<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/NCT02201628</url>
  </required_header>
  <id_info>
    <org_study_id>14SG04</org_study_id>
    <nct_id>NCT02201628</nct_id>
  </id_info>
  <brief_title>Correlation of Nasopharyngeal (NP) and Lower Oesophageal (LO) Temperatures in Ventilated Children</brief_title>
  <official_title>Comparison of Nasopharyngeal and Lower Oesophageal Temperatures Under General Anaesthesia With an Endotracheal Tube With Leak</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Great Ormond Street Hospital for Children NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Great Ormond Street Hospital for Children NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children lose heat under general anaesthesia, thus temperature is routinely monitored during&#xD;
      anaesthesia for all but the shortest cases, and active warming can be used to prevent&#xD;
      hypothermia and its resulting complications. Temperature can be measured at several sites&#xD;
      dependent on the type of surgery and patient factors. Previously a temperature probe has been&#xD;
      sited in the lower third of the oesophagus (swallowing tube) but it is difficult to&#xD;
      accurately place this without an X-Ray. Consequently it is more common to use a temperature&#xD;
      probe placed in the nasopharynx (where the nose and throat meet), when the child is&#xD;
      anaesthetised.&#xD;
&#xD;
      However the investigators do not know if the temperature in the nasopharynx correlates well&#xD;
      with the real core temperature or not.This prospective, unblinded, agreement study will seek&#xD;
      to find an agreement of 2 methods to measure temperature in children undergoing general&#xD;
      anaesthesia with a breathing tube that has a leak.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is known that temperature in the lower third of the oesophagus correlates well with the&#xD;
      gold standard of core temperature measurement, namely the temperature of blood in the heart.&#xD;
      It is not known if oesophageal and nasopharyngeal temperatures correlate in children on a&#xD;
      breathing machine via a tube with leak. If this study were to find a good correlation between&#xD;
      oesophageal and nasopharyngeal temperature, this would allow clinicians to confidently use&#xD;
      the more feasible nasopharyngeal temperature probes.&#xD;
&#xD;
      For this study 100 children will have both nasopharyngeal and oesophageal temperatures&#xD;
      measured during general anaesthesia, both in the presence and absence of a leak around the&#xD;
      endotracheal tube.&#xD;
&#xD;
      It is hypothesised that even in the presence of a leak, the temperature difference between&#xD;
      the two methods will be less than 0.5 degrees centigrade.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 25, 2014</start_date>
  <completion_date type="Actual">December 16, 2014</completion_date>
  <primary_completion_date type="Actual">December 16, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Temperature Difference (in Degrees Celsius) Between 2 Body Sites in Children Undergoing General Anaesthesia. The 2 Sites Are: (1) Lower Oesophagus; (2) Nasopharynx</measure>
    <time_frame>6 months</time_frame>
    <description>Temperature will be measured in the lower oesophagus of a child ventilated with a cuffed Endotracheal Tube (ETT). Readings will be recorded when there is no leak (cuff up) and when there is a clinically determinable, soft, audible leak (cuff down) around the ETT. Simultaneously temperature will also be measured in the nasopharynx.&#xD;
This will occur during general anaesthesia for a procedure that entails the performance of a radiograph (X-Ray) of the chest. The X-Ray will be used by the investigators to confirm correct placement of the temperature probe in the lower third of the oesophagus. We aim to show that the temperature measured in the lower oesophagus is the same or does not significantly differ from the temperature in the nasopharynx, even in the presence of a leak around the ETT. Temperature differences in degrees celsius will be reported.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Temperature Difference in the Presence of a Small Leak (Fractional Volume Loss &lt; 21%) and Large Leak (Fractional Volume Loss &gt; 21%)</measure>
    <time_frame>6 months</time_frame>
