<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/NCT03770364</url>
  </required_header>
  <id_info>
    <org_study_id>2017/2298</org_study_id>
    <nct_id>NCT03770364</nct_id>
  </id_info>
  <brief_title>Peri-operative Hypothermia in Children</brief_title>
  <official_title>Peri-operative Hypothermia in Children: Improving Outcomes With Risk Prediction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KK Women's and Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KK Women's and Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to determine the incidence of hypothermia in the local paediatric population&#xD;
      in the peri-operative period, identify the risk factors involved, and thereafter develop and&#xD;
      implement clinical practice guidelines to reduce IPH such that temperature monitoring and&#xD;
      heat conservation measures can be implemented in a cost-effective way. The secondary&#xD;
      objectives are to determine the adverse outcomes of hypothermia and warming measures&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Hypothermia, defined as core body temperature less than 36 degrees Celsius, occurs&#xD;
      frequently during the course of surgery in patients across all ages, especially in the young.&#xD;
      It causes significant medical consequences including cardiac events, bleeding, surgical site&#xD;
      infection, increased shivering and patient discomfort, as well as longer hospital stays.&#xD;
      Although guidelines exist for health care providers in terms of temperature management during&#xD;
      surgery, these guidelines are not always followed as the warming measures can be costly, for&#xD;
      example, single-use temperature probes and disposable blankets, with potential risks of the&#xD;
      equipment overheating causing burns and contamination during surgery&#xD;
&#xD;
      Methodology The investigators aim to include up to 6,000 children presenting for either&#xD;
      scheduled or emergency surgeries. Core temperature before, during and after surgery using&#xD;
      routine temperature monitoring devices such as tympanic, axillary, oral, rectal and SPOTON (a&#xD;
      non-invasive method using a sticker placed on the forehead) will be measured. Other outcomes&#xD;
      collected will include cardiac arrhythmias, blood loss, hyperthermia, burn injuries,&#xD;
      shivering, discomfort, length of PACU and length of hospitalization, wound infection rates, .&#xD;
      Patients will receive the usual heat-loss prevention and warming measures.&#xD;
&#xD;
      Interim analysis of the first 2000 patients using the SPOTON method of continuous core&#xD;
      temperature monitoring will be done to determine incidence and duration of peri-operative&#xD;
      hypothermia. This monitoring modality will be compared for agreement with the conventional&#xD;
      tympanic and forehead infra-red thermoscan methods. Patient and perioperative risk factors&#xD;
      predisposing to hypothermia will be identified to guide in the formulation of clinical&#xD;
      practice guidelines tailored to the local population. Guidelines will be implemented, and&#xD;
      post-implementation incidence of IPH will be determined A pre- versus post-implementation&#xD;
      cost analysis will be carried out.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 18, 2017</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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 perioperative hypothermia</measure>
    <time_frame>From induction of anaesthesia to discharge from PACU, approximately 8 hours</time_frame>
    <description>Hypothermia is defined as Core temperature&lt;36 degrees Celsius. Incidence of hypothermia is the occurence of hypothermia, measured in percentage(%).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Duration (minutes) of perioperative hypothermia</measure>
    <time_frame>From induction of anaesthesia to discharge from PACU, approximately 8 hours</time_frame>
    <description>Hypothermia is defined as Core temperature&lt;36 degrees Celsius. Duration of hypothermia is defined as the duration of time in minutes where temperature is less than 36 degrees celsius.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of short term adverse outcomes of IPH in the paediatric population</measure>
    <time_frame>From induction of anaesthesia to discharge from PACU, approximately 8 hours</time_frame>
    <description>Short term adverse outcomes include intra-operative blood loss, arrhythmia, post-anaesthesia shivering, discomfort from cold, PACU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of long term adverse outcomes of IPH in the paediatric population</measure>
    <time_frame>From PACU discharge time up to 6 months post-surgery</time_frame>
    <description>Long term outcomes include: surgical site infection and hospitalization stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse outcomes of warming interventions in the paediatric population eg. Hyperthermia and burns injury</measure>
    <time_frame>From induction of anaesthesia to discharge from PACU, approximately 8 hours</time_frame>
    <description>Hyperthermia cTemp &gt;38 ºC, burns injury</description>
  </secondary_outcome>
  <enrollment type="Actual">4500</enrollment>
  <condition>Hypothermia Following Anesthesia, Sequela</condition>
  <condition>Pediatric ALL</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Recruitment of participants: consecutive sampling of eligible participants recruited from&#xD;
        daily operating lists in major and day surgery operating theatres&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All paediatric patients ages 16 and younger undergoing elective or emergency surgeries&#xD;
             in paediatric major and day surgical operating theaters in KK women's and Children's&#xD;
             Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing operative procedures under local anaesthesia&#xD;
&#xD;
          -  Patients with impaired temperature control e.g., severe head injury, febrile illness&#xD;
&#xD;
          -  Patients who are admitted to intensive care unit (ICU) post-operatively.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shu Ying Lee, FANZCA, Mmed</last_name>
    <role>Principal Investigator</role>
    <affiliation>KK Women's and Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KK Women's and Children's Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>229899</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 27, 2017</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>September 25, 2020</last_update_submitted>
  <last_update_submitted_qc>September 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  </patient_data>
  <!-- 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/NCT03770364
org study id: 2017/2298
nct id: NCT03770364
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to determine the incidence of hypothermia in the local paediatric population
      in the peri-operative period, identify the risk factors involved, and thereafter develop and
      implement clinical practice guidelines to reduce IPH such that temperature monitoring and
      heat conservation measures can be implemented in a cost-effective way. The secondary
      objectives are to determine the adverse outcomes of hypothermia and warming measures
Background Hypothermia, defined as core body temperature less than 36 degrees Celsius, occurs
      frequently during the course of surgery in patients across all ages, especially in the young.
