<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/NCT03799055</url>
  </required_header>
  <id_info>
    <org_study_id>Us in difficult airway</org_study_id>
    <nct_id>NCT03799055</nct_id>
  </id_info>
  <brief_title>Ultrasonography vs Conventional Methods for Prediction of Difficult Airway in Adult Patients</brief_title>
  <official_title>Ultrasonography(Distance From Skin to Epiglottis) vs Conventional Methods (Mallampati Score &amp; Thyromental Distance) for Prediction of Difficult Airway in Adult Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Benha University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Benha University</source>
  <brief_summary>
    <textblock>
      The aim of this study to assess and compare between methods of prediction of difficult airway&#xD;
      including Mallmpati score , thyromental distance and us measured distance from skin to&#xD;
      epiglottis(DES) t the level of thyrohyoid membrane in adult patients requiring endotracheal&#xD;
      intubation for an elective surgical procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 10, 2019</start_date>
  <completion_date type="Actual">January 10, 2020</completion_date>
  <primary_completion_date type="Actual">December 29, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prediction of difficult airway</measure>
    <time_frame>Preoperative</time_frame>
    <description>Assess which method is better for prediction of difficult airway DES or conventional</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Difficult Intubation</condition>
  <arm_group>
    <arm_group_label>easy intubation</arm_group_label>
    <description>Cormack _Lehane : 1&amp;2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>difficult intubation</arm_group_label>
    <description>Cormack _Lehane : 3&amp;4</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients at Benha University Surgical Hospital scheduled for elective surgical procedures&#xD;
        requiring endotracheal tube&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anaesthesia class 1,2and 3.&#xD;
&#xD;
          -  elective surgical procedure requiring endotracheal intubation.&#xD;
&#xD;
          -  Age 18_60 years old.&#xD;
&#xD;
          -  BMI less than 40kg/meter square.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients refusal.&#xD;
&#xD;
          -  Unable to give consent.&#xD;
&#xD;
          -  Preexisting airway malformations or pathology.&#xD;
&#xD;
          -  History of difficult intubation.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Patients with tracheostomy tube.&#xD;
&#xD;
          -  BMI more than 40 kg/meter square.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Faculty Of Medicine</last_name>
    <role>Study Director</role>
    <affiliation>faculty of medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Benha University Hospital</name>
      <address>
        <city>Banhā</city>
        <state>Banha</state>
        <zip>13518</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>April 20, 2020</last_update_submitted>
  <last_update_submitted_qc>April 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Benha University</investigator_affiliation>
    <investigator_full_name>Baher Said Elshahat Mohamed Abdelhady</investigator_full_name>
    <investigator_title>Principal investigator</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/NCT03799055
org study id: Us in difficult airway
nct id: NCT03799055
lead sponsor: 
The aim of this study to assess and compare between methods of prediction of difficult airway
      including Mallmpati score , thyromental distance and us measured distance from skin to
      epiglottis(DES) t the level of thyrohyoid membrane in adult patients requiring endotracheal
      intubation for an elective surgical procedure.
observational model: Other
time perspective: Prospective
measure: Prediction of difficult airway
time frame: Preoperative
description: Assess which method is better for prediction of difficult airway DES or conventional
arm group label: easy intubation
description: Cormack _Lehane : 1&2
arm group label: difficult intubation
description: Cormack _Lehane : 3&4
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Faculty Of Medicine
role: Study Director
affiliation: faculty of medicine
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Benha University
investigator full name: Baher Said Elshahat Mohamed Abdelhady
investigator title: Principal investigator
sharing ipd: No