<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/NCT03280498</url>
  </required_header>
  <id_info>
    <org_study_id>83045809</org_study_id>
    <nct_id>NCT03280498</nct_id>
  </id_info>
  <brief_title>Effectiveness of Ultrasonography and The Cole Formula on the Evaluation of the Appropriate Endotracheal Tube Size</brief_title>
  <official_title>Effectiveness of Ultrasonography and The Cole Formula on the Evaluation of the Appropriate 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>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>
      In this study the effectiveness of the use of Cole formula and USG were compared in&#xD;
      determining the number of the appropriate uncuffed ETT to be used for clinically adequate&#xD;
      ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Aim: The goal of this study was to evaluate the effectiveness of the Cole formula and&#xD;
      ultrasonography in determining endotracheal tube size for paediatric surgery patients.&#xD;
&#xD;
      Material and methods: ASA I-II pediatric patients (n=110) in the age range of 2-10 years,&#xD;
      planned to undergo elective surgeries under general anesthesia with endotracheal entubation,&#xD;
      were enrolled in this study. Once patients were properly positioned after premedication and&#xD;
      anesthesia induction, the subglottic diameter was measured using ultrasonography, and&#xD;
      endotracheal tube (ETT) size was also calculated with the Cole formula. Subsequently patients&#xD;
      were entubated with uncuffed ETT with sizes based on the patient's age in compliance with&#xD;
      current clinical guide lines. To ensure adequate ventilation, the tube was replaced with an&#xD;
      ETT of larger or smaller diameter as needed. The ETT was fastened after the placement ring&#xD;
      had passed through the vocal cords and breath sounds were confirmed to be equal by&#xD;
      auscultation. The size of the used ETT was compared with the size estimated from the&#xD;
      subglottic diameter measured by ultrasonography to the size calculated with the Cole formula&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 3, 2017</start_date>
  <completion_date type="Actual">October 31, 2017</completion_date>
  <primary_completion_date type="Actual">October 25, 2017</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>: The goal of this study was to evaluate the effectiveness of the Cole formula and ultrasonography in determining endotracheal tube size for paediatric surgery patients.</measure>
    <time_frame>12 months</time_frame>
    <description>efficiency of formula</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine the correlation of weight, height and age of child with USG based endotracheal tube size, Cole formula endotracheal tube size and clinically used endotracheal tube size</measure>
    <time_frame>12 months</time_frame>
    <description>efficiency of USG</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">110</enrollment>
  <condition>Intubation</condition>
  <arm_group>
    <arm_group_label>Intubation with Cole formula</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>ASA I-II pediatric patients in the age range of 2-10 years, planned to undergo elective surgeries under general anesthesia with endotracheal entubation,</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intubation</intervention_name>
    <description>elective surgeries under general anesthesia with endotracheal entubation formula or USG asisted</description>
    <arm_group_label>Intubation with Cole formula</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:Children between 2 and 10 years of age, in the ASA I-II classification&#xD;
        for whom elective surgery&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Children having a diagnosed syndrome, any anomaly of the upper respiratory tract and the&#xD;
        head-neck region, recent or active upper respiratory tract infection, previous&#xD;
        tracheastomy, requiring nasotracheal entubation, requiring surgery on an emergency basis&#xD;
        and being in the ASA III-IV classification -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cerrahpasa Medical Faculty</name>
      <address>
        <city>Istanbul</city>
        <state>Cerrahpasa</state>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>November 17, 2017</last_update_submitted>
  <last_update_submitted_qc>November 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Ayse Cigdem Tutuncu</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <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/NCT03280498
org study id: 83045809
nct id: NCT03280498
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study the effectiveness of the use of Cole formula and USG were compared in
      determining the number of the appropriate uncuffed ETT to be used for clinically adequate
      ventilation.
Aim: The goal of this study was to evaluate the effectiveness of the Cole formula and
      ultrasonography in determining endotracheal tube size for paediatric surgery patients.

      Material and methods: ASA I-II pediatric patients (n=110) in the age range of 2-10 years,
      planned to undergo elective surgeries under general anesthesia with endotracheal entubation,
      were enrolled in this study. Once patients were properly positioned after premedication and
      anesthesia induction, the subglottic diameter was measured using ultrasonography, and
      endotracheal tube (ETT) size was also calculated with the Cole formula. Subsequently patients
      were entubated with uncuffed ETT with sizes based on the patient's age in compliance with
      current clinical guide lines. To ensure adequate ventilation, the tube was replaced with an
      ETT of larger or smaller diameter as needed. The ETT was fastened after the placement ring
      had passed through the vocal cords and breath sounds were confirmed to be equal by
      auscultation. The size of the used ETT was compared with the size estimated from the
      subglottic diameter measured by ultrasonography to the size calculated with the Cole formula
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: : The goal of this study was to evaluate the effectiveness of the Cole formula and ultrasonography in determining endotracheal tube size for paediatric surgery patients.
time frame: 12 months
description: efficiency of formula
measure: To determine the correlation of weight, height and age of child with USG based endotracheal tube size, Cole formula endotracheal tube size and clinically used endotracheal tube size
time frame: 12 months
description: efficiency of USG
arm group label: Intubation with Cole formula
arm group type: Other
description: ASA I-II pediatric patients in the age range of 2-10 years, planned to undergo elective surgeries under general anesthesia with endotracheal entubation,
intervention type: Procedure
intervention name: Intubation
description: elective surgeries under general anesthesia with endotracheal entubation formula or USG asisted
arm group label: Intubation with Cole formula
criteria: 
gender: All
minimum age: 2 Years
maximum age: 10 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Ayse Cigdem Tutuncu
investigator title: MD
sharing ipd: No