<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/NCT04458064</url>
  </required_header>
  <id_info>
    <org_study_id>ASUH1421/18</org_study_id>
    <nct_id>NCT04458064</nct_id>
  </id_info>
  <brief_title>I-gel Versus Air-Q LMA for Pediatric Patients</brief_title>
  <official_title>I-gel Versus Air-Q LMA for Pediatric Patients Undergoing Short-duration Surgical Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams 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>
      This study targets to compare insertion facility, effect on hemodynamic parameters and&#xD;
      effective ventilation using i-gel versus Air-Q LMA for pediatric patients undergoing&#xD;
      short-duration surgical procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patient were divided into 2 groups. I gel group and Air Q group according to LMA type&#xD;
      used to maintain airway ventilation.&#xD;
&#xD;
      The patients were compared according to insertion facility, effect on hemodynamic parameters&#xD;
      and effective ventilation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">July 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 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>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Supraglottic device success rate</measure>
    <time_frame>60 minutes</time_frame>
    <description>Fitness of LMA for ventilation</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Easy Insertion, Complications Ans Suitability of i Gel and Air Q LMA</condition>
  <arm_group>
    <arm_group_label>i gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>I gel LMA was inserted for all patients</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Air Q LMA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Air Q LMA was inserted for all patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>LMA i gel</intervention_name>
    <description>insertion of LMA for maintaining airway during anesthesia</description>
    <arm_group_label>Air Q LMA</arm_group_label>
    <arm_group_label>i gel</arm_group_label>
    <other_name>LMA Air Q</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA grade I-II&#xD;
&#xD;
          -  operative time of ≤60 minutes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &gt;10 years&#xD;
&#xD;
          -  ASA grade ≥II&#xD;
&#xD;
          -  current or recently resolved upper respiratory tract infection&#xD;
&#xD;
          -  presence of oropharynx or laryngeal pathologies or congenital anomalies&#xD;
&#xD;
          -  pathologies inducing reflux or increasing the possibility of aspiration&#xD;
&#xD;
          -  allergy to anaesthetic or drugs to be used, renal, cardiac or hepatic diseases, or&#xD;
             bronchial asthma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ain Shams University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 1, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Ayman Anis Metry</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT04458064
org study id: ASUH1421/18
nct id: NCT04458064
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study targets to compare insertion facility, effect on hemodynamic parameters and
      effective ventilation using i-gel versus Air-Q LMA for pediatric patients undergoing
      short-duration surgical procedures.
The patient were divided into 2 groups. I gel group and Air Q group according to LMA type
      used to maintain airway ventilation.

      The patients were compared according to insertion facility, effect on hemodynamic parameters
      and effective ventilation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Supraglottic device success rate
time frame: 60 minutes
description: Fitness of LMA for ventilation
arm group label: i gel
arm group type: Active Comparator
description: I gel LMA was inserted for all patients
arm group label: Air Q LMA
arm group type: Active Comparator
description: Air Q LMA was inserted for all patients
intervention type: Other
intervention name: LMA i gel
description: insertion of LMA for maintaining airway during anesthesia
arm group label: Air Q LMA
arm group label: i gel
other name: LMA Air Q
criteria: 
gender: All
minimum age: 3 Years
maximum age: 10 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Ayman Anis Metry
investigator title: Assistant professor