<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/NCT03013036</url>
  </required_header>
  <id_info>
    <org_study_id>0964</org_study_id>
    <nct_id>NCT03013036</nct_id>
  </id_info>
  <brief_title>Ultrasonography for Prediction of Difficult Intubation and Prediction of Endotracheal Tube Size</brief_title>
  <official_title>Ultrasonographic Thyrohyoid Distance Measurement for Prediction of Difficult Intubation and Ultrasonographic Prediction of Pediatric Endotracheal Tube Size</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istanbul University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of our study is to evaluate the predictive value of ultrasonographic (USG) measurement of&#xD;
      thyrohyoid distance for difficult intubation and determination of optimal endotracheal tube&#xD;
      size by using USG in pediatric patients undergoing elective surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After ethics committee approval and parental consent were obtained, 119 patients undergoing&#xD;
      genitourinary surgery or inguinal hernia repair under general anesthesia, were included in&#xD;
      study. Patients with head or neck anomalies, syndromic patients, patients undergoing&#xD;
      emergency surgery and patients with a history of difficult airway were excluded from the&#xD;
      study. Patients were grouped according to their ages; Group I (1-2 years,n=38), Group II (3-5&#xD;
      years,n=46) and Group III (6-8 years,n=35). USG measurements were performed following&#xD;
      sevoflurane induction in groups I and II. In group III, USG measurements were performed&#xD;
      following premedication with intravenous midazolam 0.05 mg/kg . Thyrohyoid distance, glottic&#xD;
      and subglottic diameters were measured with ultrasonography. The size of the endotracheal&#xD;
      tube according to Bae's formula ( internal diameter of Endotracheal tube = 0.705 x subglottic&#xD;
      diameter - 0.091) was calculated and recorded. Before intubation, endotracheal tube&#xD;
      (cuffed/uncuffed) was selected using age-related formulas. In group II, anaesthesia induction&#xD;
      was achieved with propofol 2 mg/kg. In all groups, endotracheal intubation was achieved with&#xD;
      fentanyl 2μg/kg and rocuronium 0.6 mg/kg. Endotracheal tube size was considered as optimal&#xD;
      when a leak was detected at 20-30cmH₂O inflation pressures. If a resistance was felt in the&#xD;
      subglottic region, the tube was exchanged with a smaller and was exchanged with a larger (0.5&#xD;
      mm) size if a leak occurred at inflation pressures lower than 20cmH₂O. Intubation duration ,&#xD;
      Cormack-Lehane scores and Intubation Difficulty Scale scores were recorded. For comparison of&#xD;
      age related formula and Bae 's formula, only patients who were intubated with un-cuffed&#xD;
      endotracheal tube were evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2013</start_date>
  <primary_completion_date type="Anticipated">December 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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evidence of difficult intubation (determined with Intubation Difficulty Scale) in patients who have short thyrohyoid distance</measure>
    <time_frame>three years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Consistency of endotracheal tube sizes selected with aged related formulas and with ultrasonographic measurement of subglotic diameter</measure>
    <time_frame>three years</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Intubation; Difficult or Failed</condition>
  <arm_group>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients between 1 and 2 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients between 3 and 5 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group III</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>patients between 6 and 8 years</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasonography</intervention_name>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_label>Group III</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sevoflurane</intervention_name>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_label>Group III</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intravenous midazolam</intervention_name>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_label>Group III</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Propofol</intervention_name>
    <arm_group_label>Group II</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>fentanyl and rocuronium</intervention_name>
    <arm_group_label>Group I</arm_group_label>
    <arm_group_label>Group II</arm_group_label>
    <arm_group_label>Group III</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged between 1 and 8 years&#xD;
&#xD;
          -  Elective surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with head or neck abnormalities&#xD;
&#xD;
          -  Syndromic patients&#xD;
&#xD;
          -  Emergency surgery and patients with a&#xD;
&#xD;
          -  History of difficult airway&#xD;
&#xD;
          -  Allergy to ultrasound gel&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Elif A Ozmumcu, M.D.</last_name>
    <phone>00905332934202</phone>
    <email>elfaybike@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Fatis Altindas, M.D.</last_name>
    <phone>00905337785278</phone>
    <email>fatisaltitas@hotmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Istanbul University Cerrahpasa Medical Faculty</name>
      <address>
        <city>Istanbul</city>
        <state>Fatih</state>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fatis Altindas, M.D.</last_name>
      <phone>00905337785278</phone>
      <email>fatisaltindas@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Elif Aybike Ozmumcu</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Midazolam</mesh_term>
    <mesh_term>Propofol</mesh_term>
    <mesh_term>Sevoflurane</mesh_term>
    <mesh_term>Rocuronium</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>September 8, 2021</submitted>
    <returned>October 5, 2021</returned>
  </pending_results>
  <!-- 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/NCT03013036
org study id: 0964
nct id: NCT03013036
lead sponsor: 
has dmc: Yes
Aim of our study is to evaluate the predictive value of ultrasonographic (USG) measurement of
      thyrohyoid distance for difficult intubation and determination of optimal endotracheal tube
      size by using USG in pediatric patients undergoing elective surgery.
