<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/NCT02989441</url>
  </required_header>
  <id_info>
    <org_study_id>H-16030081</org_study_id>
    <nct_id>NCT02989441</nct_id>
  </id_info>
  <brief_title>Perfusion Index in Anesthesia</brief_title>
  <official_title>Peripheral Perfusion Index as Marker for Systemic Hemodynamics During Anesthesia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jakob Højlund</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hvidovre University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients under general anesthesia the investigators wish to investigate association and&#xD;
      covariance between a peripheral perfusion index as obtained by Radical 7 monitor (Masimo,&#xD;
      Irvine, CA, USA) and more traditional hemodynamic parameters, ie. invasive blood pressure and&#xD;
      SV as obtained by LiDCO rapid monitor (LiDCO Ldt., London, UK)&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</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>Co-variance between Perfusion Index (PI) and Cardiac Output (CO) and Stroke Volume (SV)</measure>
    <time_frame>Intra-operative</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Co-variance between Perfusion Index (PI) and Mean Arterial Pressure (MAP)</measure>
    <time_frame>Intra-operative</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Monitoring, Physiological</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients for elective and sub-acute surgical repair of para-oesophagal hernia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients for elective and sub-acute surgical repair of para-oesophagal hernia.&#xD;
&#xD;
          -  Willingness to participate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicolai B Foss, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Hvidovre University Hospital, University of Copenhagen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hvidovre University Hospital</name>
      <address>
        <city>Hvidovre</city>
        <state>Capital Region</state>
        <zip>DK-2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>August 16, 2018</last_update_submitted>
  <last_update_submitted_qc>August 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hvidovre University Hospital</investigator_affiliation>
    <investigator_full_name>Jakob Højlund</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Perfusion Index</keyword>
  <keyword>Hemodynamics</keyword>
  <keyword>Anesthesia</keyword>
  <keyword>Stroke Volume</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>December 29, 2021</submitted>
    <returned>March 11, 2022</returned>
  </pending_results>
  <!-- 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/NCT02989441
org study id: H-16030081
nct id: NCT02989441
lead sponsor: 
has dmc: Yes
In patients under general anesthesia the investigators wish to investigate association and
      covariance between a peripheral perfusion index as obtained by Radical 7 monitor (Masimo,
      Irvine, CA, USA) and more traditional hemodynamic parameters, ie. invasive blood pressure and
      SV as obtained by LiDCO rapid monitor (LiDCO Ldt., London, UK)
observational model: Cohort
time perspective: Prospective
measure: Co-variance between Perfusion Index (PI) and Cardiac Output (CO) and Stroke Volume (SV)
time frame: Intra-operative
measure: Co-variance between Perfusion Index (PI) and Mean Arterial Pressure (MAP)
time frame: Intra-operative
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Nicolai B Foss, MD PhD
role: Study Chair
affiliation: Hvidovre University Hospital, University of Copenhagen
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Hvidovre University Hospital
investigator full name: Jakob Højlund
investigator title: Medical Doctor
sharing ipd: Undecided
submitted: December 29, 2021
returned: March 11, 2022