<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/NCT02969889</url>
  </required_header>
  <id_info>
    <org_study_id>KOU KAEK 2014/137</org_study_id>
    <nct_id>NCT02969889</nct_id>
  </id_info>
  <brief_title>Intubation in Morbidly Obese: a Comparison of Airtraq and ILMA</brief_title>
  <official_title>Intubation in Morbidly Obese: a Comparison of Airtraq and ILMA</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kocaeli University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kocaeli University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      bmı &gt; 35 morbidly obese patients requiring endotracheal intubation enrolled in this trial.&#xD;
      Divided into two groups Airtraq and ILMA. their effectiveness is evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      80 patients, 18-65 years of aged ASA I-III, BMI&gt; 35 patients enrolled in this trial.&#xD;
&#xD;
      Divided into two groups ; Airtraq and ILMA .&#xD;
&#xD;
      BMI&gt;35, upper airway tumour , respiratory infection less than ten days, excluded from this&#xD;
      study.&#xD;
&#xD;
      patients demographic and airway variables were recoded. Patients were premedicated. After&#xD;
      standard anesthesia induction, anesthesia was induced with propofol and fentanyl. Rocuronium&#xD;
      was used for neuromuscular blockade.&#xD;
&#xD;
      The device insertion and intubation times, number of intubation attempts, mucosal damage,&#xD;
      need for optimization maneuvers, effects on hemodynamic parameters and postoperative minor&#xD;
      complications were recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Actual">November 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</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>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intubation time</measure>
    <time_frame>1 minute</time_frame>
    <description>handling of the device till the endotracheal tube entering the glottis</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Intubation; Difficult or Failed</condition>
  <condition>Intubation Complication</condition>
  <arm_group>
    <arm_group_label>intubation time</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>handling the device till the endotracheal tube passing through the glottis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>insertion time</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>handling of the device till the glottic visualization</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Airtraq</intervention_name>
    <description>video laryngoscope with a channel</description>
    <arm_group_label>insertion time</arm_group_label>
    <arm_group_label>intubation time</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ILMA</intervention_name>
    <arm_group_label>insertion time</arm_group_label>
    <arm_group_label>intubation time</arm_group_label>
    <other_name>intubating laryngeal mask airway</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:18-65 years of age&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
          -  BMI&gt;35&#xD;
&#xD;
        Exclusion Criteria:BMI&lt;35&#xD;
&#xD;
          -  patients have airway tumor&#xD;
&#xD;
          -  patients undergoing head and neck surgery&#xD;
&#xD;
          -  upper respiratory infection less than 10 days prior the surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zehra Arslan</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kocaeli University Medical Faculty</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kocaeli University School of Medicine</name>
      <address>
        <city>Kocaeli</city>
        <zip>41900</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>November 18, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>February 2, 2017</last_update_submitted>
  <last_update_submitted_qc>February 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kocaeli University</investigator_affiliation>
    <investigator_full_name>Zehra Ipek ARSLAN</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Airtraq</keyword>
  <keyword>Intubating laryngeal mask airway</keyword>
  <keyword>BMI&gt;35</keyword>
  <!-- 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/NCT02969889
org study id: KOU KAEK 2014/137
nct id: NCT02969889
lead sponsor: 
has dmc: No
bmı > 35 morbidly obese patients requiring endotracheal intubation enrolled in this trial.
      Divided into two groups Airtraq and ILMA. their effectiveness is evaluated.
80 patients, 18-65 years of aged ASA I-III, BMI> 35 patients enrolled in this trial.

      Divided into two groups ; Airtraq and ILMA .

      BMI>35, upper airway tumour , respiratory infection less than ten days, excluded from this
      study.

      patients demographic and airway variables were recoded. Patients were premedicated. After
      standard anesthesia induction, anesthesia was induced with propofol and fentanyl. Rocuronium
      was used for neuromuscular blockade.

      The device insertion and intubation times, number of intubation attempts, mucosal damage,
      need for optimization maneuvers, effects on hemodynamic parameters and postoperative minor
      complications were recorded.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: intubation time
time frame: 1 minute
description: handling of the device till the endotracheal tube entering the glottis
arm group label: intubation time
arm group type: Active Comparator
description: handling the device till the endotracheal tube passing through the glottis
arm group label: insertion time
arm group type: Active Comparator
description: handling of the device till the glottic visualization
intervention type: Device
intervention name: Airtraq
description: video laryngoscope with a channel
arm group label: insertion time
arm group label: intubation time
intervention type: Device
intervention name: ILMA
arm group label: insertion time
arm group label: intubation time
other name: intubating laryngeal mask airway
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Zehra Arslan
role: Principal Investigator
affiliation: Kocaeli University Medical Faculty
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kocaeli University
investigator full name: Zehra Ipek ARSLAN
investigator title: Assistant Professor