<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/NCT02975791</url>
  </required_header>
  <id_info>
    <org_study_id>Ultrasound MC 24112016</org_study_id>
    <nct_id>NCT02975791</nct_id>
  </id_info>
  <brief_title>Ultrasonography Versus Palpation for Identification of the Cricothyroid Membrane</brief_title>
  <official_title>Ultrasonography Versus Palpation for Identification of the Cricothyroid Membrane</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      After a structured teaching program anaesthetists are educated in identifying the&#xD;
      cricothyroid membrane with ultrasonography. Thereafter their ability to do so is compared&#xD;
      with their ability to do so with palpation. In an obese volunteer&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After a structured teaching program anaesthetists are educated in identifying the&#xD;
      cricothyroid membrane with ultrasonography. Thereafter their ability to do so is compared&#xD;
      with their ability to do so with palpation.&#xD;
&#xD;
      The purpose is to advise a propriety method for preanesthetic identification. In an obese&#xD;
      volunteer&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">February 2017</completion_date>
  <primary_completion_date type="Anticipated">February 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of correct identification of the cricothyroid membrane</measure>
    <time_frame>&quot;2 min&quot;</time_frame>
    <description>The fraction of cases where the cricothyroid membrane is identified correctly</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>time to correct identification of the cricothyroid membrane</measure>
    <time_frame>&quot;2 min&quot;</time_frame>
    <description>The time consumed for correct identification of the cricothyroid membrane</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Airway Obstruction</condition>
  <arm_group>
    <arm_group_label>palpation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Marking the cricothyroid membrane after ultrasound&#xD;
The intervention is to mark the cricothyroid membrane in order to know exactly where it is in case that it should be needed fur emergency cricothyrotomy. The doctors mark the cricothyroid membrane with a pen after using palpation for identification.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ultrasound</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Marking of the cricothyroid membrane after Palpation&#xD;
intervention is to mark the cricothyroid membrane in order to know exactly where it is in case that it should be needed fur emergency cricothyrotomy doctors mark the cricothyroid membrane with a pen after using ultrasonography for the identification</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Marking the cricothyroid membrane after ultrasound</intervention_name>
    <description>Ultrasonography is applied to the subjects neck in order to identify the cricothyroid membrane - subsequently the membrane is marked with a pen</description>
    <arm_group_label>ultrasound</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Marking of the cricothyroid membrane after Palpation</intervention_name>
    <description>Palpation is applied to the subjects neck in order to identify the cricothyroid membrane- subsequently the membrane is marked with a pen</description>
    <arm_group_label>palpation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &gt; 40&#xD;
&#xD;
          -  Female&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age below 18&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 20, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 28, 2016</last_update_submitted>
  <last_update_submitted_qc>November 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 29, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Michael Seltz Kristensen</investigator_full_name>
    <investigator_title>Consultant</investigator_title>
  </responsible_party>
  <keyword>Airway Obstruction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Airway Obstruction</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/NCT02975791
org study id: Ultrasound MC 24112016
nct id: NCT02975791
lead sponsor: 
has dmc: No
After a structured teaching program anaesthetists are educated in identifying the
      cricothyroid membrane with ultrasonography. Thereafter their ability to do so is compared
      with their ability to do so with palpation. In an obese volunteer
After a structured teaching program anaesthetists are educated in identifying the
      cricothyroid membrane with ultrasonography. Thereafter their ability to do so is compared
      with their ability to do so with palpation.

      The purpose is to advise a propriety method for preanesthetic identification. In an obese
      volunteer
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Frequency of correct identification of the cricothyroid membrane
time frame: "2 min"
description: The fraction of cases where the cricothyroid membrane is identified correctly
measure: time to correct identification of the cricothyroid membrane
time frame: "2 min"
description: The time consumed for correct identification of the cricothyroid membrane
arm group label: palpation
arm group type: Active Comparator
description: Marking the cricothyroid membrane after ultrasound
The intervention is to mark the cricothyroid membrane in order to know exactly where it is in case that it should be needed fur emergency cricothyrotomy. The doctors mark the cricothyroid membrane with a pen after using palpation for identification.
arm group label: ultrasound
arm group type: Active Comparator
description: Marking of the cricothyroid membrane after Palpation
intervention is to mark the cricothyroid membrane in order to know exactly where it is in case that it should be needed fur emergency cricothyrotomy doctors mark the cricothyroid membrane with a pen after using ultrasonography for the identification
intervention type: Other
intervention name: Marking the cricothyroid membrane after ultrasound
description: Ultrasonography is applied to the subjects neck in order to identify the cricothyroid membrane - subsequently the membrane is marked with a pen
arm group label: ultrasound
intervention type: Procedure
intervention name: Marking of the cricothyroid membrane after Palpation
description: Palpation is applied to the subjects neck in order to identify the cricothyroid membrane- subsequently the membrane is marked with a pen
arm group label: palpation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Michael Seltz Kristensen
investigator title: Consultant
mesh term: Airway Obstruction
sharing ipd: No