    <description>Sub-group analysis: Fractional Volume Loss (FVL) will be determined using spirometry readings taken during temperature measurements.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Child</condition>
  <arm_group>
    <arm_group_label>Nasopharyngeal and oesophageal temperatures</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>An oesophageal and nasopharyngeal temperature probe will be placed and temperature will be measured at these site</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasopharyngeal and oesophageal temperature probes</intervention_name>
    <arm_group_label>Nasopharyngeal and oesophageal temperatures</arm_group_label>
    <other_name>Covidien</other_name>
    <other_name>Mon-a-therm™ General Purpose Temperature Probe 400TM</other_name>
    <other_name>90050</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient requires general anaesthesia with endotracheal intubation for a procedure&#xD;
             assisted by radiography (e.g. line insertion, line change).&#xD;
&#xD;
          -  Patient requires chest radiograph for procedure.&#xD;
&#xD;
          -  Expected anaesthetic time more than 30 minutes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No written parental written consent.&#xD;
&#xD;
          -  Known oesophageal pathology (e.g. tracheo-oesophageal fistula, oesophageal strictures,&#xD;
             oesophageal varices, oesophageal atresia).&#xD;
&#xD;
          -  Known base of skull or midface fractures.&#xD;
&#xD;
          -  Previous gastric bypass surgery or nasal surgery.&#xD;
&#xD;
          -  Known coagulopathy.&#xD;
&#xD;
          -  Previous alkaline ingestion.&#xD;
&#xD;
          -  High aspiration risk.&#xD;
&#xD;
          -  Significant respiratory co-morbidity requiring anticipated peak airway pressures &gt; 25&#xD;
             cm of water&#xD;
&#xD;
          -  American Society Anaesthesiologists (ASA) grading 4 - 5.&#xD;
&#xD;
          -  Tracheostomy in situ.&#xD;
&#xD;
          -  Severe sepsis or septic shock or other other condition (such as bronchopulmonary&#xD;
             fistula) that precludes use of tidal volume ventilation over 7 ml/kg.&#xD;
&#xD;
          -  Known airway abnormalities (e.g. subglottic stenosis) that preclude placement of a&#xD;
             MicroCuff® endotracheal tube.&#xD;
&#xD;
          -  Oesophageal or nasopharyngeal probe contraindicated for reasons related to surgery /&#xD;
             procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Months</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aarjan P Snoek, MBChB, FRCA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Great Ormond Street Hospital for Children NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Helen V Hume-Smith, MBBS, FRCA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Great Ormond Street Hospital for Children NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emily Haberman, MBBS, FRCA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Great Ormond Street Hospital for Children NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Great Ormond Street Hospital for Children NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <zip>WC1N 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://anestesiar.org/WP/uploads/2012/04/Microcuff-Paed-Endo-Tube.pdf</url>
    <description>Kimberly-Clark. Important MicroCuff® Paediatric Endotracheal Tube Points to Remember</description>
  </link>
  <link>
    <url>https://www.nice.org.uk/guidance/cg65/update/CG65/documents/perioperative-hypothermia-inadvertent-guideline-full-guideline-part-12</url>
    <description>National Institute for Health and Clinical Excellence. The management of inadvertent perioperative hypothermia in adults: full guideline</description>
  </link>
  <reference>
    <citation>Torossian A. Thermal management during anaesthesia and thermoregulation standards for the prevention of inadvertent perioperative hypothermia. Best Pract Res Clin Anaesthesiol. 2008 Dec;22(4):659-68. doi: 10.1016/j.bpa.2008.07.006.</citation>
    <PMID>19137809</PMID>
  </reference>
  <reference>
    <citation>Sessler DI. Complications and treatment of mild hypothermia. Anesthesiology. 2001 Aug;95(2):531-43. doi: 10.1097/00000542-200108000-00040. No abstract available.</citation>
    <PMID>11506130</PMID>
  </reference>
