xml: <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/NCT05974540</url>
    </required_header>
    <id_info>
      <org_study_id>09.2023.605</org_study_id>
      <nct_id>NCT05974540</nct_id>
    </id_info>
    <brief_title>USG vs Palpation for Cricothyroid Membrane Determination</brief_title>
    <official_title>Ultrasound Versus Physical Examination for Cricothyroid Membrane Determination in Pediatric Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Marmara University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Marmara University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Emergency cricothyroidotomy is a very important technique to ensure airway safety in acute&#xD;
        situations. Problem in identifying the cricothyroid membrane is a major contributor to high&#xD;
        failure, as the most common complication during cricothyrotomy is the misplacement of the&#xD;
        cannula. The success rate of emergency airway access performed by anesthesiologists and&#xD;
        emergency medicine specialists was found to be low due to the low frequency of the procedure.&#xD;
        The aim in this study is to compare the palpation method with the ultrasonugraphy (USG)-based&#xD;
        method in determining the cricothyroid membrane. The hypothesis is that USG is more&#xD;
        successful than palpation in identifying the cricothyroid membrane. In addition, the&#xD;
        relationship between difficult intubation and measurements such as the cricothyroid membrane&#xD;
        length, the cricoid cartilage and the skin distance, the distance between the cricoid&#xD;
        cartilage and the second tracheal ring will be evaluated.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">July 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2024</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>Distance between palpation-based and USG-based determination of the cricothyroid membrane</measure>
      <time_frame>On the 1 day of the surgery. After the anesthesia induction and intubation.</time_frame>
      <description>Regarding the determination point of the cricothyroid membrane the distance between palpation-based method performed by pediatric surgeon and USG-based method performed by anesthesiologist will be measured.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cricothyroid membrane length</measure>
      <time_frame>On the 1 day of the surgery. After the anesthesia induction and intubation.</time_frame>
      <description>Cricothyroid membrane length will be measured by anesthesiologist using USG. Longitudinal view of the thyroid, cricoid and trakeal ring cartilages will be obtained and the measurement will be made.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Skin distance from cricoid cartilage</measure>
      <time_frame>On the 1 day of the surgery. After the anesthesia induction and intubation.</time_frame>
      <description>Skin distance from cricoid cartilage will be measured by anesthesiologist using USG. Longitudinal view of the thyroid, cricoid and trakeal ring cartilages will be obtained and the measurement will be made.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distance between cricoid cartilage and 2nd tracheal ring</measure>
      <time_frame>On the 1 day of the surgery. After the anesthesia induction and intubation.</time_frame>
      <description>Distance between cricoid cartilage and 2nd tracheal ring will be measured by anesthesiologist using USG. Longitudinal view of the thyroid, cricoid and trakeal ring cartilages will be obtained and the measurement will be made.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Ultrasound</condition>
    <condition>Cricothyroid Membrane</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Determination of cricothyroid membrane</intervention_name>
      <description>After the patient's head is extended, the pediatric surgeon will be asked to mark the cricothyroid membrane with a pencil using traditional inspection and palpation methods. Then, the cricothyroid membrane will be determined by the Anesthesiology and Reanimation specialist by USG method and the difference will be determined. Demographic and morphometric characteristics of the patients will be recorded. In addition, the length of the cricothyroid membrane, the distance between the cricoid cartilage and the skin, the distance between the cricoid cartilage and the 2nd tracheal ring will be measured by USG.&#xD;
  Mallampati classes of patients with intubation, Cormack-Lehane (CL) glottic appearance grades, Likert scale with intubation difficulties (1: very easy, 2: easy, 3: medium, 4: difficult) will also be recorded.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Pediatric patients between the ages of 1-18, who are in ASA I-II physical status and who&#xD;
          will undergo elective surgery under general anesthesia by the Pediatric Surgery at Marmara&#xD;
          University Pendik Training and Research Hospital will be included in the study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  American Society of Anaesthesiologists (ASA) I and II physical status&#xD;
  &#xD;
            -  Elective pediatric surgery&#xD;
  &#xD;
            -  Patients going to be intubated&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  ASA III or above physical status&#xD;
  &#xD;
            -  Emergency surgery&#xD;
