<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/NCT04489927</url>
  </required_header>
  <id_info>
    <org_study_id>Tcore-PMCF</org_study_id>
    <nct_id>NCT04489927</nct_id>
  </id_info>
  <brief_title>Validation of the Measurement Accuracy of the Tcore Thermometer</brief_title>
  <acronym>T-CORE-PMCF</acronym>
  <official_title>Validierung Der Messgenauigkeit Des Tcore Thermometers in Der Anwendung Nicht-invasiver Temperaturmessung gegenüber herkömmlicher Invasiver Messung Auf Der Intensivstation Bei Wachen Patienten</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Drägerwerk AG &amp; Co. KGaA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Drägerwerk AG &amp; Co. KGaA</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>
      The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the&#xD;
      body core temperature thermometer Tcore®. Therefore the bias of the measurements to the&#xD;
      reference measurements of the bladder catheter thermometer is determined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the&#xD;
      body core temperature thermometer Tcore®. Therefore the bias of the measurements to the&#xD;
      reference measurements of the bladder catheter thermometer is determined.&#xD;
&#xD;
      Patients included are in the ICU of the UKSH and awake. They already have the reference&#xD;
      thermometer in the catheter. The patient investigation time is limited to maximum 2 hours,&#xD;
      SAEs will be recorded for 24 hours. The temperature of the two temperature sensors will be&#xD;
      compared on three timepoints.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Patients couldn't be recruited (no patients with fewer available)&#xD;
  </why_stopped>
  <start_date type="Actual">October 1, 2021</start_date>
  <completion_date type="Actual">April 17, 2023</completion_date>
  <primary_completion_date type="Actual">April 11, 2023</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>Temperature</measure>
    <time_frame>within 24 hours</time_frame>
    <description>Temperature measurements with reference thermometer Tcore®</description>
  </primary_outcome>
  <enrollment type="Actual">75</enrollment>
  <condition>Temperature Change, Body</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tcore</intervention_name>
    <description>Temperature Measurement of standard care versus the Tcore measurement</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients in the ICU of the University Hospital Schleswig-Holstein&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Body temperature &gt; 34 °C&#xD;
&#xD;
          -  Signed consent&#xD;
&#xD;
          -  Bladder catheter with temperature sensor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inflammation of the frontal sinus or the measuring point of the reference measurement&#xD;
             (bladder)&#xD;
&#xD;
          -  Skin irritation to the adhesive or other materials used&#xD;
&#xD;
          -  medication that locally affects the body temperature or the temperature of the&#xD;
             reference body site (barbiturates, thyroid preparations, antipsychotics, new vaccines,&#xD;
             aspirin, acetaminophen, ibuprofen, or similar)&#xD;
&#xD;
          -  Taking antipyretics in the last 120 minutes before measurement&#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>Tobias Graf, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Schleswig-Holstein Lübeck</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Schleswig-Holstein</name>
      <address>
        <city>Lübeck</city>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>August 17, 2023</last_update_submitted>
  <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 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>Body Temperature Changes</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/NCT04489927
org study id: Tcore-PMCF
nct id: NCT04489927
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the
      body core temperature thermometer Tcore®. Therefore the bias of the measurements to the
      reference measurements of the bladder catheter thermometer is determined.
The aim of the study conducted at the UKSH is to investigate the measuring accuracy of the
      body core temperature thermometer Tcore®. Therefore the bias of the measurements to the
      reference measurements of the bladder catheter thermometer is determined.

      Patients included are in the ICU of the UKSH and awake. They already have the reference
      thermometer in the catheter. The patient investigation time is limited to maximum 2 hours,
      SAEs will be recorded for 24 hours. The temperature of the two temperature sensors will be
      compared on three timepoints.
observational model: Cohort
time perspective: Prospective
measure: Temperature
time frame: within 24 hours
description: Temperature measurements with reference thermometer Tcore®
intervention type: Device
intervention name: Tcore
description: Temperature Measurement of standard care versus the Tcore measurement
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tobias Graf, Dr.
role: Principal Investigator
affiliation: University Schleswig-Holstein Lübeck
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Body Temperature Changes
sharing ipd: No