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    <citation>Evans DC, Doraiswamy VA, Prosciak MP, Silviera M, Seamon MJ, Rodriguez Funes V, Cipolla J, Wang CF, Kavuturu S, Torigian DA, Cook CH, Lindsey DE, Steinberg SM, Stawicki SP. Complications associated with pulmonary artery catheters: a comprehensive clinical review. Scand J Surg. 2009;98(4):199-208. doi: 10.1177/145749690909800402.</citation>
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    <citation>Robinson JL, Seal RF, Spady DW, Joffres MR. Comparison of esophageal, rectal, axillary, bladder, tympanic, and pulmonary artery temperatures in children. J Pediatr. 1998 Oct;133(4):553-6. doi: 10.1016/s0022-3476(98)70067-8.</citation>
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    <citation>SEVERINGHAUS JW, STUPFEL M. Internal body temperature gradients during anesthesia and hypothermia and effect of vagotomy. J Appl Physiol. 1956 Nov;9(3):380-6. doi: 10.1152/jappl.1956.9.3.380. No abstract available.</citation>
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    <citation>Holtzclaw BJ. Monitoring body temperature. AACN Clin Issues Crit Care Nurs. 1993 Feb;4(1):44-55.</citation>
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    <citation>Stone JG, Young WL, Smith CR, Solomon RA, Wald A, Ostapkovich N, Shrebnick DB. Do standard monitoring sites reflect true brain temperature when profound hypothermia is rapidly induced and reversed? Anesthesiology. 1995 Feb;82(2):344-51. doi: 10.1097/00000542-199502000-00004.</citation>
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    <citation>Maxton FJ, Justin L, Gillies D. Estimating core temperature in infants and children after cardiac surgery: a comparison of six methods. J Adv Nurs. 2004 Jan;45(2):214-22. doi: 10.1046/j.1365-2648.2003.02883.x.</citation>
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    <citation>Whitby JD, Dunkin LJ. Cerebral, oesophageal and nasopharyngeal temperatures. Br J Anaesth. 1971 Jul;43(7):673-6. doi: 10.1093/bja/43.7.673. No abstract available.</citation>
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    <citation>Litman RS, Maxwell LG. Cuffed versus uncuffed endotracheal tubes in pediatric anesthesia: the debate should finally end. Anesthesiology. 2013 Mar;118(3):500-1. doi: 10.1097/ALN.0b013e318282cc8f. No abstract available.</citation>
    <PMID>23314108</PMID>
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    <citation>Strobel CT, Byrne WJ, Ament ME, Euler AR. Correlation of esophageal lengths in children with height: application to the Tuttle test without prior esophageal manometry. J Pediatr. 1979 Jan;94(1):81-4. doi: 10.1016/s0022-3476(79)80361-3. No abstract available.</citation>
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    <citation>Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.</citation>
    <PMID>18648241</PMID>
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    <citation>Ramsay JG, Ralley FE, Whalley DG, DelliColli P, Wynands JE. Site of temperature monitoring and prediction of afterdrop after open heart surgery. Can Anaesth Soc J. 1985 Nov;32(6):607-12. doi: 10.1007/BF03011406.</citation>
    <PMID>3878219</PMID>
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    <citation>Cronin K, Wallis M. Temperature taking in the ICU: which route is best? Aust Crit Care. 2000 May;13(2):59-64. doi: 10.1016/s1036-7314(00)70623-0.</citation>
    <PMID>11235453</PMID>
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    <citation>Ko HK, Flemmer A, Haberl C, Simbruner G. Methodological investigation of measuring nasopharyngeal temperature as noninvasive brain temperature analogue in the neonate. Intensive Care Med. 2001 Apr;27(4):736-42. doi: 10.1007/s001340000829.</citation>
    <PMID>11398702</PMID>
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    <citation>Muravchick S. Deep body thermometry during general anesthesia. Anesthesiology. 1983 Mar;58(3):271-5. doi: 10.1097/00000542-198303000-00014. No abstract available.</citation>
    <PMID>6829963</PMID>
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    <citation>Wass CT, Long TR, Deschamps C. Entrapment of a nasopharyngeal temperature probe: an unusual complication during an apparently uneventful elective revision laparoscopic Nissen fundoplication. Dis Esophagus. 2010 Jan;23(1):33-5. doi: 10.1111/j.1442-2050.2009.00968.x. Epub 2009 Apr 15.</citation>
    <PMID>19392849</PMID>
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    <citation>Williams DJ, Kelleher AA. Defective nasopharyngeal temperature probes. Anaesthesia. 2002 Dec;57(12):1223; author reply 1223-4. doi: 10.1046/j.1365-2044.2002.02913_18.x. No abstract available.</citation>