After ethics committee approval and parental consent were obtained, 119 patients undergoing
      genitourinary surgery or inguinal hernia repair under general anesthesia, were included in
      study. Patients with head or neck anomalies, syndromic patients, patients undergoing
      emergency surgery and patients with a history of difficult airway were excluded from the
      study. Patients were grouped according to their ages; Group I (1-2 years,n=38), Group II (3-5
      years,n=46) and Group III (6-8 years,n=35). USG measurements were performed following
      sevoflurane induction in groups I and II. In group III, USG measurements were performed
      following premedication with intravenous midazolam 0.05 mg/kg . Thyrohyoid distance, glottic
      and subglottic diameters were measured with ultrasonography. The size of the endotracheal
      tube according to Bae's formula ( internal diameter of Endotracheal tube = 0.705 x subglottic
      diameter - 0.091) was calculated and recorded. Before intubation, endotracheal tube
      (cuffed/uncuffed) was selected using age-related formulas. In group II, anaesthesia induction
      was achieved with propofol 2 mg/kg. In all groups, endotracheal intubation was achieved with
      fentanyl 2μg/kg and rocuronium 0.6 mg/kg. Endotracheal tube size was considered as optimal
      when a leak was detected at 20-30cmH₂O inflation pressures. If a resistance was felt in the
      subglottic region, the tube was exchanged with a smaller and was exchanged with a larger (0.5
      mm) size if a leak occurred at inflation pressures lower than 20cmH₂O. Intubation duration ,
      Cormack-Lehane scores and Intubation Difficulty Scale scores were recorded. For comparison of
      age related formula and Bae 's formula, only patients who were intubated with un-cuffed
      endotracheal tube were evaluated.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Evidence of difficult intubation (determined with Intubation Difficulty Scale) in patients who have short thyrohyoid distance
time frame: three years
measure: Consistency of endotracheal tube sizes selected with aged related formulas and with ultrasonographic measurement of subglotic diameter
time frame: three years
arm group label: Group I
arm group type: Other
description: Patients between 1 and 2 years
arm group label: Group II
arm group type: Other
description: patients between 3 and 5 years
arm group label: Group III
arm group type: Other
description: patients between 6 and 8 years
intervention type: Device
intervention name: Ultrasonography
arm group label: Group I
arm group label: Group II
arm group label: Group III
intervention type: Drug
intervention name: Sevoflurane
arm group label: Group I
arm group label: Group II
arm group label: Group III
intervention type: Drug
intervention name: intravenous midazolam
arm group label: Group I
arm group label: Group III
intervention type: Drug
intervention name: Propofol
arm group label: Group II
intervention type: Drug
intervention name: fentanyl and rocuronium
arm group label: Group I
arm group label: Group II
arm group label: Group III
criteria: 
gender: All
minimum age: 1 Year
maximum age: 8 Years
healthy volunteers: No
last name: Elif A Ozmumcu, M.D.
phone: 00905332934202
email: elfaybike@yahoo.com
last name: Fatis Altindas, M.D.
phone: 00905337785278
email: fatisaltitas@hotmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Elif Aybike Ozmumcu
investigator title: Medical Doctor
mesh term: Fentanyl
mesh term: Midazolam
mesh term: Propofol
mesh term: Sevoflurane
mesh term: Rocuronium
sharing ipd: Undecided
submitted: September 8, 2021
returned: October 5, 2021