<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/NCT03820232</url>
  </required_header>
  <id_info>
    <org_study_id>11994_spe</org_study_id>
    <nct_id>NCT03820232</nct_id>
  </id_info>
  <brief_title>Intraoperative Body Core Temperature Monitoring: Oesophageal Probe vs Heated Controlled Servo Sensor</brief_title>
  <acronym>ESOSPOT</acronym>
  <official_title>Intraoperative Body Core Temperature Monitoring in Patients Undergoing Major Abdominal Surgery: Comparison Between the Oesophageal Probe and the Heated Controlled Servo Sensor</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Careggi Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Careggi Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Monitoring of intraoperative core temperature is essential for patient safety, reducing the&#xD;
      risk of perioperative hypothermia. A recently developed measuring system, SpotOn® (3M, St.&#xD;
      Paul, MN), measures the core temperature in a non-invasive manner. Its accuracy in patients&#xD;
      undergoing general surgery has not been investigated yet. The study was aimed at comparing&#xD;
      the accuracy of the SpotOn® in comparison with the oesophageal probe which is considered the&#xD;
      current standard in our care units.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Monitoring of intraoperative core temperature is essential for patient safety, reducing the&#xD;
      risk of perioperative hypothermia. A recently developed measuring system, SpotOn® (3M, St.&#xD;
      Paul, MN), measures the core temperature in a non-invasive manner. Its accuracy in patients&#xD;
      undergoing general surgery has not been investigated yet. The study was aimed at comparing&#xD;
      the accuracy of the SpotOn® in comparison with the oesophageal probe which is considered the&#xD;
      current standard in our care units. In this study, patients who were candidates for major or&#xD;
      urological surgery will be considered eligible for enrollment. The core body temperature will&#xD;
      be thus measured with both a single-use oesophageal probe and a SpotOn® heated controlled&#xD;
      servo sensor.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2018</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 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>accuracy of heated controlled servo sensor in monitoring body core temperature compared with oesophageal probe</measure>
    <time_frame>1 hour after the induction of general anesthesia</time_frame>
    <description>Difference between temperature measured with heated controlled servo sensor and oesophageal probe</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Surgery</condition>
  <condition>Temperature Change, Body</condition>
  <arm_group>
    <arm_group_label>Surgical patients</arm_group_label>
    <description>Patients who were candidates for major or urological surgery under general anaesthesia will be observed. In particular, the core body temperature will be measured with both a single-use oesophageal probe and a SpotOn® heated controlled servo sensor.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>temperature monitoring</intervention_name>
    <description>In every patient observed in this prospective observational study, body core temperature will be contemporaneously monitored through the oesophageal probe and the heated controlled servo sensor. Both are routinely used for this purpose in clinical practice</description>
    <arm_group_label>Surgical patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who were candidates for major or urological surgery were considered eligible to be&#xD;
        enrolled. The core body temperature was measured with both a single-use oesophageal probe&#xD;
        and a SpotOn® heated controlled servo sensor.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age&gt;18 years&#xD;
&#xD;
          -  patients scheduled for major abdominal surgery&#xD;
&#xD;
          -  patients scheduled for general anesthesia&#xD;
&#xD;
          -  expected surgery duration longer than 30 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  skin infection in the forehead&#xD;
&#xD;
          -  upper airway anatomy alterations&#xD;
&#xD;
          -  pre-existing oesophageal disease&#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>Gianluca Villa</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Careggi</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Careggi</name>
      <address>
        <city>Florence</city>
        <zip>50100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>August 29, 2023</last_update_submitted>
  <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Careggi Hospital</investigator_affiliation>
    <investigator_full_name>Gianluca Villa</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Intraoperative, Hypothermia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Body Temperature Changes</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03820232
org study id: 11994_spe
nct id: NCT03820232
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Monitoring of intraoperative core temperature is essential for patient safety, reducing the
      risk of perioperative hypothermia. A recently developed measuring system, SpotOn® (3M, St.
      Paul, MN), measures the core temperature in a non-invasive manner. Its accuracy in patients
      undergoing general surgery has not been investigated yet. The study was aimed at comparing
      the accuracy of the SpotOn® in comparison with the oesophageal probe which is considered the
      current standard in our care units.
Monitoring of intraoperative core temperature is essential for patient safety, reducing the
      risk of perioperative hypothermia. A recently developed measuring system, SpotOn® (3M, St.
      Paul, MN), measures the core temperature in a non-invasive manner. Its accuracy in patients
      undergoing general surgery has not been investigated yet. The study was aimed at comparing
      the accuracy of the SpotOn® in comparison with the oesophageal probe which is considered the
      current standard in our care units. In this study, patients who were candidates for major or
      urological surgery will be considered eligible for enrollment. The core body temperature will
      be thus measured with both a single-use oesophageal probe and a SpotOn® heated controlled
      servo sensor.
observational model: Cohort
time perspective: Prospective
measure: accuracy of heated controlled servo sensor in monitoring body core temperature compared with oesophageal probe
time frame: 1 hour after the induction of general anesthesia
description: Difference between temperature measured with heated controlled servo sensor and oesophageal probe
arm group label: Surgical patients
description: Patients who were candidates for major or urological surgery under general anaesthesia will be observed. In particular, the core body temperature will be measured with both a single-use oesophageal probe and a SpotOn® heated controlled servo sensor.
intervention type: Device
intervention name: temperature monitoring
description: In every patient observed in this prospective observational study, body core temperature will be contemporaneously monitored through the oesophageal probe and the heated controlled servo sensor. Both are routinely used for this purpose in clinical practice
arm group label: Surgical patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gianluca Villa
role: Principal Investigator
affiliation: Azienda Careggi
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Careggi Hospital
investigator full name: Gianluca Villa
investigator title: Principal investigator
mesh term: Body Temperature Changes
sharing ipd: No