<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/NCT02977481</url>
  </required_header>
  <id_info>
    <org_study_id>SHS-ED-11-2016</org_study_id>
    <nct_id>NCT02977481</nct_id>
  </id_info>
  <brief_title>Ear Temperature as Predictor of Rectal Temperature Measured With Modern Devices in the Emergency Department.</brief_title>
  <official_title>Ear Temperature, Measured With 3. Generation Tympanic Thermometers as Predictor of Rectal Temperature in the Emergency Department Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Southern Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ear thermometers are often requested to be used rather than rectal thermometer (gold&#xD;
      standard) for measuring the body temperature, as this method is faster and more user&#xD;
      friendly. Former ear thermometers did not meet the required standards of accuracy for&#xD;
      clinical use. However, a new generation of ear thermometers have been developed and widely&#xD;
      used in the Emergency departments in Denmark. The devices have only been evaluated in two&#xD;
      studies on adult populations, with conflicting results.&#xD;
&#xD;
      This cross-sectional study will examine patients by measuring both ear and rectal temperature&#xD;
      in the same patient at the same time on admission to an emergency department, to evaluate if&#xD;
      temperature measured in the ear can be used as the standard temperature measurement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The Body Temperature in Celcius degrees</measure>
    <time_frame>Up to 24 hours after arrival to Emergency Department</time_frame>
  </primary_outcome>
  <enrollment type="Actual">600</enrollment>
  <condition>Fever</condition>
  <eligibility>
    <study_pop>
      <textblock>
        600 adult patients admitted to emergency department&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  admission to emergency department&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  no rectum&#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>Aabenraa Sygehus Emergency Department</name>
      <address>
        <city>Aabenraa</city>
        <zip>6200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>May 17, 2017</last_update_submitted>
  <last_update_submitted_qc>May 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern Denmark</investigator_affiliation>
    <investigator_full_name>Christian Backer Mogensen</investigator_full_name>
    <investigator_title>asst professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Emergencies</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/NCT02977481
org study id: SHS-ED-11-2016
nct id: NCT02977481
lead sponsor: 
has dmc: No
Ear thermometers are often requested to be used rather than rectal thermometer (gold
      standard) for measuring the body temperature, as this method is faster and more user
      friendly. Former ear thermometers did not meet the required standards of accuracy for
      clinical use. However, a new generation of ear thermometers have been developed and widely
      used in the Emergency departments in Denmark. The devices have only been evaluated in two
      studies on adult populations, with conflicting results.

      This cross-sectional study will examine patients by measuring both ear and rectal temperature
      in the same patient at the same time on admission to an emergency department, to evaluate if
      temperature measured in the ear can be used as the standard temperature measurement.
observational model: Other
time perspective: Cross-Sectional
measure: The Body Temperature in Celcius degrees
time frame: Up to 24 hours after arrival to Emergency Department
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: University of Southern Denmark
investigator full name: Christian Backer Mogensen
investigator title: asst professor
mesh term: Emergencies
sharing ipd: No