<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/NCT02220101</url>
  </required_header>
  <id_info>
    <org_study_id>1A</org_study_id>
    <nct_id>NCT02220101</nct_id>
  </id_info>
  <brief_title>Temperature Measurement in Surgical and Intensive Care Patients - Comparison of Four Measurement Methods</brief_title>
  <acronym>Temp</acronym>
  <official_title>Temperature Measurement in Surgical and Intensive Care Patients - Comparison of Four Measurement Methods</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sykehuset i Vestfold HF</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>3M</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sykehuset i Vestfold HF</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Comparison of four methods for measuring temperature perioperatively in patients scheduled&#xD;
      for laparoscopic surgery and intensive care patients who are hypo-, normo-and hyper terme;&#xD;
      Bladder Monitoring, Nasopharyngeal, SpotOn TM, Zero heat flux method and Temporal Scanner.&#xD;
      The study is a single-center, observational study carried out by the Central Surgical and&#xD;
      Intensive Section at Vestfold Hospital Trust.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Issues&#xD;
&#xD;
        -  Perioperative hypothermia is associated with several serious complications and therefore&#xD;
           most likely to be avoided. Monitoring of body temperature is therefore required&#xD;
           perioperatively .&#xD;
&#xD;
        -  There are in the literature concerns that some methods of measuring temperature&#xD;
           perioperatively is accurate enough and whether they reflect core temperature adequate.&#xD;
&#xD;
        -  Some authors have questioned whether temporal scanner (TS ) - and nasopharynx ( NP) -&#xD;
           measurements are accurate enough to measure the actual core temperature. Much of the&#xD;
           research on TS measurements have been done on children and newborns in an intensive&#xD;
           setting, but little perioperatively .&#xD;
&#xD;
      A total of 120 patients will be included ; 60 at Central Operations and 60 at Intensive&#xD;
      Section at the Vestfold Hospital Trust. Duration of inclusion will be approximately one year&#xD;
      . Starting around January 2014. The study emanates from Vestfold Hospital Trust and was&#xD;
      designed by Espen Lindholm who is responsible for the project , Camilla B Norén who is&#xD;
      principal investigator and project manager. Kjetil G Ringdal , Karl - André Wian and Knut&#xD;
      Arvid Kirkebøen (University Hospital of Oslo ) are supervisors. The study is supported by&#xD;
      research, Vestfold Hospital Trust and 3M Company Norway (study material ) and it is applied&#xD;
      Regional Ethics Committee. Patients will not get different treatment than standard treatment&#xD;
      in hospital and it causes no follow-up calls or hospital visits. All patients (if possible)&#xD;
      give written consent for participation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">January 2023</completion_date>
  <primary_completion_date type="Actual">January 2023</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>Temperature difference measured with different measuring methods</measure>
    <time_frame>Timepoints during surgery; Every 20th minute. In intensive patients: 3 measurements during 1 hour (every 20th minute)</time_frame>
    <description>The difference in temperature between the temperature measured by the current reference method bladder temperature and the temperature measured with Temporal Scanner, SpotOn and nasopharynx through the entire operational sequence (from first to last measurement) and three individual measurements at 20 minute intervals of intensive care patients.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with 1) Sore after Sticker (SpotOn) 2) epistaxis during hospital stay as a measure of safety and tolerability.</measure>
    <time_frame>Hospital discharge</time_frame>
    <description>An average of 10 days</description>
  </secondary_outcome>
  <enrollment type="Actual">95</enrollment>
  <condition>Hypothermia</condition>
  <condition>Hyperthermia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Laparoscopic surgery and in ICU patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Surgical Patient group:&#xD;
&#xD;
          -  &gt; 18 years&#xD;
&#xD;
          -  ASA 1-3&#xD;
&#xD;
          -  Laparoscopic surgery&#xD;
&#xD;
          -  Elective surgery&#xD;
&#xD;
        Intensive Patient group:&#xD;
&#xD;
          -  &gt; 18 years&#xD;
&#xD;
          -  Defined as intensive patient&#xD;
&#xD;
          -  ASA 1-5&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Surgical Patient group:&#xD;
&#xD;
          -  BMI&gt; 30 kg/m2&#xD;
&#xD;
          -  No bladder (ileum-bladder)&#xD;
&#xD;
          -  Known malignant hyperthermia&#xD;
&#xD;
          -  Malformations of the face that prevents nasopharynx and temporal scanner measurements&#xD;
&#xD;
          -  Patient is participating in another study that may influence the results of the&#xD;
             Tempstudy&#xD;
&#xD;
          -  The patient is not competent to give consent, eg severe dementia&#xD;
&#xD;
          -  The patient INR&gt; 2.0 and / or Trc &lt;50&#xD;
&#xD;
        Intensive Patient group:&#xD;
&#xD;
          -  BMI&gt; 30 kg/m2&#xD;
&#xD;
          -  No bladder (ileum-bladder)&#xD;
&#xD;
          -  Malformations of the face that prevents nasopharynx and temporal scanner measurements&#xD;
&#xD;
          -  Hypothermic patient below 32 ° C (bladder temperature)&#xD;
&#xD;
          -  Hyperterm patient over 40 ° C (bladder temperature)&#xD;
&#xD;
          -  Active cooling of the bladder&#xD;
&#xD;
          -  The patient is under ongoing cooling or heating&#xD;
&#xD;
          -  Patient is participating in another study that may influence the results of the&#xD;
             Tempstudy&#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>Espen Lindholm, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Departement of Anesthesiology, Vestfold Hospital Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vestfold Hospital Trust</name>
      <address>
        <city>Tønsberg</city>
        <zip>3103</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>February 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>January 2, 2023</last_update_submitted>
  <last_update_submitted_qc>January 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sykehuset i Vestfold HF</investigator_affiliation>
    <investigator_full_name>Espen Lindholm</investigator_full_name>
    <investigator_title>Chief of Department of Anesthesiology section</investigator_title>
  </responsible_party>
  <keyword>hypothermia</keyword>
  <keyword>core temperature</keyword>
  <keyword>temperature measurement methods</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothermia</mesh_term>
    <mesh_term>Hyperthermia</mesh_term>
  </condition_browse>
  <!-- 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/NCT02220101
org study id: 1A
nct id: NCT02220101
lead sponsor: 
collaborator: 
has dmc: No
Comparison of four methods for measuring temperature perioperatively in patients scheduled
      for laparoscopic surgery and intensive care patients who are hypo-, normo-and hyper terme;
      Bladder Monitoring, Nasopharyngeal, SpotOn TM, Zero heat flux method and Temporal Scanner.
      The study is a single-center, observational study carried out by the Central Surgical and
      Intensive Section at Vestfold Hospital Trust.
Issues

