<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/NCT02225743</url>
  </required_header>
  <id_info>
    <org_study_id>Thermoregulation Total Joint</org_study_id>
    <secondary_id>Pro00035290</secondary_id>
    <nct_id>NCT02225743</nct_id>
  </id_info>
  <brief_title>Observational Examination of Thermoregulation in Total Joint Arthroplasty</brief_title>
  <official_title>Observational Examination of Thermoregulation in Total Joint Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Total joint patients have poor outcomes with infection since they are having permanent&#xD;
      hardware implanted. Infection prevention in this group is therefore critical and a major&#xD;
      source of discussion in both the orthopedic and anesthesia literature.&#xD;
&#xD;
      Hypothermia has been shown to increase the risk of infection and blood loss. However, studies&#xD;
      have not examined when in the operation or how fast patients temperatures drop. This study&#xD;
      will observe how patients' temperatures change during total joint arthroplasty. By&#xD;
      identifying when body temperature changes occur, prevention strategies may be developed and&#xD;
      implemented.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peri-operative hypothermia can have deleterious effects. While there is no standard&#xD;
      consistent definition within the literature mild hypothermia is commonly defined as a core&#xD;
      temperature between 34 and 36 °C. Mild hypothermia has been shown to increase the occurrence&#xD;
      of surgical site infections, cardiac morbidity, coagulopathy leading to increased blood loss&#xD;
      and transfusion requirements, impaired drug metabolism, and prolonged emergence from&#xD;
      anesthesia. In addition, there is evidence that maintaining intra-operative normothermia can&#xD;
      shorten hospital length of stay. Despite the fact that intra-operative temperature monitoring&#xD;
      and warming are considered standard of care, peri-operative hypothermia in total joint&#xD;
      arthroplasty patients remains an issue for several reasons. A large proportion of patient&#xD;
      undergoing joint replacement are elderly, making them susceptible to peri-operative&#xD;
      hypothermia. In addition, regional anesthesia causes vasodilation and promotes heat flow from&#xD;
      the core to the periphery and impairs central and autonomic thermoregulation such that&#xD;
      patients receiving neuraxial anesthesia can be particularly susceptible to perioperative&#xD;
      hypothermia. Finally, core temperature monitoring is typically not used during regional&#xD;
      anesthesia and hypothermia may go undetected for long periods of time.&#xD;
&#xD;
      The primary goal of this study was to examine the incidence of hypothermia during lower&#xD;
      extremity arthroplasty. A secondary aim was to identify patient and operative factors&#xD;
      associated with hypothermia in order to improve future preventative strategies. Our&#xD;
      hypothesis was that peri-operative hypothermia occurs in the majority of patients undergoing&#xD;
      lower extremity arthroplasty. In addition, we hypothesized that certain patient and&#xD;
      anesthetic factors (such as low body mass index and receiving general anesthesia) would&#xD;
      increase the incidence of hypothermia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Incidence of Hypothermia</measure>
    <time_frame>Starting with temperature measurement prior to leaving preoperative holding for OR and ending after temperature taken on arrival in recovery room</time_frame>
    <description>The incidence of ever being hypothermic (temperature &lt; 36.0 °C at one or more measurements) was the primary outcome. All temperatures were assessed with an Exergen temporal thermometer (precise to 0.1 °C). Each temporal measurement was taken and recorded three times for accuracy and the mean value utilized for data analysis at each time point. Temperatures were measured upon (1) leaving holding area; (2) operating room (OR) arrival; (3) after anesthetic induction; (4) upper body forced air warmer initiation (used for all patients); (5) incision; (6-8) every 30 minutes after incision; (9) leaving the OR; and (10) arrival to PACU. OR temperature and humidity were recorded throughout.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">120</enrollment>
  <condition>Hypothermia</condition>
  <arm_group>
    <arm_group_label>Joint Arthroplasty</arm_group_label>
    <description>Participants undergoing joint replacement</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation Of Temperature</intervention_name>
    <description>Participants temperature will be recorded perioperatively.</description>
    <arm_group_label>Joint Arthroplasty</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults 18 years or older that are having a total joint replacement surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults 18 years of age and over that are scheduled to undergo total hip or total knee&#xD;
             joint arthroplasty.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients unable to give informed consent will be excluded.&#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>Sylvia H Wilson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wanda Jones</last_name>
    <role>Study Director</role>
    <affiliation>Medical University of South Carolina</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kurz A. Thermal care in the perioperative period. Best Pract Res Clin Anaesthesiol. 2008 Mar;22(1):39-62. doi: 10.1016/j.bpa.2007.10.004.</citation>
