<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/NCT04453683</url>
  </required_header>
  <id_info>
    <org_study_id>Intubation in morbid obese</org_study_id>
    <nct_id>NCT04453683</nct_id>
  </id_info>
  <brief_title>Airway Management in Morbidly Obese Patients: A Comparison of Intubating Laryngeal Mask Fastrack and Air Q as a Conduit for Fiberoptic Intubation</brief_title>
  <official_title>Airway Management in Morbidly Obese Patients: A Comparison of Intubating Laryngeal Mask Fastrack and Air Q as a Conduit for Fiberoptic Intubation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Zagazig University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Zagazig University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare air Q versus ILMA intubation in obese adult paralyzed patient&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Evaluate the process of endo-tracheal intubation through Air Q compared to through ILMA&#xD;
      regarding number and duration of attempts, laryngeal view grade, time to removal of device&#xD;
      over tube without dislodgement and any complication&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 20, 2019</start_date>
  <completion_date type="Actual">June 20, 2020</completion_date>
  <primary_completion_date type="Actual">June 20, 2020</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>success rate of tracheal intubation through each device.</measure>
    <time_frame>Within a maximum of 5 minutes to confirm success of tracheal intubation through each supraglottic airway devices</time_frame>
    <description>success rate of tracheal intubation through each device is defined as end tidal carbon dioxide confirmed placement of TT within a maximum of 5 min tracheal intubation time</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insertion time of supraglottic airway devices</measure>
    <time_frame>It is about 13-19 second for insertion of supraglottic airway devices</time_frame>
    <description>Time necessary for insertion was measured from the time the face mask was taken away until the appearance of Co2 on the capnograph while supraglottic airway device in place</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Intubation; Difficult or Failed</condition>
  <arm_group>
    <arm_group_label>Group I ( Air Q)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>nsertion of proper size Air-Q. ILA</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II (ILMA)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>nsertion of proper size ILMA</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Air-Q. ILA insertion of proper size</intervention_name>
    <description>Success of fiberoptic guided intubation throuhgh Air Q supraglottic airway device</description>
    <arm_group_label>Group I ( Air Q)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ILMA insertion of proper size</intervention_name>
    <description>Success of fiberoptic guided intubation throuhgh ILMA supraglottic airway device</description>
    <arm_group_label>Group II (ILMA)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:All morbidly obese patient defined as BMI &gt;40 kg/m2 scheduled for an&#xD;
        elective surgery requiring general anesthesia with tracheal intubation were enrolled on the&#xD;
        day of their surgery.&#xD;
&#xD;
        ASA physical status (I-II)&#xD;
&#xD;
        Exclusion Criteria physical status of IV or V or had a history of impossible tracheal&#xD;
        intubation or awake fibreoptic intubation or if preoperative evaluation showed limited&#xD;
        mouth aperture &lt;3.5 cm or showed evidence that an awake fiberoptic intubation or rapid&#xD;
        sequence induction would be required patients at increased risk for aspiration of gastric&#xD;
        contents, coagulopathy or those with unstable cervical spines or requiring nasal route for&#xD;
        tracheal intubation&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heba M EL-Asser, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zagazig University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Khadiga M El Hossiney, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Zagazig University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Amani A Aly</last_name>
    <role>Study Chair</role>
    <affiliation>Zagazig University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zagazig University</name>
      <address>
        <city>Zagazig</city>
        <zip>002055</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Frappier J, Guenoun T, Journois D, Philippe H, Aka E, Cadi P, Silleran-Chassany J, Safran D. Airway management using the intubating laryngeal mask airway for the morbidly obese patient. Anesth Analg. 2003 May;96(5):1510-1515. doi: 10.1213/01.ANE.0000057003.91393.3C.</citation>
    <PMID>12707159</PMID>
  </reference>
  <reference>
    <citation>Karim YM, Swanson DE. Comparison of blind tracheal intubation through the intubating laryngeal mask airway (LMA Fastrach) and the Air-Q. Anaesthesia. 2011 Mar;66(3):185-90. doi: 10.1111/j.1365-2044.2011.06625.x.</citation>
    <PMID>21320087</PMID>
  </reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>January 2, 2023</last_update_submitted>
  <last_update_submitted_qc>January 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Zagazig University</investigator_affiliation>
    <investigator_full_name>Heba Mohamed EL -Asser,MD</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/NCT04453683
org study id: Intubation in morbid obese
nct id: NCT04453683
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To compare air Q versus ILMA intubation in obese adult paralyzed patient
Evaluate the process of endo-tracheal intubation through Air Q compared to through ILMA
      regarding number and duration of attempts, laryngeal view grade, time to removal of device
      over tube without dislodgement and any complication
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
measure: success rate of tracheal intubation through each device.
time frame: Within a maximum of 5 minutes to confirm success of tracheal intubation through each supraglottic airway devices
description: success rate of tracheal intubation through each device is defined as end tidal carbon dioxide confirmed placement of TT within a maximum of 5 min tracheal intubation time
measure: Insertion time of supraglottic airway devices
time frame: It is about 13-19 second for insertion of supraglottic airway devices
description: Time necessary for insertion was measured from the time the face mask was taken away until the appearance of Co2 on the capnograph while supraglottic airway device in place
arm group label: Group I ( Air Q)
arm group type: Active Comparator
description: nsertion of proper size Air-Q. ILA
arm group label: Group II (ILMA)
arm group type: Active Comparator
description: nsertion of proper size ILMA
intervention type: Device
intervention name: Air-Q. ILA insertion of proper size
description: Success of fiberoptic guided intubation throuhgh Air Q supraglottic airway device
arm group label: Group I ( Air Q)
intervention type: Device
intervention name: ILMA insertion of proper size
description: Success of fiberoptic guided intubation throuhgh ILMA supraglottic airway device
arm group label: Group II (ILMA)
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Heba M EL-Asser, MD
role: Principal Investigator
affiliation: Zagazig University
last name: Khadiga M El Hossiney, MD
role: Study Chair
affiliation: Zagazig University
last name: Amani A Aly
role: Study Chair
affiliation: Zagazig University
facility: 
country: Egypt
citation: Frappier J, Guenoun T, Journois D, Philippe H, Aka E, Cadi P, Silleran-Chassany J, Safran D. Airway management using the intubating laryngeal mask airway for the morbidly obese patient. Anesth Analg. 2003 May;96(5):1510-1515. doi: 10.1213/01.ANE.0000057003.91393.3C.
PMID: 12707159
citation: Karim YM, Swanson DE. Comparison of blind tracheal intubation through the intubating laryngeal mask airway (LMA Fastrach) and the Air-Q. Anaesthesia. 2011 Mar;66(3):185-90. doi: 10.1111/j.1365-2044.2011.06625.x.
PMID: 21320087
responsible party type: Principal Investigator
investigator affiliation: Zagazig University
investigator full name: Heba Mohamed EL -Asser,MD
investigator title: principal investigator
sharing ipd: No