<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/NCT02211703</url>
  </required_header>
  <id_info>
    <org_study_id>MDI0091</org_study_id>
    <nct_id>NCT02211703</nct_id>
  </id_info>
  <brief_title>National Epidemiologic Survey on the Incidence of Perioperative Hypothermia</brief_title>
  <official_title>National Epidemiologic Survey on the Incidence of Perioperative Hypothermia in Patients With Elective Surgery Under General Anesthesia in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jie YI</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Medical Consulting Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study Objective:&#xD;
&#xD;
        -  to project the incidence of perioperative hypothermia in patients with elective surgery&#xD;
           under general anesthesia in China&#xD;
&#xD;
        -  to determine the risk factors associated with perioperative hypothermia.&#xD;
&#xD;
        -  to explore the patient outcome of hypothermia such as cardiovascular events, wound&#xD;
           infection,hospital stay and so on.&#xD;
&#xD;
      Study Design: The present study is a cross-sectional study with 30-day follow-up period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This survey was anticipated to enroll 2208 patients with elective surgery under general&#xD;
      anesthesia from 28 hospitals or so in China. After obtaining approval from the Ethical&#xD;
      Committee related to research involving human subjects,the investigators will enroll the&#xD;
      patients according to the inclusion and exclusion criterion. The tympanic temperature will be&#xD;
      monitored at the following time points respectively: Arriving at waiting area, entering the&#xD;
      OR room, 5 min before and after anesthesia induction, every 15 min during the operation,&#xD;
      after 2h the tympanic temperature will be monitored at every 30 min, Tympanic temperature&#xD;
      will also be taken when the surgery complete and when patients arrived at PACU. Other&#xD;
      information will also be collected including the type and dosage of anesthesia drug,duration&#xD;
      of surgery and anesthesia, patient warming method，operation room temperature, the amount of&#xD;
      the infusion of intravenous fluids and blood and their warming techniques during the whole&#xD;
      operation procedure. The postoperative follow-up will be conducted and recorded within 30&#xD;
      days after operation(for implantation surgery, the follow-up will be conducted within 90 days&#xD;
      postoperatively ) which includes ICU stays, hospital stays, wound infection, new&#xD;
      cardiovascular events.etc.&#xD;
&#xD;
      The contract research organization will be delegated to do an on site monitor once a month&#xD;
      (online monitor once a week) for each hospital participate the survey during the recruitment&#xD;
      and perform the source data validation at the same time to review the related medical&#xD;
      records,source data and the case report forms, etc.to ensure the data accuracy and&#xD;
      completeness.&#xD;
&#xD;
      Data management will be conducted through the whole survey procedure. In order to guarantee&#xD;
      the validation of the data, two data managing staffs will input and verify the data&#xD;
      independently.&#xD;
&#xD;
      Statistical analysis software (SAS9.2) was used for the calculation of all the statistical&#xD;
      analyses. The number of cases, mean, standard deviation, median value, maximal value and&#xD;
      minimal value should be calculated for the descriptions of the qualitative parameters. Number&#xD;
      of cases and percentages are used for the descriptions on the classification parameters.Two&#xD;
      side test is used for all the statistical tests, P&lt;0.05 indicates that the difference is&#xD;
      statistically significant (unless indicated otherwise), and 95% confidence is used as the&#xD;
      confidence interval.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">October 2015</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>the incidence of perioperative hypothermia</measure>
    <time_frame>from patients entered operating room to transfering to post anesthesia care units</time_frame>
    <description>The core temperatures (tympanic membrane) will be measured at various time points to identify the occurence of hypothermia</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>record the postoperative adverse events</measure>
    <time_frame>From the day after operation to 30 days thereafter</time_frame>
    <description>To identify the hypothermia related adverse events, such as cardiovascular events, wound infection, hospital stays and so on.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2208</enrollment>
  <condition>Hypothermia</condition>
  <arm_group>
    <arm_group_label>Observation</arm_group_label>
    <description>This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients with elective operation under general anesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female，age≥18 Subjects will undergo an elective surgeries with general&#xD;
             anaesthesia The duration of operation is expected to be over 60 minutes The subjects&#xD;
             agreed to participate in the study and signed the consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Central high fever, including that induced by cerebrovascular, disease, cerebral&#xD;
             trauma, cerebral, surgeries, epilepsy and acute hydrocephalus Thermoregulation&#xD;
             abnormalities including malignant hyperthermia (MHS) and neuroleptic malignant&#xD;
             syndrome Hypothyroidism or hyperthyroidism diagnosed by substantial evidence&#xD;
             Infectious fever Temperature is higher than 37.8℃ within 3 days before surgery&#xD;
             Diseases or surgery that may lead to inaccuracy in measurement of era thermometer ,&#xD;
             such as ear infection etc.&#xD;
&#xD;
        Surgeries with active cooling process during operation&#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>Yuguang Huang, doctoral</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Jie Yi, Doctoral</last_name>
      <phone>+86 10 69152025</phone>
      <email>easyue@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 7, 2014</study_first_posted>
  <last_update_submitted>August 6, 2014</last_update_submitted>
  <last_update_submitted_qc>August 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 7, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Jie YI</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>perioperative hypothermia</keyword>
  <keyword>Epidemiology</keyword>
  <keyword>Tympanic temperature</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/NCT02211703
org study id: MDI0091
nct id: NCT02211703
lead sponsor: 
collaborator: 
has dmc: No
Study Objective:

        -  to project the incidence of perioperative hypothermia in patients with elective surgery
           under general anesthesia in China

        -  to determine the risk factors associated with perioperative hypothermia.

        -  to explore the patient outcome of hypothermia such as cardiovascular events, wound
           infection,hospital stay and so on.

      Study Design: The present study is a cross-sectional study with 30-day follow-up period.
This survey was anticipated to enroll 2208 patients with elective surgery under general
      anesthesia from 28 hospitals or so in China. After obtaining approval from the Ethical
      Committee related to research involving human subjects,the investigators will enroll the
      patients according to the inclusion and exclusion criterion. The tympanic temperature will be
      monitored at the following time points respectively: Arriving at waiting area, entering the
      OR room, 5 min before and after anesthesia induction, every 15 min during the operation,
      after 2h the tympanic temperature will be monitored at every 30 min, Tympanic temperature
      will also be taken when the surgery complete and when patients arrived at PACU. Other
      information will also be collected including the type and dosage of anesthesia drug,duration
      of surgery and anesthesia, patient warming method，operation room temperature, the amount of
      the infusion of intravenous fluids and blood and their warming techniques during the whole
      operation procedure. The postoperative follow-up will be conducted and recorded within 30
      days after operation(for implantation surgery, the follow-up will be conducted within 90 days
      postoperatively ) which includes ICU stays, hospital stays, wound infection, new
      cardiovascular events.etc.

      The contract research organization will be delegated to do an on site monitor once a month
      (online monitor once a week) for each hospital participate the survey during the recruitment
      and perform the source data validation at the same time to review the related medical
      records,source data and the case report forms, etc.to ensure the data accuracy and
      completeness.

      Data management will be conducted through the whole survey procedure. In order to guarantee
      the validation of the data, two data managing staffs will input and verify the data
      independently.

      Statistical analysis software (SAS9.2) was used for the calculation of all the statistical
      analyses. The number of cases, mean, standard deviation, median value, maximal value and
      minimal value should be calculated for the descriptions of the qualitative parameters. Number
      of cases and percentages are used for the descriptions on the classification parameters.Two
      side test is used for all the statistical tests, P<0.05 indicates that the difference is
      statistically significant (unless indicated otherwise), and 95% confidence is used as the
      confidence interval.
observational model: Cohort
time perspective: Prospective
measure: the incidence of perioperative hypothermia
time frame: from patients entered operating room to transfering to post anesthesia care units
description: The core temperatures (tympanic membrane) will be measured at various time points to identify the occurence of hypothermia
measure: record the postoperative adverse events
time frame: From the day after operation to 30 days thereafter
description: To identify the hypothermia related adverse events, such as cardiovascular events, wound infection, hospital stays and so on.
arm group label: Observation
description: This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Yuguang Huang, doctoral
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
facility: 
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Jie YI
investigator title: Associate Professor
mesh term: Hypothermia