    <PMID>12437729</PMID>
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    <PMID>23061742</PMID>
  </reference>
  <results_reference>
    <citation>Whitby JD, Dunkin LJ. Temperature differences in the oesophagus. The effects of intubation and ventilation. Br J Anaesth. 1969 Jul;41(7):615-8. doi: 10.1093/bja/41.7.615. No abstract available.</citation>
    <PMID>5798841</PMID>
  </results_reference>
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    <citation>Bloch EC, Ginsberg B, Binner RA Jr. The esophageal temperature gradient in anesthetized children. J Clin Monit. 1993 Apr;9(2):73-7. doi: 10.1007/BF01616917.</citation>
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  </results_reference>
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    <citation>Mekjavic IB, Rempel ME. Determination of esophageal probe insertion length based on standing and sitting height. J Appl Physiol (1985). 1990 Jul;69(1):376-9. doi: 10.1152/jappl.1990.69.1.376.</citation>
    <PMID>2394660</PMID>
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    <citation>Taylor C, Subaiya L, Corsino D. Pediatric cuffed endotracheal tubes: an evolution of care. Ochsner J. 2011 Spring;11(1):52-6.</citation>
    <PMID>21603336</PMID>
  </results_reference>
  <results_reference>
    <citation>Matsukawa T, Ozaki M, Sessler DI, Nishiyama T, Imamura M, Kumazawa T. Accuracy and precision of &quot;deep sternal&quot; and tracheal temperatures at high- and low-fresh-gas flows. Br J Anaesth. 1998 Aug;81(2):171-5. doi: 10.1093/bja/81.2.171.</citation>
    <PMID>9813517</PMID>
  </results_reference>
  <results_reference>
    <citation>Weiss M, Dullenkopf A, Fischer JE, Keller C, Gerber AC; European Paediatric Endotracheal Intubation Study Group. Prospective randomized controlled multi-centre trial of cuffed or uncuffed endotracheal tubes in small children. Br J Anaesth. 2009 Dec;103(6):867-73. doi: 10.1093/bja/aep290. Epub 2009 Nov 3.</citation>
    <PMID>19887533</PMID>
  </results_reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 28, 2014</study_first_posted>
  <results_first_submitted>January 13, 2022</results_first_submitted>
  <results_first_submitted_qc>April 29, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">January 26, 2023</results_first_posted>
  <last_update_submitted>April 29, 2022</last_update_submitted>
  <last_update_submitted_qc>April 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oesophageal</keyword>
  <keyword>Nasopharyngeal</keyword>
  <keyword>temperature</keyword>
  <keyword>Intubation, endotracheal</keyword>
  <keyword>Pediatric</keyword>
  <keyword>Anesthesia</keyword>
  <keyword>Hypothermia</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 18, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT02201628/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 24, 2014</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT02201628/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>9 were excluded due to incomplete data or insufficient FVL difference between cuff down and cuff up scenarios</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cuff Inflation and Cuff Deflation Groups</title>
          <description>Cuff deflation to achieve softly audible leak. Cuff inflation means no leak or minimal leak</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cuff Inflation and Cuff Deflation Groups</title>
          <description>Cuff deflation to achieve softly audible leak. Cuff inflation means no leak or minimal leak</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.3" lower_limit="1.8" upper_limit="5.3"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United Kingdom</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Temperature Difference (in Degrees Celsius) Between 2 Body Sites in Children Undergoing General Anaesthesia. The 2 Sites Are: (1) Lower Oesophagus; (2) Nasopharynx</title>
        <description>Temperature will be measured in the lower oesophagus of a child ventilated with a cuffed Endotracheal Tube (ETT). Readings will be recorded when there is no leak (cuff up) and when there is a clinically determinable, soft, audible leak (cuff down) around the ETT. Simultaneously temperature will also be measured in the nasopharynx.&#xD;
