<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/NCT02988336</url>
  </required_header>
  <id_info>
    <org_study_id>TMHT-01</org_study_id>
    <nct_id>NCT02988336</nct_id>
  </id_info>
  <brief_title>TMHT - New Method of Difficult Intubation Prediction</brief_title>
  <official_title>Thyromental Height Test as a New Method for Prediction of Difficult Intubation With Double Lumen Tube</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Silesia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Silesia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the usefulness of the Thyromental Height Test in&#xD;
      prediction of difficult intubation using double lumen endotracheal tubes in patients&#xD;
      scheduled for elective thoracic procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Proper prediction of the occurrence of difficult intubation plays a crucial role in&#xD;
      anaesthesiology. For years attempts have been made to develop methods allowing&#xD;
      anaesthesiologists to correctly predict the occurrence of difficult intubation. None of the&#xD;
      currently used tests and anthropometric measurements present satisfying predictive value.&#xD;
      Recent studies show promise in Thyromental Height Test (TMHT), which base on the height&#xD;
      between the anterior borders of the mentum and the thyroid cartilage, measured while the&#xD;
      patient lies in the supine position with closed mouth, as a single, non-invasive predictor of&#xD;
      difficult intubation. Use of double lumen endotracheal tubes during thoracic procedures, due&#xD;
      to greater diameter of the tube, may lead to higher occurrence of difficult intubation. That&#xD;
      is why, the purpose of this study is to assess the usefulness of the TMHT in prediction of&#xD;
      difficult intubation using double lumen endotracheal tubes in patients scheduled for elective&#xD;
      thoracic procedures and relate it to other, commonly used predictive tests.&#xD;
&#xD;
      During routine, preoperative anaesthetic visit thyromental height, thyromental distance,&#xD;
      sternomental distance and Mallampati scale score are assessed. Then, during direct&#xD;
      laryngoscopy and intubation, score in Cormack-Lehane scale and occurrence of difficult&#xD;
      intubation are noted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</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>Thyromental height</measure>
    <time_frame>immediate</time_frame>
    <description>The height between the anterior border of the thyroid cartilage (on the thyroid notch just between the 2 thyroid laminae) and the anterior border of the mentum (on the mental protuberance of the mandible), in supine position with mouth closed, measured with a depth gauge, measured during routine preoperative anaesthetic visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Thyromental distance</measure>
    <time_frame>immediate</time_frame>
    <description>The distance between the thyroid prominence and the most anterior part of the mental prominence of the mandible, measured with a standard centigrade ruler as the distance in centimetres with the patient in supine position, head fully extended, mouth closed, during routine preoperative anaesthetic visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sternomental distance</measure>
    <time_frame>immediate</time_frame>
    <description>The distance in centimetres between the superior border of the manubrium sterni and the bony point of the mentum, with the patient in supine position, head fully extended, mouth closed, measured with a standard centigrade ruler, during routine preoperative anaesthetic visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>score in modified Mallampati test</measure>
    <time_frame>immediate</time_frame>
    <description>The oropharyngeal view is assessed in sitting position, mouth maximally opened, tongue protruded, without phonation, measured during routine preoperative anaesthetic visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>score in Cormack-Lehane scale</measure>
    <time_frame>immediate</time_frame>
    <description>During direct laryngoscopy the patient is graded in Cormack-Lehane Scale by the laryngoscopist.</description>
  </secondary_outcome>
  <enrollment type="Actual">237</enrollment>
  <condition>Airway Management</condition>
  <condition>Predictive Value of Tests</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients undergoing elective thoracic procedures in university hospital,&#xD;
        requiring general anaesthesia, elective direct laryngoscopy and intubation with a double&#xD;
        lumen endotracheal tubes.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients scheduled for elective thoracic procedures, requiring general anaesthesia,&#xD;
             direct laryngoscopy and intubation with a Robertshaw type double lumen endotracheal&#xD;
             tubes&#xD;
&#xD;
          -  consent for participation in the trail&#xD;
&#xD;
          -  older than 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency procedures&#xD;
&#xD;
          -  visible anatomic abnormalities&#xD;
&#xD;
          -  patients scheduled for awake fibre optic intubation&#xD;
&#xD;
          -  lack of consent for participation in the trail&#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>Hanna Misiołek, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>School of Medicine with the Division of Dentistry in Zabrze. Medical University of Silesia. Department of Anaesthesiology and Critical Care.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Samodzielny Publiczny Szpital Kliniczny nr 1</name>
      <address>
        <city>Zabrze</city>
        <state>Silesia</state>
        <zip>41-800</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>January 29, 2017</last_update_submitted>
  <last_update_submitted_qc>January 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Silesia</investigator_affiliation>
    <investigator_full_name>Piotr Palaczyński</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>difficult intubation</keyword>
  <keyword>thyromental height</keyword>
  <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/NCT02988336
org study id: TMHT-01
nct id: NCT02988336
lead sponsor: 
has dmc: No
The purpose of this study is to assess the usefulness of the Thyromental Height Test in
      prediction of difficult intubation using double lumen endotracheal tubes in patients
      scheduled for elective thoracic procedures.
