<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/NCT02993003</url>
  </required_header>
  <id_info>
    <org_study_id>15-1216</org_study_id>
    <nct_id>NCT02993003</nct_id>
  </id_info>
  <brief_title>Optimal Positioning of Nasopharyngeal Temperature Probes</brief_title>
  <official_title>Optimal Positioning of Nasopharyngeal Temperature Probes in Pediatric Patients: A Prospective Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Core temperature is of greatest interest in terms of temperature monitoring as it is thought&#xD;
      to represent the temperature of the vessel-rich groups that are instrumental in&#xD;
      thermoregulatory control. The nasopharynx is among the recommended temperature monitoring&#xD;
      sites for core body temperature. It is the part of the pharynx that lies above the soft&#xD;
      palate. Anteriorly it opens to the nasal cavities through the choanae; inferiorly it&#xD;
      communicates with the oropharynx through the pharyngeal isthmus. Nasopharyngeal temperatures&#xD;
      are accurate in adults when probes are inserted between 10 and 20 cm.&#xD;
&#xD;
      The optimal depth for insertion of nasopharyngeal probes remains poorly defined in infants&#xD;
      and children. While some data suggest that anthropometric measurements are well correlated&#xD;
      with endoscopic measurements in infants based on weight, the accuracy of temperature&#xD;
      measurements at these and other distances has yet to be quantified. The investigators thus&#xD;
      propose to determine the insertion depth (or range of depths) for nasopharyngeal temperature&#xD;
      proves that best approximate core temperature as measured in the distal esophagus in infants&#xD;
      and children of various sizes. The comparison site will be the distal esophagus since there&#xD;
      is broad consensus that the distal third of the esophagus it at core-body temperature.&#xD;
&#xD;
      For the two groups of infants aged up to twelve months, the nasopharyngeal probe will be&#xD;
      marked with indelible ink from 2-10 cm in 1-cm increments and inserted 10 cm. For the two&#xD;
      groups of children between 1 and 5 years, the nasopharyngeal probe will be marked with&#xD;
      indelible ink from 2-15 cm in 1.5-cm increments and inserted 10 cm. For older children, a&#xD;
      nasopharyngeal probe will be marked with indelible ink from 2 to 20 cm at 2 cm increments&#xD;
      from its tip, and inserted 20 cm.&#xD;
&#xD;
      Both nasopharyngeal and esophageal temperatures will initially be recorded 30 minutes after&#xD;
      induction of anesthesia. Nasopharyngeal probes will then be withdrawn at the designated&#xD;
      increment for each age group and will be equilibrated for 5 minutes before the temperature is&#xD;
      recorded. Thereafter, the nasopharyngeal withdrawal sequence will be repeated. The number of&#xD;
      measurement will depend on the initial depth of insertion, with measurements continuing until&#xD;
      only 2 centimeters remain in the nostril.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">November 2015</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>nasopharyngeal and esophageal temperatures</measure>
    <time_frame>up to 2 hrs during surgery</time_frame>
    <description>nasopharyngeal and esophageal temperatures at each depth</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Accuracy of Nasopharyngeal Probes</condition>
  <arm_group>
    <arm_group_label>Children between 7 months and 12 months</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>nasopharyngeal probe will be marked with indelible ink from 2-10 cm in 1-cm increments and inserted 10 cm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>children between 1 and 5 years</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>nasopharyngeal probe will be marked with indelible ink from 2-15 cm in 1.5-cm increments and inserted 10 cm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>children between 6 and 12 years</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>a nasopharyngeal probe will be marked with indelible ink from 2 to 20 cm at 2 cm increments from its tip, and inserted 20 cm</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasopharyngeal probe</intervention_name>
    <description>nasopharyngeal probe insertion</description>
    <arm_group_label>Children between 7 months and 12 months</arm_group_label>
    <arm_group_label>children between 1 and 5 years</arm_group_label>
    <arm_group_label>children between 6 and 12 years</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Elective non-cardiac surgery in children to last at least 1.5 hours;&#xD;
&#xD;
          2. Supine position anticipated;&#xD;
&#xD;
          3. General endotracheal anesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Nasopharyngeal disease (e.g. sinusitis), upper airway abnormalities, or planned oral&#xD;
             or facial surgery;&#xD;
&#xD;
          2. History of genetic or congenital anomalies leading to facial dimorphism;&#xD;
&#xD;
          3. History of recent substantive epistaxis or suspected bleeding disorder;&#xD;
&#xD;
          4. Therapeutic-dose anti-coagulation;&#xD;
&#xD;
          5. Contraindication to esophageal temperature probe insertion (i.e., esophageal varices,&#xD;
             congenital anomalies).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Months</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Daniel Sessler, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 18, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 14, 2016</study_first_posted>
  <last_update_submitted>January 23, 2018</last_update_submitted>
  <last_update_submitted_qc>January 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02993003
org study id: 15-1216
nct id: NCT02993003
lead sponsor: 
has dmc: No
Core temperature is of greatest interest in terms of temperature monitoring as it is thought
      to represent the temperature of the vessel-rich groups that are instrumental in
      thermoregulatory control. The nasopharynx is among the recommended temperature monitoring
      sites for core body temperature. It is the part of the pharynx that lies above the soft
      palate. Anteriorly it opens to the nasal cavities through the choanae; inferiorly it
      communicates with the oropharynx through the pharyngeal isthmus. Nasopharyngeal temperatures
      are accurate in adults when probes are inserted between 10 and 20 cm.