This will occur during general anaesthesia for a procedure that entails the performance of a radiograph (X-Ray) of the chest. The X-Ray will be used by the investigators to confirm correct placement of the temperature probe in the lower third of the oesophagus. We aim to show that the temperature measured in the lower oesophagus is the same or does not significantly differ from the temperature in the nasopharynx, even in the presence of a leak around the ETT. Temperature differences in degrees celsius will be reported.</description>
        <time_frame>6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Cuff Inflation and Cuff Deflation Groups</title>
            <description>Cuff deflation to achieve softly audible leak. Cuff inflation means no leak or minimal leak</description>
          </group>
        </group_list>
        <measure>
          <title>Temperature Difference (in Degrees Celsius) Between 2 Body Sites in Children Undergoing General Anaesthesia. The 2 Sites Are: (1) Lower Oesophagus; (2) Nasopharynx</title>
          <description>Temperature will be measured in the lower oesophagus of a child ventilated with a cuffed Endotracheal Tube (ETT). Readings will be recorded when there is no leak (cuff up) and when there is a clinically determinable, soft, audible leak (cuff down) around the ETT. Simultaneously temperature will also be measured in the nasopharynx.&#xD;
This will occur during general anaesthesia for a procedure that entails the performance of a radiograph (X-Ray) of the chest. The X-Ray will be used by the investigators to confirm correct placement of the temperature probe in the lower third of the oesophagus. We aim to show that the temperature measured in the lower oesophagus is the same or does not significantly differ from the temperature in the nasopharynx, even in the presence of a leak around the ETT. Temperature differences in degrees celsius will be reported.</description>
          <units>temperature difference degrees celsius</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.10" lower_limit="0.04" upper_limit="0.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Temperature Difference in the Presence of a Small Leak (Fractional Volume Loss &lt; 21%) and Large Leak (Fractional Volume Loss &gt; 21%)</title>
        <description>Sub-group analysis: Fractional Volume Loss (FVL) will be determined using spirometry readings taken during temperature measurements.</description>
        <time_frame>6 months</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Cuff Inflation and Cuff Deflation Groups</title>
          <description>Cuff deflation to achieve softly audible leak. Cuff inflation means no leak or minimal leak</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="59"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Nosebleed</sub_title>
                <description>On insertion of nasopharyngeal temperature probe. Minor and self-resolved</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Post-extubation stridor</sub_title>
                <description>Self-resolved without medical therapy. Associated with use of Microcuff endotracheal tube</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
              <event>
                <sub_title>Partially obstructed ETT during emergence</sub_title>
                <description>Associated with use of Microcuff endotracheal tube. Required suctioning with suction catheter, thereafter no further complications</description>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="59"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Dr Emily Haberman</name_or_title>
      <organization>King's College Hospital NHS Foundation Trust</organization>
      <phone>07890549924</phone>
      <email>emilysaffer@gmail.com</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/NCT02201628
org study id: 14SG04
nct id: NCT02201628
lead sponsor: 
has dmc: Yes
Children lose heat under general anaesthesia, thus temperature is routinely monitored during
      anaesthesia for all but the shortest cases, and active warming can be used to prevent
      hypothermia and its resulting complications. Temperature can be measured at several sites
      dependent on the type of surgery and patient factors. Previously a temperature probe has been
      sited in the lower third of the oesophagus (swallowing tube) but it is difficult to
      accurately place this without an X-Ray. Consequently it is more common to use a temperature
      probe placed in the nasopharynx (where the nose and throat meet), when the child is
      anaesthetised.