Proper prediction of the occurrence of difficult intubation plays a crucial role in
      anaesthesiology. For years attempts have been made to develop methods allowing
      anaesthesiologists to correctly predict the occurrence of difficult intubation. None of the
      currently used tests and anthropometric measurements present satisfying predictive value.
      Recent studies show promise in Thyromental Height Test (TMHT), which base on the height
      between the anterior borders of the mentum and the thyroid cartilage, measured while the
      patient lies in the supine position with closed mouth, as a single, non-invasive predictor of
      difficult intubation. Use of double lumen endotracheal tubes during thoracic procedures, due
      to greater diameter of the tube, may lead to higher occurrence of difficult intubation. That
      is why, the purpose of this study is to assess the usefulness of the TMHT in prediction of
      difficult intubation using double lumen endotracheal tubes in patients scheduled for elective
      thoracic procedures and relate it to other, commonly used predictive tests.

      During routine, preoperative anaesthetic visit thyromental height, thyromental distance,
      sternomental distance and Mallampati scale score are assessed. Then, during direct
      laryngoscopy and intubation, score in Cormack-Lehane scale and occurrence of difficult
      intubation are noted.
observational model: Cohort
time perspective: Prospective
measure: Thyromental height
time frame: immediate
description: The height between the anterior border of the thyroid cartilage (on the thyroid notch just between the 2 thyroid laminae) and the anterior border of the mentum (on the mental protuberance of the mandible), in supine position with mouth closed, measured with a depth gauge, measured during routine preoperative anaesthetic visit.
measure: Thyromental distance
time frame: immediate
description: The distance between the thyroid prominence and the most anterior part of the mental prominence of the mandible, measured with a standard centigrade ruler as the distance in centimetres with the patient in supine position, head fully extended, mouth closed, during routine preoperative anaesthetic visit.
measure: Sternomental distance
time frame: immediate
description: The distance in centimetres between the superior border of the manubrium sterni and the bony point of the mentum, with the patient in supine position, head fully extended, mouth closed, measured with a standard centigrade ruler, during routine preoperative anaesthetic visit.
measure: score in modified Mallampati test
time frame: immediate
description: The oropharyngeal view is assessed in sitting position, mouth maximally opened, tongue protruded, without phonation, measured during routine preoperative anaesthetic visit.
measure: score in Cormack-Lehane scale
time frame: immediate
description: During direct laryngoscopy the patient is graded in Cormack-Lehane Scale by the laryngoscopist.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hanna Misiołek, MD PhD
role: Study Chair
affiliation: School of Medicine with the Division of Dentistry in Zabrze. Medical University of Silesia. Department of Anaesthesiology and Critical Care.
facility: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Silesia
investigator full name: Piotr Palaczyński
investigator title: Principal Investigator
sharing ipd: No