        -  Perioperative hypothermia is associated with several serious complications and therefore
           most likely to be avoided. Monitoring of body temperature is therefore required
           perioperatively .

        -  There are in the literature concerns that some methods of measuring temperature
           perioperatively is accurate enough and whether they reflect core temperature adequate.

        -  Some authors have questioned whether temporal scanner (TS ) - and nasopharynx ( NP) -
           measurements are accurate enough to measure the actual core temperature. Much of the
           research on TS measurements have been done on children and newborns in an intensive
           setting, but little perioperatively .

      A total of 120 patients will be included ; 60 at Central Operations and 60 at Intensive
      Section at the Vestfold Hospital Trust. Duration of inclusion will be approximately one year
      . Starting around January 2014. The study emanates from Vestfold Hospital Trust and was
      designed by Espen Lindholm who is responsible for the project , Camilla B Norén who is
      principal investigator and project manager. Kjetil G Ringdal , Karl - André Wian and Knut
      Arvid Kirkebøen (University Hospital of Oslo ) are supervisors. The study is supported by
      research, Vestfold Hospital Trust and 3M Company Norway (study material ) and it is applied
      Regional Ethics Committee. Patients will not get different treatment than standard treatment
      in hospital and it causes no follow-up calls or hospital visits. All patients (if possible)
      give written consent for participation.
observational model: Case-Only
time perspective: Prospective
measure: Temperature difference measured with different measuring methods
time frame: Timepoints during surgery; Every 20th minute. In intensive patients: 3 measurements during 1 hour (every 20th minute)
description: The difference in temperature between the temperature measured by the current reference method bladder temperature and the temperature measured with Temporal Scanner, SpotOn and nasopharynx through the entire operational sequence (from first to last measurement) and three individual measurements at 20 minute intervals of intensive care patients.
measure: Number of patients with 1) Sore after Sticker (SpotOn) 2) epistaxis during hospital stay as a measure of safety and tolerability.
time frame: Hospital discharge
description: An average of 10 days
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Espen Lindholm, M.D.
role: Study Director
affiliation: Departement of Anesthesiology, Vestfold Hospital Trust
facility: 
country: Norway
responsible party type: Principal Investigator
investigator affiliation: Sykehuset i Vestfold HF
investigator full name: Espen Lindholm
investigator title: Chief of Department of Anesthesiology section
mesh term: Hypothermia
mesh term: Hyperthermia