      The optimal depth for insertion of nasopharyngeal probes remains poorly defined in infants
      and children. While some data suggest that anthropometric measurements are well correlated
      with endoscopic measurements in infants based on weight, the accuracy of temperature
      measurements at these and other distances has yet to be quantified. The investigators thus
      propose to determine the insertion depth (or range of depths) for nasopharyngeal temperature
      proves that best approximate core temperature as measured in the distal esophagus in infants
      and children of various sizes. The comparison site will be the distal esophagus since there
      is broad consensus that the distal third of the esophagus it at core-body temperature.

      For the two groups of infants aged up to twelve months, the nasopharyngeal probe will be
      marked with indelible ink from 2-10 cm in 1-cm increments and inserted 10 cm. For the two
      groups of children between 1 and 5 years, the nasopharyngeal probe will be marked with
      indelible ink from 2-15 cm in 1.5-cm increments and inserted 10 cm. For older children, a
      nasopharyngeal probe will be marked with indelible ink from 2 to 20 cm at 2 cm increments
      from its tip, and inserted 20 cm.

      Both nasopharyngeal and esophageal temperatures will initially be recorded 30 minutes after
      induction of anesthesia. Nasopharyngeal probes will then be withdrawn at the designated
      increment for each age group and will be equilibrated for 5 minutes before the temperature is
      recorded. Thereafter, the nasopharyngeal withdrawal sequence will be repeated. The number of
      measurement will depend on the initial depth of insertion, with measurements continuing until
      only 2 centimeters remain in the nostril.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: nasopharyngeal and esophageal temperatures
time frame: up to 2 hrs during surgery
description: nasopharyngeal and esophageal temperatures at each depth
arm group label: Children between 7 months and 12 months
arm group type: Other
description: nasopharyngeal probe will be marked with indelible ink from 2-10 cm in 1-cm increments and inserted 10 cm
arm group label: children between 1 and 5 years
arm group type: Other
description: nasopharyngeal probe will be marked with indelible ink from 2-15 cm in 1.5-cm increments and inserted 10 cm
arm group label: children between 6 and 12 years
arm group type: Other
description: a nasopharyngeal probe will be marked with indelible ink from 2 to 20 cm at 2 cm increments from its tip, and inserted 20 cm
intervention type: Device
intervention name: Nasopharyngeal probe
description: nasopharyngeal probe insertion
arm group label: Children between 7 months and 12 months
arm group label: children between 1 and 5 years
arm group label: children between 6 and 12 years
criteria: 
gender: All
minimum age: 7 Months
maximum age: 12 Years
healthy volunteers: No
last name: Daniel Sessler, M.D.
role: Study Chair
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No