<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/NCT03270319</url>
  </required_header>
  <id_info>
    <org_study_id>16032016</org_study_id>
    <nct_id>NCT03270319</nct_id>
  </id_info>
  <brief_title>Evaluation of Three Dimensional Echocardiography in Critical Care Medicine</brief_title>
  <acronym>3DICU</acronym>
  <official_title>Evaluation of Three Dimensional Echocardiography in Critical Care Medicine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</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>
      Comparison of volumetric measurements obtained by three dimensional echocardiography with&#xD;
      measurements obtained by thermodilution using a pulmonary artery catheter in the intensive&#xD;
      care unit.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective, observational study evaluating three dimensional echocardiography for measuring&#xD;
      hemodynamic variables versus the current gold standard (pulmonary artery catheter).&#xD;
&#xD;
      Critically ill patients with a severly compromised circulation due to a shock state with an&#xD;
      advanced hemodynamic monitoring in place and the need for echocardiographic evaluation will&#xD;
      be included.&#xD;
&#xD;
      While performing an echocardiography study stroke volume measurements using the bolus method&#xD;
      for thermodilution will concomittantly be measured.&#xD;
&#xD;
      In case of insufficient image quality we are planning to use SonoVue echo contrast. Once the&#xD;
      image quality has improved we will repeat the stroke volume measurements with the bolus&#xD;
      thermodilution method while performing the echocardiography.&#xD;
&#xD;
      The acquired echocardiography loops will then be analysed and measured offline once deferred&#xD;
      consent has been obtained. We will then compare the echocardiographic measurements with the&#xD;
      measurement obtained by the pulmonary artery catheter (bolus method) - since this is the&#xD;
      current reference method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 2016</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of stroke volume measurement with three dimensional echocardiography to stroke volume measurement by thermodilution</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>The stroke volume of three to six heart beats will be measured after having performed an echocardiographic study. The stroke volume by thermodilution will be measured during the individual examination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of right ventricular pressure volume loops</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Off-line analysis of pressure time curve for right ventricle using data from pulmonary artery catheter and volume time curve from echocardiographic data. Assessment of feasibility to combine these two curves to a pressure volume loop.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Shock</condition>
  <arm_group>
    <arm_group_label>ICU patient</arm_group_label>
    <description>Critically ill patients in our adult intensive care unit with the following characteristics:&#xD;
advanced hemodynamic monitoring in place including pulmonary artery catheter and arterial catheter&#xD;
intubated or tracheostomy in place&#xD;
echocardiography requested by the treating physician&#xD;
intervention of interest: hemodynamic assessment done by echocardiography and thermodilution (pulmonary artery catheter)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult intensive care patients treated in our intensive care unit with current hemodynamic&#xD;
        unstable condition.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  advanced hemodynamic monitoring with pulmonary artery catheter and arterial catheter&#xD;
             in place&#xD;
&#xD;
          -  patient intubated or tracheostomy in place&#xD;
&#xD;
          -  clinical indication for performing an echocardiography&#xD;
&#xD;
          -  ongoing sedation requirement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Heart rhythm other than sinus rhythm or paced atrial rhythm&#xD;
&#xD;
          -  Known allergy to sulphur-hexafluoride (SonoVue©)&#xD;
&#xD;
          -  Artificial heart valves in place&#xD;
&#xD;
          -  Any form of mechanical cardiac assist&#xD;
&#xD;
          -  contraindication to performing a transesophageal echocardiography&#xD;
&#xD;
          -  presence of significant cardiac valve regurgitation&#xD;
&#xD;
          -  presence of an intracardiac shunt&#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_official>
    <last_name>Andreas Bloch, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>department of intensive care medicine, Inselspital, university hospital Berne, university of Berne, Switzerland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Andreas Bloch, MD</last_name>
    <phone>+41316325073</phone>
    <email>andreas.bloch@insel.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Tobias Merz, MD</last_name>
    <phone>+416322111</phone>
    <email>tobias.merz@insel.ch</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department for Intensive Care Medicine</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andreas Bloch</last_name>
      <phone>+41316325073</phone>
      <email>andreas.bloch@insel.ch</email>
    </contact>
    <contact_backup>
      <last_name>Tobias Merz</last_name>
      <phone>+41316322111</phone>
      <email>tobias.merz@insel.ch</email>
    </contact_backup>
    <investigator>
      <last_name>Andreas Bloch</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Tobias Merz</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>March 17, 2016</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Measurement of cardiac output</keyword>
  <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/NCT03270319
org study id: 16032016
nct id: NCT03270319
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Comparison of volumetric measurements obtained by three dimensional echocardiography with
      measurements obtained by thermodilution using a pulmonary artery catheter in the intensive
      care unit.
Prospective, observational study evaluating three dimensional echocardiography for measuring
      hemodynamic variables versus the current gold standard (pulmonary artery catheter).

      Critically ill patients with a severly compromised circulation due to a shock state with an
      advanced hemodynamic monitoring in place and the need for echocardiographic evaluation will
      be included.

      While performing an echocardiography study stroke volume measurements using the bolus method
      for thermodilution will concomittantly be measured.

      In case of insufficient image quality we are planning to use SonoVue echo contrast. Once the
      image quality has improved we will repeat the stroke volume measurements with the bolus
      thermodilution method while performing the echocardiography.

      The acquired echocardiography loops will then be analysed and measured offline once deferred
      consent has been obtained. We will then compare the echocardiographic measurements with the
      measurement obtained by the pulmonary artery catheter (bolus method) - since this is the
      current reference method.
observational model: Cohort
time perspective: Prospective
measure: Comparison of stroke volume measurement with three dimensional echocardiography to stroke volume measurement by thermodilution
time frame: through study completion, an average of 1 year
description: The stroke volume of three to six heart beats will be measured after having performed an echocardiographic study. The stroke volume by thermodilution will be measured during the individual examination.
measure: Feasibility of right ventricular pressure volume loops
time frame: through study completion, an average of 1 year
description: Off-line analysis of pressure time curve for right ventricle using data from pulmonary artery catheter and volume time curve from echocardiographic data. Assessment of feasibility to combine these two curves to a pressure volume loop.
arm group label: ICU patient
description: Critically ill patients in our adult intensive care unit with the following characteristics:
advanced hemodynamic monitoring in place including pulmonary artery catheter and arterial catheter
intubated or tracheostomy in place
echocardiography requested by the treating physician
intervention of interest: hemodynamic assessment done by echocardiography and thermodilution (pulmonary artery catheter)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andreas Bloch, MD
role: Principal Investigator
affiliation: department of intensive care medicine, Inselspital, university hospital Berne, university of Berne, Switzerland
last name: Andreas Bloch, MD
phone: +41316325073
email: andreas.bloch@insel.ch
last name: Tobias Merz, MD
phone: +416322111
email: tobias.merz@insel.ch
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Switzerland
responsible party type: Sponsor
sharing ipd: No