<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/NCT03798392</url>
  </required_header>
  <id_info>
    <org_study_id>N-24- 2018</org_study_id>
    <nct_id>NCT03798392</nct_id>
  </id_info>
  <brief_title>Self-pressurised Air-Q With Blocker Versus Baska Mask in Low Risk Female Patients Undergoing Ambulatory Surgery.</brief_title>
  <official_title>A Randomized Comparison of Self-pressurized Air-Q With Blocker With Baska Mask Supraglottic Airway in Low Risk Female Patients Undergoing Ambulatory Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Supraglottic airway devices (SGAs) are very commonly used during anesthesia but structural&#xD;
      vulnerability to airway morbidity and issues about cuff pressure still concern&#xD;
      anesthesiologists. There have been controversial results regarding optimal intra-cuff&#xD;
      pressure in various types of cuffed supraglottic airways. When the supraglottic cuff pressure&#xD;
      is more than the mucosal perfusion pressure, it is likely to either cause postoperative&#xD;
      pharyngo-laryngeal symptoms like sore throat (dysphagia, dysphonia) or cause local mucosal&#xD;
      trauma and nerve injuries. Supraglottic airway devices with non-inﬂatable cuff have&#xD;
      advantages in omitting the cuff pressure monitoring and reducing potential pharyngo-laryngeal&#xD;
      complications.&#xD;
&#xD;
      Self-pressurizing Air Q blocker is the latest version. It has a drain tube through which a&#xD;
      suction tube is passed. There is an inflatable cuff at the end of this tube. On inflation,&#xD;
      the cuff seals the esophageal opening into the stomach, preventing any regurgitation of&#xD;
      stomach contents. Instead of the pilot balloon and inﬂating cuff, the air-Q SP with blocker&#xD;
      has a communication oriﬁce at the junction of the peri-glotic cuff and the airway tube. This&#xD;
      communication between two spaces enables the cuff to dynamically regulate intra-cuff pressure&#xD;
      depending on airway pressure. This distinguishing feature of the air-Q SP may result in&#xD;
      reduced risk for airway morbidities related to cuff hyperinﬂation.&#xD;
&#xD;
      The Baska mask is a novel supraglottic airway device with a non-inﬂatable cuff, an&#xD;
      oesophageal drainage inlet and side channels to facilitate aspiration of gastric contents,&#xD;
      and an integrated bite-block. It was revealed that the baska mask is relatively easy to&#xD;
      insert, provided a high-quality seal with the glotic aperture and the incidence of throat&#xD;
      discomfort appeared low.&#xD;
&#xD;
      To our knowledge, and after searching in previous literature, no previous studies have&#xD;
      compared the Air-Q SP with blocker with Baska mask; another supraglottic airway devices with&#xD;
      non-inﬂatable cuff.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2019</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>airway seal pressure 10 minutes after insertion</measure>
    <time_frame>10 minutes after the device insertion.</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">62</enrollment>
  <condition>Supraglottic Airway Devices</condition>
  <arm_group>
    <arm_group_label>SP group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Baska group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Self-pressurizing Air Q blocker mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion</intervention_name>
    <description>comparing the airway seal pressure 10 min after insertion of each devices .</description>
    <arm_group_label>SP group</arm_group_label>
    <other_name>airway management under general anesthesia</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Baska mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion</intervention_name>
    <description>comparing the airway seal pressure 10 min after insertion of each devices .</description>
    <arm_group_label>Baska group</arm_group_label>
    <other_name>airway management under general anesthesia</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female patients between the age group of 18 and 50 years,&#xD;
&#xD;
          -  ASA class I and II,&#xD;
&#xD;
          -  undergoing elective surgeries,&#xD;
&#xD;
          -  with Ganzouri airway score less than 4&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA III - V patients.&#xD;
&#xD;
          -  Airway score ≥ 4 according to El-Ganzouri Airway Scoring System.&#xD;
&#xD;
          -  Patients with respiratory or pharyngeal pathology.&#xD;
&#xD;
          -  Patients allergic to any drugs in the protocol.&#xD;
&#xD;
          -  Obese patients with body mass index ≥ 40.&#xD;
&#xD;
          -  Patients known to have risk of gastric aspiration, gastro-esophageal reflux disease,&#xD;
             hiatus hernia or previous upper gastrointestinal tract surgery.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Abeer Ahmed, MD</last_name>
    <phone>01005244590</phone>
    <email>abeer_ahmed@kasralainy.edu.eg</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kasr Alainy Faculty of Medicine - Cairo university</name>
      <address>
        <city>Cairo</city>
        <zip>00225</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abeer Ahmed, Assistant Professor</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</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>Assistant Professor of Anesthesia, SICU and pain management - kasr Aiainy Faculty of Medicine - Cairo University</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>
  <!-- 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/NCT03798392
org study id: N-24- 2018
nct id: NCT03798392
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
Supraglottic airway devices (SGAs) are very commonly used during anesthesia but structural
      vulnerability to airway morbidity and issues about cuff pressure still concern
      anesthesiologists. There have been controversial results regarding optimal intra-cuff
      pressure in various types of cuffed supraglottic airways. When the supraglottic cuff pressure
      is more than the mucosal perfusion pressure, it is likely to either cause postoperative
      pharyngo-laryngeal symptoms like sore throat (dysphagia, dysphonia) or cause local mucosal
      trauma and nerve injuries. Supraglottic airway devices with non-inﬂatable cuff have
      advantages in omitting the cuff pressure monitoring and reducing potential pharyngo-laryngeal
      complications.

      Self-pressurizing Air Q blocker is the latest version. It has a drain tube through which a
      suction tube is passed. There is an inflatable cuff at the end of this tube. On inflation,
      the cuff seals the esophageal opening into the stomach, preventing any regurgitation of
      stomach contents. Instead of the pilot balloon and inﬂating cuff, the air-Q SP with blocker
      has a communication oriﬁce at the junction of the peri-glotic cuff and the airway tube. This
      communication between two spaces enables the cuff to dynamically regulate intra-cuff pressure
      depending on airway pressure. This distinguishing feature of the air-Q SP may result in
      reduced risk for airway morbidities related to cuff hyperinﬂation.

      The Baska mask is a novel supraglottic airway device with a non-inﬂatable cuff, an
      oesophageal drainage inlet and side channels to facilitate aspiration of gastric contents,
      and an integrated bite-block. It was revealed that the baska mask is relatively easy to
      insert, provided a high-quality seal with the glotic aperture and the incidence of throat
      discomfort appeared low.

      To our knowledge, and after searching in previous literature, no previous studies have
      compared the Air-Q SP with blocker with Baska mask; another supraglottic airway devices with
      non-inﬂatable cuff.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: airway seal pressure 10 minutes after insertion
time frame: 10 minutes after the device insertion.
arm group label: SP group
arm group type: Active Comparator
arm group label: Baska group
arm group type: Active Comparator
intervention type: Device
intervention name: Self-pressurizing Air Q blocker mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion
description: comparing the airway seal pressure 10 min after insertion of each devices .
arm group label: SP group
other name: airway management under general anesthesia
intervention type: Device
intervention name: Baska mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion
description: comparing the airway seal pressure 10 min after insertion of each devices .
arm group label: Baska group
other name: airway management under general anesthesia
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Abeer Ahmed, MD
phone: 01005244590
email: abeer_ahmed@kasralainy.edu.eg
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Abeer Ahmed, MD
investigator title: Assistant Professor of Anesthesia, SICU and pain management - kasr Aiainy Faculty of Medicine - Cairo University
mesh term: Anesthetics