<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/NCT02226211</url>
  </required_header>
  <id_info>
    <org_study_id>N-46-2014</org_study_id>
    <nct_id>NCT02226211</nct_id>
  </id_info>
  <brief_title>Ambu Aura-i Laryngeal Mask Versus Air-Q Intubating Laryngeal Airway for Tracheal Intubation in Adults</brief_title>
  <official_title>Ambu® Aura-iTM Laryngeal Mask Versus Air-QTM Intubating Laryngeal Airway as Conduits for Tracheal Intubation in Adults. A Randomized Comparative Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Supraglottic airway devices (SGA) become a routine part of the daily anesthesia practice.&#xD;
      they can be used as primary airway devices or as conduits for endoracheal intubation and they&#xD;
      become an integral part in the recent guidelines for managing difficult airway.&#xD;
&#xD;
      Air-Q ILA has been used successfully as 1ry airway and also as a conduits for endotracheal&#xD;
      intubation.&#xD;
&#xD;
      The Ambu® Aura-i TM laryngeal mask is a new disposable SGA claimed to have special advantage&#xD;
      over the competitors but not will studied as a conduit for endoracheal intubation.&#xD;
&#xD;
      This study is designed to compare the performance of Ambu®Aura-i™ laryngeal mask with the&#xD;
      air-Q ILA as conduits for fiberoptic-guided tracheal intubation in adult population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 3</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>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>duration of fiberoptic guided insertion of the ETT through the device</measure>
    <time_frame>duration of induction of general anesthesia, an expected average of 20 minutes. and it is the time span between disconnection of the breathing circuit from the device till reconnection to the ETT and appearance of 1st capnogram wave.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>duration of device insertion</measure>
    <time_frame>duration of induction of general anesthesia, an expected average of 20 minutes and it is the time span between removal of the face mask till device insertion and the chest rise seen after two consecutive positive pressure manual breaths.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of device removal</measure>
    <time_frame>duration of induction of general anesthesia, an expected average of 20 minutes, and it is the time span between disconnection of the breathing circuit from ETT and reconnection to ETT after device removal with appearance of the 1st capnogram wave.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of insertion attempts</measure>
    <time_frame>duration of induction of general anesthesia, an expected average of 20 minutes and it is the time span from removal of face mask till complete insertion or failed third insertion trial of the device</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complication during the procedure</measure>
    <time_frame>average of 20 minutes after induction of general anesthesia, it is the time from removal of face mask, till removal of the device and appearance of the first wave on the capnogram</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vital sign in form of mean arterial blood pressure, heart rate and oxygen saturation</measure>
    <time_frame>average of 20 minutes, and it is the time from time of induction of general anesthesia til completion of endotracheal intubation</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Failed or Difficult Intubation (Anaesthesia Complications)</condition>
  <arm_group>
    <arm_group_label>air-Q group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>aura-i group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Air-Q intubation laryngeal airway</intervention_name>
    <description>The size selection of the air-Q ILA will follow the manufacture guideline to be size 3.5 for females and size 4.5 for males After induction of general anesthesia, the devices will be inserted by using midline insertion technique, then cuff will be inflated according to manufacture recommendations.&#xD;
After successful insertion of the air-Q, the appropriate endoracheal tube (ETT) will be loaded over the fiberoptic bronchoscopy, and the connector will be removed too. The bronchoscope will be introduced and advanced throughout the airway tube to just proximal to ventilating orifice, a video image of the fiberoptic view will be recorded and saved on CD to be graded later by an independent observe. The fiberoptic then will be advanced and once the carina is seen, the ETT is will be slided into the trachea.&#xD;
After successful intubation, the device will be removed according to the manufactures guides using removal stylet .</description>
    <arm_group_label>air-Q group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ambu-Aura i laryngeal mask</intervention_name>
    <description>The size selection of the device will follow the manufacture guideline according to the patient weight, size 4 for (50-70kg), size 5 (70-100) and size 6 (&gt; 100kg).&#xD;
After induction of general anesthesia, the devices will be inserted by using midline insertion technique, then cuff will be inflated according to manufacture recommendations.&#xD;
After successful insertion of the aura-i, the appropriate endoracheal tube (ETT) will be loaded over the fiberoptic bronchoscopy, and the connector will be removed too. The bronchoscope will be introduced and advanced throughout the airway tube to just proximal to ventilating orifice, a video image of the fiberoptic view will be recorded and saved on CD to be graded later by an independent observe. The fiberoptic then will be advanced and once the carina is seen, the ETT is will be slided into the trachea.&#xD;
After successful intubation, the device will be removed according to the manufactures guides using another ETT.</description>
    <arm_group_label>aura-i group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients aged from 18-60 years old, ASA I and II and scheduled for elective surgery&#xD;
             under general anesthesia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of cardiopulmonary disease, gastro-esophageal reflux disease, abnormal airway&#xD;
             anatomy, body mass index &gt; 30 kg.m-2, surgical procedures including head and neck or&#xD;
             performed in position other than supine or lithotomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Abeer Ahmed, lecturer</last_name>
    <email>abeer_ahmed@kasralainy.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>faculty of Medicine - Cairo university</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abeer Ahmed, lecturer</last_name>
      <email>abeer_ahmed@kasralainy.edu.eg</email>
    </contact>
    <investigator>
      <last_name>Abeer Ahmed, lecturer</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sherif Soaida, lecturer</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kareem Kamal, professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 22, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>August 26, 2014</last_update_submitted>
  <last_update_submitted_qc>August 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Abeer Ahmed, MD</investigator_full_name>
    <investigator_title>lecturer</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/NCT02226211
org study id: N-46-2014
nct id: NCT02226211
lead sponsor: 
has dmc: No
Supraglottic airway devices (SGA) become a routine part of the daily anesthesia practice.
      they can be used as primary airway devices or as conduits for endoracheal intubation and they
      become an integral part in the recent guidelines for managing difficult airway.