    <PMID>18494388</PMID>
  </reference>
  <reference>
    <citation>Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. Study of Wound Infection and Temperature Group. N Engl J Med. 1996 May 9;334(19):1209-15. doi: 10.1056/NEJM199605093341901.</citation>
    <PMID>8606715</PMID>
  </reference>
  <reference>
    <citation>Seamon MJ, Wobb J, Gaughan JP, Kulp H, Kamel I, Dempsey DT. The effects of intraoperative hypothermia on surgical site infection: an analysis of 524 trauma laparotomies. Ann Surg. 2012 Apr;255(4):789-95. doi: 10.1097/SLA.0b013e31824b7e35.</citation>
    <PMID>22388109</PMID>
  </reference>
  <reference>
    <citation>Sun Z, Honar H, Sessler DI, Dalton JE, Yang D, Panjasawatwong K, Deroee AF, Salmasi V, Saager L, Kurz A. Intraoperative core temperature patterns, transfusion requirement, and hospital duration in patients warmed with forced air. Anesthesiology. 2015 Feb;122(2):276-85. doi: 10.1097/ALN.0000000000000551.</citation>
    <PMID>25603202</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <results_first_submitted>July 25, 2018</results_first_submitted>
  <results_first_submitted_qc>January 18, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 24, 2019</results_first_posted>
  <last_update_submitted>January 18, 2019</last_update_submitted>
  <last_update_submitted_qc>January 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Hypothermia</keyword>
  <keyword>Total Hip Joint Prosthesis</keyword>
  <keyword>Total Knee Joint Prosthesis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypothermia</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Joint Arthroplasty</title>
          <description>Participants undergoing joint replacement&#xD;
Observation Of Temperature: Participants temperature will be recorded perioperatively.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="102">18 patients chose not to participate on the day of surgery.</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Joint Arthroplasty</title>
          <description>Participants undergoing joint replacement&#xD;
Observation Of Temperature: Participants temperature will be recorded perioperatively.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="102"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.5" spread="11.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total Knee Arthroplasty</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Incidence of Hypothermia</title>
        <description>The incidence of ever being hypothermic (temperature &lt; 36.0 °C at one or more measurements) was the primary outcome. All temperatures were assessed with an Exergen temporal thermometer (precise to 0.1 °C). Each temporal measurement was taken and recorded three times for accuracy and the mean value utilized for data analysis at each time point. Temperatures were measured upon (1) leaving holding area; (2) operating room (OR) arrival; (3) after anesthetic induction; (4) upper body forced air warmer initiation (used for all patients); (5) incision; (6-8) every 30 minutes after incision; (9) leaving the OR; and (10) arrival to PACU. OR temperature and humidity were recorded throughout.</description>
        <time_frame>Starting with temperature measurement prior to leaving preoperative holding for OR and ending after temperature taken on arrival in recovery room</time_frame>
        <population>Ever hypothermic (temperature &lt;36.0 degrees C) during the perioperative period</population>
        <group_list>
          <group group_id="O1">
            <title>Hypothermia</title>
            <description>Hypothermia was defined as a temperature less than 36.0 °C. .</description>
          </group>
        </group_list>
        <measure>
          <title>Incidence of Hypothermia</title>
          <description>The incidence of ever being hypothermic (temperature &lt; 36.0 °C at one or more measurements) was the primary outcome. All temperatures were assessed with an Exergen temporal thermometer (precise to 0.1 °C). Each temporal measurement was taken and recorded three times for accuracy and the mean value utilized for data analysis at each time point. Temperatures were measured upon (1) leaving holding area; (2) operating room (OR) arrival; (3) after anesthetic induction; (4) upper body forced air warmer initiation (used for all patients); (5) incision; (6-8) every 30 minutes after incision; (9) leaving the OR; and (10) arrival to PACU. OR temperature and humidity were recorded throughout.</description>
          <population>Ever hypothermic (temperature &lt;36.0 degrees C) during the perioperative period</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Joint Arthroplasty</title>
          <description>Participants undergoing joint replacement&#xD;
Observation Of Temperature: Participants temperature will be recorded perioperatively.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="102"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sylvia Wilson, MD</name_or_title>
      <organization>Medical University of South Carolina</organization>
      <phone>843-792-2322</phone>
      <email>wilsosh@musc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02225743
org study id: Thermoregulation Total Joint
secondary id: Pro00035290
nct id: NCT02225743
lead sponsor: 
has dmc: No
Total joint patients have poor outcomes with infection since they are having permanent
      hardware implanted. Infection prevention in this group is therefore critical and a major
      source of discussion in both the orthopedic and anesthesia literature.

