<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/NCT02206997</url>
  </required_header>
  <id_info>
    <org_study_id>THER-GUIDE-EVA</org_study_id>
    <nct_id>NCT02206997</nct_id>
  </id_info>
  <brief_title>Evaluation of a Patient Warming Concept Following the German S3 Guideline for Prevention of Intraoperative Hypothermia</brief_title>
  <official_title>Evaluation of a Patient Warming Concept Following the New German Speaking S3 Guideline for Prevention of Intraoperative Hypothermia With Respect to Incidence and Complications of Perioperative Hypothermia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Schleswig-Holstein</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Schleswig-Holstein</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate a patient prewarming concept following the&#xD;
      recommendations of the S3-guideline &quot;Prevention of perioperative hypothermia&quot; with respect to&#xD;
      incidence and complications of perioperative hypothermia. The study hypothesis is that&#xD;
      postoperative core temperature in adult patients after prewarming is significantly higher&#xD;
      than in patients who were treated following actual standard protocol (passive insulation).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to evaluate a patient prewarming concept following the&#xD;
      recommendations of the new german S3-guideline &quot;Prevention of perioperative hypothermia&quot; with&#xD;
      respect to incidence and complications of perioperative hypothermia. Prewarming should enable&#xD;
      the patients to preserve their core temperature for a longer period and to avoid&#xD;
      perioperative hypothermia.The study hypothesis is that postoperative core temperature in&#xD;
      adult patients after prewarming is significantly higher than in patients who were treated&#xD;
      following the actual standard protocol (passive insulation).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</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>Incidence of postoperative hypothermia at admission to PACU</measure>
    <time_frame>admission to PACU</time_frame>
    <description>The incidence of postoperative hypothermia at admission to PACU should be evaluated by sublingual temperature measurement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Type and duration of surgery as influence factors for postoperative hypothermia at admission to PACU</measure>
    <time_frame>admission to PACU</time_frame>
    <description>Type and duration of surgery should be evaluated as influence factors for postoperative hypothermia at admission to PACU?</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">485</enrollment>
  <condition>Hypothermia</condition>
  <condition>Hypothermia, Accidental</condition>
  <arm_group>
    <arm_group_label>Passive Insulation standard treatment</arm_group_label>
    <description>no active warming before start of anesthesia and no active warming at PACU</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active prewarming treatment</arm_group_label>
    <description>active warming before start of anesthesia and active warming at PACU following recommendations of S3-guideline</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients of FEK Hospital Neumünster scheduled for elective surgery under defined conditions&#xD;
        (see below)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients scheduled for elective general or orthopedic surgery with expected duration &gt;&#xD;
             45 min&#xD;
&#xD;
          -  American Society of Anesthesiologists physical status 1-3&#xD;
&#xD;
          -  age &gt; 17 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency surgery&#xD;
&#xD;
          -  patient's denial&#xD;
&#xD;
          -  unexpected decrease of duration of anesthesia &lt; 45 min&#xD;
&#xD;
          -  preoperative body temperature &gt; 38 °C&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan H Hoecker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>FEK Hospital Neumünster</name>
      <address>
        <city>Neumünster</city>
        <state>Schleswig-Holstein</state>
        <zip>24534</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>May 1, 2017</last_update_submitted>
  <last_update_submitted_qc>May 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Schleswig-Holstein</investigator_affiliation>
    <investigator_full_name>PD Dr. Jan Hoecker</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>perioperative hypothermia</keyword>
  <keyword>prewarming</keyword>
  <keyword>treatment guideline</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothermia</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/NCT02206997
org study id: THER-GUIDE-EVA
nct id: NCT02206997
lead sponsor: 
has dmc: No
The aim of the study is to evaluate a patient prewarming concept following the
      recommendations of the S3-guideline "Prevention of perioperative hypothermia" with respect to
      incidence and complications of perioperative hypothermia. The study hypothesis is that
      postoperative core temperature in adult patients after prewarming is significantly higher
      than in patients who were treated following actual standard protocol (passive insulation).
The aim of the study is to evaluate a patient prewarming concept following the
      recommendations of the new german S3-guideline "Prevention of perioperative hypothermia" with
      respect to incidence and complications of perioperative hypothermia. Prewarming should enable
      the patients to preserve their core temperature for a longer period and to avoid
      perioperative hypothermia.The study hypothesis is that postoperative core temperature in
      adult patients after prewarming is significantly higher than in patients who were treated
      following the actual standard protocol (passive insulation).
observational model: Cohort
time perspective: Prospective
measure: Incidence of postoperative hypothermia at admission to PACU
time frame: admission to PACU
description: The incidence of postoperative hypothermia at admission to PACU should be evaluated by sublingual temperature measurement.
measure: Type and duration of surgery as influence factors for postoperative hypothermia at admission to PACU
time frame: admission to PACU
description: Type and duration of surgery should be evaluated as influence factors for postoperative hypothermia at admission to PACU?
arm group label: Passive Insulation standard treatment
description: no active warming before start of anesthesia and no active warming at PACU
arm group label: Active prewarming treatment
description: active warming before start of anesthesia and active warming at PACU following recommendations of S3-guideline
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Jan H Hoecker, MD
role: Principal Investigator
affiliation: University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Schleswig-Holstein
investigator full name: PD Dr. Jan Hoecker
investigator title: MD
mesh term: Hypothermia