  &#xD;
            -  Patients having tracheostomy&#xD;
  &#xD;
            -  Patients going to have laryngeal mask&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Ruslan Abdullayev</last_name>
      <role>Principal Investigator</role>
      <affiliation>Marmara University Department of Anesthesiology and Reanimation</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ruslan Abdullayev</last_name>
      <phone>+905063010833</phone>
      <email>ruslan_jnr@hotmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Marmara University Department of Anesthesiology and Reanimation</name>
        <address>
          <city>Istanbul</city>
          <zip>34912</zip>
          <country>Turkey</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Ruslan Abdullayev</last_name>
        <phone>+905063010833</phone>
        <email>ruslan_jnr@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Marmara University</investigator_affiliation>
      <investigator_full_name>Ruslan Abdullayev</investigator_full_name>
      <investigator_title>Assoc. Prof.</investigator_title>
    </responsible_party>
    <keyword>Cricothyrotomy</keyword>
    <keyword>Palpation</keyword>
    <keyword>Ultrasonography</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05974540
  org study id: 09.2023.605
  nct id: NCT05974540
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Emergency cricothyroidotomy is a very important technique to ensure airway safety in acute
        situations. Problem in identifying the cricothyroid membrane is a major contributor to high
        failure, as the most common complication during cricothyrotomy is the misplacement of the
        cannula. The success rate of emergency airway access performed by anesthesiologists and
        emergency medicine specialists was found to be low due to the low frequency of the procedure.
        The aim in this study is to compare the palpation method with the ultrasonugraphy (USG)-based
        method in determining the cricothyroid membrane. The hypothesis is that USG is more
        successful than palpation in identifying the cricothyroid membrane. In addition, the
        relationship between difficult intubation and measurements such as the cricothyroid membrane
        length, the cricoid cartilage and the skin distance, the distance between the cricoid
        cartilage and the second tracheal ring will be evaluated.
  observational model: Cohort
  time perspective: Prospective
  measure: Distance between palpation-based and USG-based determination of the cricothyroid membrane
  time frame: On the 1 day of the surgery. After the anesthesia induction and intubation.
  description: Regarding the determination point of the cricothyroid membrane the distance between palpation-based method performed by pediatric surgeon and USG-based method performed by anesthesiologist will be measured.
  measure: Cricothyroid membrane length
  time frame: On the 1 day of the surgery. After the anesthesia induction and intubation.
  description: Cricothyroid membrane length will be measured by anesthesiologist using USG. Longitudinal view of the thyroid, cricoid and trakeal ring cartilages will be obtained and the measurement will be made.
  measure: Skin distance from cricoid cartilage
  time frame: On the 1 day of the surgery. After the anesthesia induction and intubation.
  description: Skin distance from cricoid cartilage will be measured by anesthesiologist using USG. Longitudinal view of the thyroid, cricoid and trakeal ring cartilages will be obtained and the measurement will be made.
  measure: Distance between cricoid cartilage and 2nd tracheal ring
  time frame: On the 1 day of the surgery. After the anesthesia induction and intubation.
  description: Distance between cricoid cartilage and 2nd tracheal ring will be measured by anesthesiologist using USG. Longitudinal view of the thyroid, cricoid and trakeal ring cartilages will be obtained and the measurement will be made.
  intervention type: Diagnostic Test
  intervention name: Determination of cricothyroid membrane
  description: After the patient's head is extended, the pediatric surgeon will be asked to mark the cricothyroid membrane with a pencil using traditional inspection and palpation methods. Then, the cricothyroid membrane will be determined by the Anesthesiology and Reanimation specialist by USG method and the difference will be determined. Demographic and morphometric characteristics of the patients will be recorded. In addition, the length of the cricothyroid membrane, the distance between the cricoid cartilage and the skin, the distance between the cricoid cartilage and the 2nd tracheal ring will be measured by USG.
  Mallampati classes of patients with intubation, Cormack-Lehane (CL) glottic appearance grades, Likert scale with intubation difficulties (1: very easy, 2: easy, 3: medium, 4: difficult) will also be recorded.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: 18 Years
  healthy volunteers: No
  last name: Ruslan Abdullayev
  role: Principal Investigator
  affiliation: Marmara University Department of Anesthesiology and Reanimation
  last name: Ruslan Abdullayev
  phone: +905063010833
  email: ruslan_jnr@hotmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Marmara University
  investigator full name: Ruslan Abdullayev
  investigator title: Assoc. Prof.
  sharing ipd: Undecided