      Hypothermia has been shown to increase the risk of infection and blood loss. However, studies
      have not examined when in the operation or how fast patients temperatures drop. This study
      will observe how patients' temperatures change during total joint arthroplasty. By
      identifying when body temperature changes occur, prevention strategies may be developed and
      implemented.
Peri-operative hypothermia can have deleterious effects. While there is no standard
      consistent definition within the literature mild hypothermia is commonly defined as a core
      temperature between 34 and 36 °C. Mild hypothermia has been shown to increase the occurrence
      of surgical site infections, cardiac morbidity, coagulopathy leading to increased blood loss
      and transfusion requirements, impaired drug metabolism, and prolonged emergence from
      anesthesia. In addition, there is evidence that maintaining intra-operative normothermia can
      shorten hospital length of stay. Despite the fact that intra-operative temperature monitoring
      and warming are considered standard of care, peri-operative hypothermia in total joint
      arthroplasty patients remains an issue for several reasons. A large proportion of patient
      undergoing joint replacement are elderly, making them susceptible to peri-operative
      hypothermia. In addition, regional anesthesia causes vasodilation and promotes heat flow from
      the core to the periphery and impairs central and autonomic thermoregulation such that
      patients receiving neuraxial anesthesia can be particularly susceptible to perioperative
      hypothermia. Finally, core temperature monitoring is typically not used during regional
      anesthesia and hypothermia may go undetected for long periods of time.

      The primary goal of this study was to examine the incidence of hypothermia during lower
      extremity arthroplasty. A secondary aim was to identify patient and operative factors
      associated with hypothermia in order to improve future preventative strategies. Our
      hypothesis was that peri-operative hypothermia occurs in the majority of patients undergoing
      lower extremity arthroplasty. In addition, we hypothesized that certain patient and
      anesthetic factors (such as low body mass index and receiving general anesthesia) would
      increase the incidence of hypothermia.
observational model: Case-Only
time perspective: Prospective
measure: Incidence of Hypothermia
time frame: Starting with temperature measurement prior to leaving preoperative holding for OR and ending after temperature taken on arrival in recovery room
description: The incidence of ever being hypothermic (temperature < 36.0 °C at one or more measurements) was the primary outcome. All temperatures were assessed with an Exergen temporal thermometer (precise to 0.1 °C). Each temporal measurement was taken and recorded three times for accuracy and the mean value utilized for data analysis at each time point. Temperatures were measured upon (1) leaving holding area; (2) operating room (OR) arrival; (3) after anesthetic induction; (4) upper body forced air warmer initiation (used for all patients); (5) incision; (6-8) every 30 minutes after incision; (9) leaving the OR; and (10) arrival to PACU. OR temperature and humidity were recorded throughout.
arm group label: Joint Arthroplasty
description: Participants undergoing joint replacement
intervention type: Other
intervention name: Observation Of Temperature
description: Participants temperature will be recorded perioperatively.
arm group label: Joint Arthroplasty
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sylvia H Wilson, MD
role: Principal Investigator
affiliation: Medical University of South Carolina
last name: Wanda Jones
role: Study Director
affiliation: Medical University of South Carolina
facility: 
country: United States
citation: Kurz A. Thermal care in the perioperative period. Best Pract Res Clin Anaesthesiol. 2008 Mar;22(1):39-62. doi: 10.1016/j.bpa.2007.10.004.
PMID: 18494388
citation: Kurz A, Sessler DI, Lenhardt R. Perioperative normothermia to reduce the incidence of surgical-wound infection and shorten hospitalization. Study of Wound Infection and Temperature Group. N Engl J Med. 1996 May 9;334(19):1209-15. doi: 10.1056/NEJM199605093341901.
PMID: 8606715
citation: Seamon MJ, Wobb J, Gaughan JP, Kulp H, Kamel I, Dempsey DT. The effects of intraoperative hypothermia on surgical site infection: an analysis of 524 trauma laparotomies. Ann Surg. 2012 Apr;255(4):789-95. doi: 10.1097/SLA.0b013e31824b7e35.
PMID: 22388109
citation: Sun Z, Honar H, Sessler DI, Dalton JE, Yang D, Panjasawatwong K, Deroee AF, Salmasi V, Saager L, Kurz A. Intraoperative core temperature patterns, transfusion requirement, and hospital duration in patients warmed with forced air. Anesthesiology. 2015 Feb;122(2):276-85. doi: 10.1097/ALN.0000000000000551.
PMID: 25603202
responsible party type: Sponsor
mesh term: Hypothermia
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 