      Air-Q ILA has been used successfully as 1ry airway and also as a conduits for endotracheal
      intubation.

      The Ambu® Aura-i TM laryngeal mask is a new disposable SGA claimed to have special advantage
      over the competitors but not will studied as a conduit for endoracheal intubation.

      This study is designed to compare the performance of Ambu®Aura-i™ laryngeal mask with the
      air-Q ILA as conduits for fiberoptic-guided tracheal intubation in adult population.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: duration of fiberoptic guided insertion of the ETT through the device
time frame: duration of induction of general anesthesia, an expected average of 20 minutes. and it is the time span between disconnection of the breathing circuit from the device till reconnection to the ETT and appearance of 1st capnogram wave.
measure: duration of device insertion
time frame: duration of induction of general anesthesia, an expected average of 20 minutes and it is the time span between removal of the face mask till device insertion and the chest rise seen after two consecutive positive pressure manual breaths.
measure: Time of device removal
time frame: duration of induction of general anesthesia, an expected average of 20 minutes, and it is the time span between disconnection of the breathing circuit from ETT and reconnection to ETT after device removal with appearance of the 1st capnogram wave.
measure: number of insertion attempts
time frame: duration of induction of general anesthesia, an expected average of 20 minutes and it is the time span from removal of face mask till complete insertion or failed third insertion trial of the device
measure: complication during the procedure
time frame: average of 20 minutes after induction of general anesthesia, it is the time from removal of face mask, till removal of the device and appearance of the first wave on the capnogram
measure: vital sign in form of mean arterial blood pressure, heart rate and oxygen saturation
time frame: average of 20 minutes, and it is the time from time of induction of general anesthesia til completion of endotracheal intubation
arm group label: air-Q group
arm group type: Experimental
arm group label: aura-i group
arm group type: Experimental
intervention type: Device
intervention name: Air-Q intubation laryngeal airway
description: The size selection of the air-Q ILA will follow the manufacture guideline to be size 3.5 for females and size 4.5 for males After induction of general anesthesia, the devices will be inserted by using midline insertion technique, then cuff will be inflated according to manufacture recommendations.
After successful insertion of the air-Q, the appropriate endoracheal tube (ETT) will be loaded over the fiberoptic bronchoscopy, and the connector will be removed too. The bronchoscope will be introduced and advanced throughout the airway tube to just proximal to ventilating orifice, a video image of the fiberoptic view will be recorded and saved on CD to be graded later by an independent observe. The fiberoptic then will be advanced and once the carina is seen, the ETT is will be slided into the trachea.
After successful intubation, the device will be removed according to the manufactures guides using removal stylet .
arm group label: air-Q group
intervention type: Device
intervention name: Ambu-Aura i laryngeal mask
description: The size selection of the device will follow the manufacture guideline according to the patient weight, size 4 for (50-70kg), size 5 (70-100) and size 6 (> 100kg).
After induction of general anesthesia, the devices will be inserted by using midline insertion technique, then cuff will be inflated according to manufacture recommendations.
After successful insertion of the aura-i, the appropriate endoracheal tube (ETT) will be loaded over the fiberoptic bronchoscopy, and the connector will be removed too. The bronchoscope will be introduced and advanced throughout the airway tube to just proximal to ventilating orifice, a video image of the fiberoptic view will be recorded and saved on CD to be graded later by an independent observe. The fiberoptic then will be advanced and once the carina is seen, the ETT is will be slided into the trachea.
After successful intubation, the device will be removed according to the manufactures guides using another ETT.
arm group label: aura-i group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Abeer Ahmed, lecturer
email: abeer_ahmed@kasralainy.edu.eg
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Abeer Ahmed, MD
investigator title: lecturer