-X Segment of the Central Venous Pressure Curve, and the Echocardiographic Evaluation of Right Ventricular Systolic Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire Dijon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire Dijon</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>
      Close analysis of right ventricular function is still not done by all clinicians, even though&#xD;
      it is indispensable; notably in cardiovascular ICUs.&#xD;
&#xD;
      Right ventricular dysfunction is responsible for increased morbidity and marks a turning&#xD;
      point in the patient's prognosis.&#xD;
&#xD;
      It is difficult to analyse, and is principally assessed using echocardiography and by&#xD;
      measuring the peak of the S' wave with pulsed Doppler and by measuring the tricuspid annular&#xD;
      plane systolic excursion (TAPSE) in the TM mode. New studies have shown the interest of using&#xD;
      2D strain as a marker of systolic and diastolic function of the right ventricle. Finally, the&#xD;
      use of 3D ultrasound seems to be more reliable than cardiac MRI for fine analysis of the&#xD;
      right ventricle, even though it is rarely used in routine practice.&#xD;
&#xD;
      Study of the right ventricle using ultrasonography alone requires experienced and available&#xD;
      operators for closely repeated evaluations making it possible to detect right ventricle&#xD;
      dysfunction quickly.&#xD;
&#xD;
      US monitoring of left and right heart function is done systematically and repeatedly during&#xD;
      post-operative care following heart surgery. This US evaluation could be optimized by finding&#xD;
      a way to monitor the right ventricle continuously.&#xD;
&#xD;
      From a physiological point of view, we know about the tight relationship between the aspect&#xD;
      of the central venous pressure curve and more precisely the C-X segment (tricuspid bulging&#xD;
      into the atrium and start of contraction of the right ventricle) and right ventricular&#xD;
      function. We wish to analyse this segment, combined with a US evaluation, and to look for a&#xD;
      possible correlation so as to allow continuous, easy-to-interpret monitoring of right&#xD;
      ventricular systolic function.&#xD;
&#xD;
      This will be facilitated by the systematic presence of a central venous catheter in every&#xD;
      patient undergoing heart surgery, thus allowing central venous pressure to be monitored.&#xD;
&#xD;
      To this end, we wish to collect different data from patients in the cardiovascular ICU,&#xD;
      especially the central venous pressure curve, the ventilatory pressure curve and settings of&#xD;
      the respirator, and to carry out an echography evaluation of each patient.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2016</start_date>
  <completion_date type="Actual">November 2, 2017</completion_date>
  <primary_completion_date type="Actual">November 2, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measure the peak of the S' wave</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure the tricuspid annular plane systolic excursion (TAPSE)</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Calculate strain in the right ventricle</measure>
    <time_frame>At baseline</time_frame>
  </primary_outcome>
  <enrollment type="Actual">250</enrollment>
  <condition>Heart Surgery</condition>
  <condition>Ultrasonography Right Ventricle Systolic Function</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to a cardiovascular ICU following heart surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted to the cardiovascular ICU&#xD;
&#xD;
          -  Patients with spontaneous breathing&#xD;
&#xD;
          -  With a central venous catheter placed in the internal jugular vein and for whom the&#xD;
             central venous pressure curve is exploitable&#xD;
&#xD;
          -  With a US window allowing a 4-chamber view making it possible to calculate the right&#xD;
             ventricle ejection fraction (Peak of the S' wave, of the TAPSE, Strain of the right&#xD;
             ventricle)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-echogenic patients or those without an exploitable US window&#xD;
&#xD;
          -  Patients without a central venous catheter in the internal jugular vein&#xD;
&#xD;
          -  Patients with an unexploitable central venous pressure curve&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Chu Dijon Bourogne</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 28, 2023</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>Systolic Murmurs</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/NCT03295669
org study id: ELLOUZE 2016
nct id: NCT03295669
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Close analysis of right ventricular function is still not done by all clinicians, even though
      it is indispensable; notably in cardiovascular ICUs.

      Right ventricular dysfunction is responsible for increased morbidity and marks a turning
      point in the patient's prognosis.

      It is difficult to analyse, and is principally assessed using echocardiography and by
      measuring the peak of the S' wave with pulsed Doppler and by measuring the tricuspid annular
      plane systolic excursion (TAPSE) in the TM mode. New studies have shown the interest of using
      2D strain as a marker of systolic and diastolic function of the right ventricle. Finally, the
      use of 3D ultrasound seems to be more reliable than cardiac MRI for fine analysis of the
      right ventricle, even though it is rarely used in routine practice.

      Study of the right ventricle using ultrasonography alone requires experienced and available
      operators for closely repeated evaluations making it possible to detect right ventricle
      dysfunction quickly.

      US monitoring of left and right heart function is done systematically and repeatedly during
      post-operative care following heart surgery. This US evaluation could be optimized by finding
      a way to monitor the right ventricle continuously.

      From a physiological point of view, we know about the tight relationship between the aspect
      of the central venous pressure curve and more precisely the C-X segment (tricuspid bulging
      into the atrium and start of contraction of the right ventricle) and right ventricular
      function. We wish to analyse this segment, combined with a US evaluation, and to look for a
      possible correlation so as to allow continuous, easy-to-interpret monitoring of right
      ventricular systolic function.

      This will be facilitated by the systematic presence of a central venous catheter in every
      patient undergoing heart surgery, thus allowing central venous pressure to be monitored.

      To this end, we wish to collect different data from patients in the cardiovascular ICU,
      especially the central venous pressure curve, the ventilatory pressure curve and settings of
      the respirator, and to carry out an echography evaluation of each patient.
observational model: Other
time perspective: Prospective
measure: Measure the peak of the S' wave
time frame: At baseline
measure: Measure the tricuspid annular plane systolic excursion (TAPSE)
time frame: At baseline
measure: Calculate strain in the right ventricle
time frame: At baseline
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Systolic Murmurs