<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/NCT02992002</url>
  </required_header>
  <id_info>
    <org_study_id>EIT Fluid Challenge</org_study_id>
    <nct_id>NCT02992002</nct_id>
  </id_info>
  <brief_title>Influence of Fluid Challenge on End-Expiratory Lung Impedance in Mechanically Ventilated Patients Monitored With Electrical Impedance Tomography</brief_title>
  <official_title>Influence of Fluid Challenge on End-Expiratory Lung Impedance in Mechanically Ventilated Patients Monitored With Electrical Impedance Tomography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Schleswig-Holstein</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Schleswig-Holstein</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study investigates the influence of a clinically indicated fluid challenge on&#xD;
      end-expiratory lung impedance, assessed by electrical impedance tomography (EIT). EIT data&#xD;
      will be collected before, during and after infusion of 500 ml of crystalloid solution in&#xD;
      mechanically ventilated patients on an operative intensive care unit.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">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>Change in end-expiratory lung impedance (EELI)</measure>
    <time_frame>15-30 minutes</time_frame>
    <description>To assess the effect of fluid challenge on EELI, the change in EELI during the fluid challenge will be measured by electrical impedance tomography and will be compared to the change in EELI during the last 15 minutes before start of the fluid challenge.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between change in end-expiratory lung impedance and change in intrathoracic blood volume</measure>
    <time_frame>15-30 minutes</time_frame>
    <description>We will assess the correlation between the change in end-expiratory lung impedance during infusion of 500 ml of crystalloid solution and the change in intrathoracic blood volume (assessed by transpulmonary thermodilution) during the same time period.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluid responsiveness</measure>
    <time_frame>15-30 minutes</time_frame>
    <description>We will investigate whether the ratio of cardiac-related impedance changes to ventilation-related impedance changes, measured by EIT at baseline (i.e. before start of fluid challenge), can predict fluid responsiveness, defined as an increase in stroke volume of greater or equal to 15% compared to baseline.</description>
  </secondary_outcome>
  <enrollment type="Actual">25</enrollment>
  <condition>Respiratory Failure</condition>
  <condition>Circulatory Failure</condition>
  <condition>Fluid Responsiveness</condition>
  <condition>Fluid Overload</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fluid Challenge</intervention_name>
    <description>Infusion of a standardized amount of crystalloid solution (500 ml) to assess fluid responsiveness by means of changes in cardiac output, assessed by transpulmonary thermodilution.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Mixed population of intensive care unit patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients on mechanical ventilation&#xD;
&#xD;
          -  clincial decision to monitor regional ventilation with electrical impedance tomography&#xD;
&#xD;
          -  clinical indication for fluid challenge&#xD;
&#xD;
          -  established cardiac output monitoring with transpulmonary thermodilution&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18 years&#xD;
&#xD;
          -  open lung injuries&#xD;
&#xD;
          -  instable injury of spine or cranium&#xD;
&#xD;
          -  thoracic metal implants&#xD;
&#xD;
          -  body mass index &gt; 35&#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>University Medical Center Schleswig Holstein, Campus Kiel</name>
      <address>
        <city>Kiel</city>
        <state>Schleswig-Holstein</state>
        <zip>24145</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>May 2, 2018</last_update_submitted>
  <last_update_submitted_qc>May 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Schleswig-Holstein</investigator_affiliation>
    <investigator_full_name>Tobias Becher</investigator_full_name>
    <investigator_title>Dr Tobias Becher</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <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/NCT02992002
org study id: EIT Fluid Challenge
nct id: NCT02992002
lead sponsor: 
has dmc: No
The study investigates the influence of a clinically indicated fluid challenge on
      end-expiratory lung impedance, assessed by electrical impedance tomography (EIT). EIT data
      will be collected before, during and after infusion of 500 ml of crystalloid solution in
      mechanically ventilated patients on an operative intensive care unit.
observational model: Cohort
time perspective: Prospective
measure: Change in end-expiratory lung impedance (EELI)
time frame: 15-30 minutes
description: To assess the effect of fluid challenge on EELI, the change in EELI during the fluid challenge will be measured by electrical impedance tomography and will be compared to the change in EELI during the last 15 minutes before start of the fluid challenge.
measure: Correlation between change in end-expiratory lung impedance and change in intrathoracic blood volume
time frame: 15-30 minutes
description: We will assess the correlation between the change in end-expiratory lung impedance during infusion of 500 ml of crystalloid solution and the change in intrathoracic blood volume (assessed by transpulmonary thermodilution) during the same time period.
measure: Fluid responsiveness
time frame: 15-30 minutes
description: We will investigate whether the ratio of cardiac-related impedance changes to ventilation-related impedance changes, measured by EIT at baseline (i.e. before start of fluid challenge), can predict fluid responsiveness, defined as an increase in stroke volume of greater or equal to 15% compared to baseline.
intervention type: Other
intervention name: Fluid Challenge
description: Infusion of a standardized amount of crystalloid solution (500 ml) to assess fluid responsiveness by means of changes in cardiac output, assessed by transpulmonary thermodilution.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Schleswig-Holstein
investigator full name: Tobias Becher
investigator title: Dr Tobias Becher
mesh term: Respiratory Insufficiency
mesh term: Shock
sharing ipd: No