<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/NCT02197858</url>
  </required_header>
  <id_info>
    <org_study_id>HMPR1</org_study_id>
    <nct_id>NCT02197858</nct_id>
  </id_info>
  <brief_title>Comparability of Invasive and Non-invasive Haemodynamic Monitoring</brief_title>
  <acronym>HMPR1</acronym>
  <official_title>Clinical Comparison of Hemodynamic Parameters Using Invasive Versus Non-invasive Continuous Blood-pressure Technology During a Total Intravenous Anaesthesia (TIVA).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Erlangen-Nürnberg Medical School</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Erlangen-Nürnberg Medical School</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      During general anesthesia the basic non-invasive monitoring of hemodynamic parameters (blood&#xD;
      pressure, O2-saturation, cardiogram) is crucial. It can be enhanced to so called &quot;extended&#xD;
      hemodynamic monitoring&quot; depending on the operation and patient. Frequently an invasive&#xD;
      arterial cannula is used to provide continuous information on the blood pressure. This&#xD;
      invasive method is very accurate and clinically established, but can be linked to adverse&#xD;
      effects e.g. reduction of the circulation flow distal of the canulla, haematoma, infection&#xD;
      etc. ccNexfin (Edwards Lifescience) is a finger cuff measuring the blood pressure in a&#xD;
      non-invasive manner. It thus offers beat-to-beat information even about the extended&#xD;
      hemodynamic parameters as cardiac output (CO), cardiac index (CI), stroke volume (SV), stroke&#xD;
      volume index (SVI) and stroke volume variation (SSV), if connected to the clinical platform&#xD;
      EV1000 (Edwards Lifescience).&#xD;
&#xD;
      Assuming that the two methods are equal we plan to measure extended hemodynamic parameters&#xD;
      before, during induction and during ongoing anesthesia both invasive and non-invasive. Data&#xD;
      will be recorded every 30sec.&#xD;
&#xD;
      Clinical evaluation of the ccNexfin technology in respect to extended hemodynamic parameters&#xD;
      is to our knowledge rare and further assessment in this field is needed to offer patients a&#xD;
      potentially equally reliable but less invasive monitoring. Furthermore the study should model&#xD;
      the effect of remifentanil, propofol or its combination on haemodynamics .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Mean arterial pressure</measure>
    <time_frame>during anesthesia induction</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiac output</measure>
    <time_frame>during anesthesia induction</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke volume variation</measure>
    <time_frame>during anaesthesia induction</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stroke volume</measure>
    <time_frame>during anesthesia induction</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Heart rate</measure>
    <time_frame>during anaesthesia induction</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">40</enrollment>
  <condition>Anesthesia</condition>
  <condition>Anesthesia, Intravenous</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients that get an elective surgery under general anesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective surgery with the necessity of an arterial catheter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient not consented&#xD;
&#xD;
          -  peripheral vascular disease&#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 Hospital</name>
      <address>
        <city>Erlangen</city>
        <state>Bavaria</state>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>July 22, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>December 3, 2015</last_update_submitted>
  <last_update_submitted_qc>December 3, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Erlangen-Nürnberg Medical School</investigator_affiliation>
    <investigator_full_name>Tino Münster</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>invasive arterial pressure</keyword>
  <keyword>extended hemodynamic monitoring</keyword>
  <keyword>propofol</keyword>
  <keyword>remifentanil</keyword>
  <!-- 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/NCT02197858
org study id: HMPR1
nct id: NCT02197858
lead sponsor: 
has dmc: No
During general anesthesia the basic non-invasive monitoring of hemodynamic parameters (blood
      pressure, O2-saturation, cardiogram) is crucial. It can be enhanced to so called "extended
      hemodynamic monitoring" depending on the operation and patient. Frequently an invasive
      arterial cannula is used to provide continuous information on the blood pressure. This
      invasive method is very accurate and clinically established, but can be linked to adverse
      effects e.g. reduction of the circulation flow distal of the canulla, haematoma, infection
      etc. ccNexfin (Edwards Lifescience) is a finger cuff measuring the blood pressure in a
      non-invasive manner. It thus offers beat-to-beat information even about the extended
      hemodynamic parameters as cardiac output (CO), cardiac index (CI), stroke volume (SV), stroke
      volume index (SVI) and stroke volume variation (SSV), if connected to the clinical platform
      EV1000 (Edwards Lifescience).

      Assuming that the two methods are equal we plan to measure extended hemodynamic parameters
      before, during induction and during ongoing anesthesia both invasive and non-invasive. Data
      will be recorded every 30sec.

      Clinical evaluation of the ccNexfin technology in respect to extended hemodynamic parameters
      is to our knowledge rare and further assessment in this field is needed to offer patients a
      potentially equally reliable but less invasive monitoring. Furthermore the study should model
      the effect of remifentanil, propofol or its combination on haemodynamics .
observational model: Case-Only
time perspective: Prospective
measure: Mean arterial pressure
time frame: during anesthesia induction
measure: Cardiac output
time frame: during anesthesia induction
measure: Stroke volume variation
time frame: during anaesthesia induction
measure: Stroke volume
time frame: during anesthesia induction
measure: Heart rate
time frame: during anaesthesia induction
study pop: 
sampling method: 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 of Erlangen-Nürnberg Medical School
investigator full name: Tino Münster
investigator title: Prof. Dr.