      However the investigators do not know if the temperature in the nasopharynx correlates well
      with the real core temperature or not.This prospective, unblinded, agreement study will seek
      to find an agreement of 2 methods to measure temperature in children undergoing general
      anaesthesia with a breathing tube that has a leak.
It is known that temperature in the lower third of the oesophagus correlates well with the
      gold standard of core temperature measurement, namely the temperature of blood in the heart.
      It is not known if oesophageal and nasopharyngeal temperatures correlate in children on a
      breathing machine via a tube with leak. If this study were to find a good correlation between
      oesophageal and nasopharyngeal temperature, this would allow clinicians to confidently use
      the more feasible nasopharyngeal temperature probes.

      For this study 100 children will have both nasopharyngeal and oesophageal temperatures
      measured during general anaesthesia, both in the presence and absence of a leak around the
      endotracheal tube.

      It is hypothesised that even in the presence of a leak, the temperature difference between
      the two methods will be less than 0.5 degrees centigrade.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Temperature Difference (in Degrees Celsius) Between 2 Body Sites in Children Undergoing General Anaesthesia. The 2 Sites Are: (1) Lower Oesophagus; (2) Nasopharynx
time frame: 6 months
description: Temperature will be measured in the lower oesophagus of a child ventilated with a cuffed Endotracheal Tube (ETT). Readings will be recorded when there is no leak (cuff up) and when there is a clinically determinable, soft, audible leak (cuff down) around the ETT. Simultaneously temperature will also be measured in the nasopharynx.
This will occur during general anaesthesia for a procedure that entails the performance of a radiograph (X-Ray) of the chest. The X-Ray will be used by the investigators to confirm correct placement of the temperature probe in the lower third of the oesophagus. We aim to show that the temperature measured in the lower oesophagus is the same or does not significantly differ from the temperature in the nasopharynx, even in the presence of a leak around the ETT. Temperature differences in degrees celsius will be reported.
measure: Temperature Difference in the Presence of a Small Leak (Fractional Volume Loss < 21%) and Large Leak (Fractional Volume Loss > 21%)
time frame: 6 months
description: Sub-group analysis: Fractional Volume Loss (FVL) will be determined using spirometry readings taken during temperature measurements.
arm group label: Nasopharyngeal and oesophageal temperatures
arm group type: Experimental
description: An oesophageal and nasopharyngeal temperature probe will be placed and temperature will be measured at these site
intervention type: Device
intervention name: Nasopharyngeal and oesophageal temperature probes
arm group label: Nasopharyngeal and oesophageal temperatures
other name: Covidien
other name: Mon-a-therm™ General Purpose Temperature Probe 400TM
other name: 90050
criteria: 
gender: All
minimum age: 8 Months
maximum age: 7 Years
healthy volunteers: No
last name: Aarjan P Snoek, MBChB, FRCA
role: Principal Investigator
affiliation: Great Ormond Street Hospital for Children NHS Foundation Trust
last name: Helen V Hume-Smith, MBBS, FRCA
role: Principal Investigator
affiliation: Great Ormond Street Hospital for Children NHS Foundation Trust
last name: Emily Haberman, MBBS, FRCA
role: Principal Investigator
affiliation: Great Ormond Street Hospital for Children NHS Foundation Trust
facility: 
country: United Kingdom
url: https://anestesiar.org/WP/uploads/2012/04/Microcuff-Paed-Endo-Tube.pdf
description: Kimberly-Clark. Important MicroCuff® Paediatric Endotracheal Tube Points to Remember
url: https://www.nice.org.uk/guidance/cg65/update/CG65/documents/perioperative-hypothermia-inadvertent-guideline-full-guideline-part-12
description: National Institute for Health and Clinical Excellence. The management of inadvertent perioperative hypothermia in adults: full guideline
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responsible party type: Sponsor
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 