<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/NCT03759990</url>
  </required_header>
  <id_info>
    <org_study_id>KOU-KAEK 2018 - 202</org_study_id>
    <nct_id>NCT03759990</nct_id>
  </id_info>
  <brief_title>Tracheal Intubation in Morbidly Obese (BMI&gt;35) and in Lean (BMI&lt;30) Patients Using McGrath MAC X-Blade</brief_title>
  <official_title>A Comparison of Morbidly Obese and Lean</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      80 lean (BMI&lt;35) and morbidly obese (BMI&gt;35) patients undergoing elective surgery were&#xD;
      enrolled in this prospective ransomİzed study were intubated using McGrath MAC X-Blade. The&#xD;
      demographic and airway variables of patients and insertion and intubation times with these&#xD;
      dievices, need for optimisation maneuvers, hemodynamic changes and minör postoperative&#xD;
      complications were recorded.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      80 lean (BMI&lt;35) and morbidly obese (BMI&gt;35) patients undergoing elective surgery were&#xD;
      enrolled in this prospective ransomİzed study were intubated using McGrath MAC X-Blade. The&#xD;
      demographic and airway variables of patients were recorded. Airway management variables&#xD;
      Cormack-Lehan grades, insertion and intubation times, need for optimization maneuvers (&#xD;
      cricoid pressure, re-inserting, drawback) , hemodynamic changes in heart rate , blood&#xD;
      pressure and minor postoperative complications such as sore throat, dysphasia, hoarseness&#xD;
      were recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2018</start_date>
  <completion_date type="Actual">December 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 1, 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>intubation time</measure>
    <time_frame>2 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Obesity, Morbid</condition>
  <arm_group>
    <arm_group_label>insertion time</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>intubation time</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>lean</intervention_name>
    <description>Videolaryngoscope used in intubation</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>obese</intervention_name>
    <description>Videolaryngoscope used in intubation</description>
    <arm_group_label>insertion time</arm_group_label>
    <arm_group_label>intubation time</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: &gt; 18 age &lt;65 age&#xD;
&#xD;
          -  bmı 35&#xD;
&#xD;
               -  undergoing elective surgery requiring endotracheal intubation&#xD;
&#xD;
        Exclusion Criteria: -pregnant&#xD;
&#xD;
          -  &lt;18 and &gt;65 years of age&#xD;
&#xD;
          -  bmı&lt;35&#xD;
&#xD;
          -  upper respiratory tract infection past ten days&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Kocaeli University School of Medicine</name>
      <address>
        <city>Kocaeli</city>
        <zip>41900</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kocaeli University Medical Faculty</name>
      <address>
        <city>Kocaeli</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>March 3, 2020</last_update_submitted>
  <last_update_submitted_qc>March 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2020</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>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>videolaryngoscope</keyword>
  <keyword>Airtraq</keyword>
  <keyword>McGrath MAC</keyword>
  <keyword>Morbid obesity</keyword>
  <keyword>intubation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <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/NCT03759990
org study id: KOU-KAEK 2018 - 202
nct id: NCT03759990
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
80 lean (BMI<35) and morbidly obese (BMI>35) patients undergoing elective surgery were
      enrolled in this prospective ransomİzed study were intubated using McGrath MAC X-Blade. The
      demographic and airway variables of patients and insertion and intubation times with these
      dievices, need for optimisation maneuvers, hemodynamic changes and minör postoperative
      complications were recorded.
80 lean (BMI<35) and morbidly obese (BMI>35) patients undergoing elective surgery were
      enrolled in this prospective ransomİzed study were intubated using McGrath MAC X-Blade. The
      demographic and airway variables of patients were recorded. Airway management variables
      Cormack-Lehan grades, insertion and intubation times, need for optimization maneuvers (
      cricoid pressure, re-inserting, drawback) , hemodynamic changes in heart rate , blood
      pressure and minor postoperative complications such as sore throat, dysphasia, hoarseness
      were recorded.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Double (Participant, Outcomes Assessor)
measure: intubation time
time frame: 2 months
arm group label: insertion time
arm group type: Active Comparator
arm group label: intubation time
arm group type: Active Comparator
intervention type: Device
intervention name: lean
description: Videolaryngoscope used in intubation
arm group label: insertion time
arm group label: intubation time
intervention type: Device
intervention name: obese
description: Videolaryngoscope used in intubation
arm group label: insertion time
arm group label: intubation time
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Kocaeli University
investigator full name: Zehra Ipek ARSLAN
investigator title: Associate Professor
mesh term: Obesity, Morbid
sharing ipd: No