xml: <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/NCT06010069</url>
    </required_header>
    <id_info>
      <org_study_id>22.11.2022 No: 2022-21/187</org_study_id>
      <nct_id>NCT06010069</nct_id>
    </id_info>
    <brief_title>The Relationship Between the Frequency of Intraoperative Hypothermia and Fragility Scores</brief_title>
    <official_title>The Relationship Between the Frequency of Intraoperative Hypothermia and Fragility Scores in the Elderly Patient Group. Prospective Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Kirsehir Ahi Evran Universitesi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Kirsehir Ahi Evran Universitesi</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to compare frequency of intraoperative hypothermia&#xD;
        between fragilitly groups of eldery patients who underwent orthopedic surgical procedures.&#xD;
  &#xD;
        It aims to answer those questions:&#xD;
  &#xD;
          -  İs there any difference between fragility groups in terms of hypothermia frequency&#xD;
             during orthopedic surgical procedures?&#xD;
  &#xD;
          -  Are there any other factors that influence the frequency of hypothermia such as age,&#xD;
             body mass index, room temperature etc. ? Participants body temperature before anestesia&#xD;
             application,and before surgery had started was measured and measurament was done during&#xD;
             whole procedure. Measuraments had been done by tympanic thermometer.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 30, 2022</start_date>
    <completion_date type="Actual">July 1, 2023</completion_date>
    <primary_completion_date type="Actual">June 1, 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>frequency of hypothermia</measure>
      <time_frame>during the orthopedic surgical procedure</time_frame>
      <description>difference between frailty groups in terms of frequency of hypothermia</description>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Actual">90</enrollment>
    <condition>Hypothermia; Anesthesia</condition>
    <condition>Fragility</condition>
    <arm_group>
      <arm_group_label>pre-frail patients</arm_group_label>
      <description>That patient group have clinical frailty scale scores 1,2 or 3 which is accepted as non-frail.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>frail patients</arm_group_label>
      <description>That patient group have clinical frailty scale scores 4 or 5 which is accepted as frail.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>very frail patients</arm_group_label>
      <description>That patient group have clinical frailty scale scores 6,7,8 or 9 which is accepted as severly frail.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>body temperature measurament</intervention_name>
      <description>body temperature of every patient was measured with tympanic thermometer during surgical procedure</description>
      <arm_group_label>frail patients</arm_group_label>
      <arm_group_label>pre-frail patients</arm_group_label>
      <arm_group_label>very frail patients</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Our candidates was choosen from patiens who scheduled for elective orthopedic surgeries in&#xD;
          Kirsehir education and research hospital. We have enrolled patients who accepted to be a&#xD;
          partician for this study after obtaining their informed consent. Elective Orthopedic&#xD;
          Surgery. All of our participants were 65 years old or older.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Elective Orthopedic Surgery Candidates&#xD;
  &#xD;
            -  65 years old or older&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Emergency surgery&#xD;
  &#xD;
            -  Patiens who required multiple (2 or more) blood component transfusions&#xD;
  &#xD;
            -  Neurologic disorders&#xD;
  &#xD;
            -  tyroid dysfunction&#xD;
  &#xD;
            -  Patiens who are already hypothermic before surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Kırşehir Eğitim ve Araştırma Hastanesi</name>
        <address>
          <city>Kırşehir</city>
          <state>Merkez</state>
          <zip>04100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Kirsehir Ahi Evran Universitesi</investigator_affiliation>
      <investigator_full_name>Fatma Nur Arslan</investigator_full_name>
      <investigator_title>Medical Docdor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hypothermia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>After the statistical analyzes we will most likely to share IPDs</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06010069
  org study id: 22.11.2022 No: 2022-21/187
  nct id: NCT06010069
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to compare frequency of intraoperative hypothermia
        between fragilitly groups of eldery patients who underwent orthopedic surgical procedures.
  
        It aims to answer those questions:
  
          -  İs there any difference between fragility groups in terms of hypothermia frequency
             during orthopedic surgical procedures?
  
          -  Are there any other factors that influence the frequency of hypothermia such as age,
             body mass index, room temperature etc. ? Participants body temperature before anestesia
             application,and before surgery had started was measured and measurament was done during
             whole procedure. Measuraments had been done by tympanic thermometer.
  observational model: Cohort
  time perspective: Prospective
  measure: frequency of hypothermia
  time frame: during the orthopedic surgical procedure
  description: difference between frailty groups in terms of frequency of hypothermia
  arm group label: pre-frail patients
  description: That patient group have clinical frailty scale scores 1,2 or 3 which is accepted as non-frail.
  arm group label: frail patients
  description: That patient group have clinical frailty scale scores 4 or 5 which is accepted as frail.
  arm group label: very frail patients
  description: That patient group have clinical frailty scale scores 6,7,8 or 9 which is accepted as severly frail.
  intervention type: Diagnostic Test
  intervention name: body temperature measurament
  description: body temperature of every patient was measured with tympanic thermometer during surgical procedure
  arm group label: frail patients
  arm group label: pre-frail patients
  arm group label: very frail patients
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: 100 Years
  healthy volunteers: No
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Kirsehir Ahi Evran Universitesi
  investigator full name: Fatma Nur Arslan
  investigator title: Medical Docdor
  mesh term: Hypothermia
  sharing ipd: Undecided
  ipd description: After the statistical analyzes we will most likely to share IPDs