      It causes significant medical consequences including cardiac events, bleeding, surgical site
      infection, increased shivering and patient discomfort, as well as longer hospital stays.
      Although guidelines exist for health care providers in terms of temperature management during
      surgery, these guidelines are not always followed as the warming measures can be costly, for
      example, single-use temperature probes and disposable blankets, with potential risks of the
      equipment overheating causing burns and contamination during surgery

      Methodology The investigators aim to include up to 6,000 children presenting for either
      scheduled or emergency surgeries. Core temperature before, during and after surgery using
      routine temperature monitoring devices such as tympanic, axillary, oral, rectal and SPOTON (a
      non-invasive method using a sticker placed on the forehead) will be measured. Other outcomes
      collected will include cardiac arrhythmias, blood loss, hyperthermia, burn injuries,
      shivering, discomfort, length of PACU and length of hospitalization, wound infection rates, .
      Patients will receive the usual heat-loss prevention and warming measures.

      Interim analysis of the first 2000 patients using the SPOTON method of continuous core
      temperature monitoring will be done to determine incidence and duration of peri-operative
      hypothermia. This monitoring modality will be compared for agreement with the conventional
      tympanic and forehead infra-red thermoscan methods. Patient and perioperative risk factors
      predisposing to hypothermia will be identified to guide in the formulation of clinical
      practice guidelines tailored to the local population. Guidelines will be implemented, and
      post-implementation incidence of IPH will be determined A pre- versus post-implementation
      cost analysis will be carried out.
observational model: Cohort
time perspective: Prospective
measure: Incidence (%) of perioperative hypothermia
time frame: From induction of anaesthesia to discharge from PACU, approximately 8 hours
description: Hypothermia is defined as Core temperature<36 degrees Celsius. Incidence of hypothermia is the occurence of hypothermia, measured in percentage(%).
measure: Duration (minutes) of perioperative hypothermia
time frame: From induction of anaesthesia to discharge from PACU, approximately 8 hours
description: Hypothermia is defined as Core temperature<36 degrees Celsius. Duration of hypothermia is defined as the duration of time in minutes where temperature is less than 36 degrees celsius.
measure: Incidence of short term adverse outcomes of IPH in the paediatric population
time frame: From induction of anaesthesia to discharge from PACU, approximately 8 hours
description: Short term adverse outcomes include intra-operative blood loss, arrhythmia, post-anaesthesia shivering, discomfort from cold, PACU stay
measure: Incidence of long term adverse outcomes of IPH in the paediatric population
time frame: From PACU discharge time up to 6 months post-surgery
description: Long term outcomes include: surgical site infection and hospitalization stay
measure: Incidence of adverse outcomes of warming interventions in the paediatric population eg. Hyperthermia and burns injury
time frame: From induction of anaesthesia to discharge from PACU, approximately 8 hours
description: Hyperthermia cTemp >38 ºC, burns injury
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Years
healthy volunteers: No
last name: Shu Ying Lee, FANZCA, Mmed
role: Principal Investigator
affiliation: KK Women's and Children's Hospital
facility: 
country: Singapore
responsible party type: Sponsor
mesh term: Hypothermia
sharing ipd: Undecided