<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/NCT03816969</url>
  </required_header>
  <id_info>
    <org_study_id>N 1- 2018/Ms</org_study_id>
    <nct_id>NCT03816969</nct_id>
  </id_info>
  <brief_title>Self-pressurized Air-Q With Blocker and Air-Q Blocker in Low Risk Female Patients Undergoing Ambulatory Surgery</brief_title>
  <official_title>A Prospective Randomized Comparative Study Between the Self-pressurized Air-Q With Blocker and Air-Q Blocker 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>
    <has_dmc>Yes</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>
      In this study investigators shall compare between the two types of air-Q 's; the Air-Q ILA&#xD;
      blocker and the Air-Q SP with blocker , regarding good sealing and oropharyngeal leak&#xD;
      pressure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Air-Q family has introduced many improved designs, among which the Air- Q blocker&#xD;
      intubating laryngeal airway (Air-Q ILA blocker) in 2011. It has all the previously mentioned&#xD;
      advantages, and in addition, a new, built-in, soft guide channel that accepts regular Nasal&#xD;
      Gastric (NG) tubes to suction or optional Blocker Tubes for accessing the posterior pharynx&#xD;
      and managing the esophagus. investigators can suction the pharynx or suction, vent and block&#xD;
      the upper esophagus. Ever since the idea of SAD has launched and applying an optimum&#xD;
      intra-cuff pressure that maintains enough sealing and at the same time not injurious to the&#xD;
      oropharyngeal mucosa concerns anesthesiologists A good seal will provide good ventilation,&#xD;
      will guarantee the desired depth of anesthesia at lower gas flows and with lesser leaks to&#xD;
      the esophagus, it will not cause rise in intragastric pressure thus preventing regurgitation&#xD;
      However When the cuff pressure is more than the mucosal perfusion pressure, it is likely to&#xD;
      either cause postoperative pharyngo-laryngeal symptoms (sore throat, dysphagia, dysphonia) or&#xD;
      cause local mucosal trauma and nerve injuries Therefore, in 2013 another improvised design of&#xD;
      the Air-Q family has evolved, a Self-pressurized Air Q (air-Q SP) with blocker) . It has a&#xD;
      drain tube through which a suction tube is passed like the Air-QILA blocker , And Instead of&#xD;
      the pilot balloon and inflating cuff, the air-Q SP with blocker incorporates a&#xD;
      self-regulating periglottic cuff at the end of this tube, a communication orifice at the&#xD;
      junction of the peri-glottic cuff and the airway tube. This communication between two spaces&#xD;
      enables the cuff to dynamically regulate intra-cuff pressure depending on airway pressure.&#xD;
      This distinguishing feature of the air-Q SP may result in reduced risk for airway morbidities&#xD;
      related to cuff hyperinflation. In this study investigators shall compare between the two&#xD;
      types of air-Q 's; the Air-Q ILA blocker and the Air-Q SP with blocker , regarding good&#xD;
      sealing and oropharyngeal leak pressure&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2018</start_date>
  <completion_date type="Actual">January 18, 2019</completion_date>
  <primary_completion_date type="Actual">January 10, 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>
    <intervention_model_description>It has a drain tube through which a suction tube is passed like the Air-QILA blocker, and Instead of the pilot balloon and inflating cuff, the air-Q SP with blocker incorporates a self-regulating periglottic cuff at the end of this tube, a communication orifice at the junction of the peri-glottic 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.</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <masking_description>An online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into the study groups. Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator assessing study outcomes will all be blinded to the study groups allocation.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Oropharyngeal leak pressure</measure>
    <time_frame>10 Minutes after initial assessment</time_frame>
    <description>The Oropharyngeal leak pressure after insertion and fixation of the device</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Insertion time</measure>
    <time_frame>10 Minutes</time_frame>
    <description>time of insertion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications associated</measure>
    <time_frame>24 hours</time_frame>
    <description>Hypoxemia (SpO2 &lt;90%), intra and postoperative</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Ambulatory Surgery</condition>
  <arm_group>
    <arm_group_label>Self-pressurized air-Q with blocker</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Self-pressurized air-Q with blocker has a greater seal pressure compared to Air-Q blocker, easier and faster in insertion and has less morbidity and complications while and after insertion</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Air-Q ILA blocker</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>It has a drain tube through which a suction tube is passed</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Self-pressurized air-Q with blocker</intervention_name>
    <description>It has a drain tube through which a suction tube is passed like the Air-QILA blocker, and Instead of the pilot balloon and inflating cuff, the air-Q SP with blocker incorporates a self-regulating periglottic cuff at the end of this tube , a communication orifice at the junction of the peri-glottic cuff and the airway tube.&#xD;
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</description>
    <arm_group_label>Self-pressurized air-Q with blocker</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Air-Q ILA blocker</intervention_name>
    <description>A good seal will provide good ventilation, will guarantee the desired depth of anesthesia at lower gas flows and with lesser leaks to the esophagus, it will not cause rise in intragastric pressure thus preventing regurgitation However, When the cuff pressure is more than the mucosal perfusion pressure, it is likely to either cause postoperative pharyngo-laryngeal symptoms (sore throat, dysphagia, dysphonia) or cause local mucosal trauma and nerve injuries</description>
    <arm_group_label>Air-Q ILA blocker</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female patients between the age group of 18 and 50 years.&#xD;
&#xD;
          2. Patients of American Society of Anaesthesiologists (ASA) class I and II.&#xD;
&#xD;
          3. Patients with Ganzouri airway score less than 4.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. ASA III - V patients.&#xD;
&#xD;
          2. Airway score ≥ 4 according to El-Ganzouri Airway Scoring System.&#xD;
&#xD;
          3. Patients with any oropharyngeal pathology.&#xD;
&#xD;
          4. 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>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Abdalla Mohamed, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ahmed Abdalla Mohamed</name>
      <address>
        <city>Cairo</city>
        <zip>11451</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>July 23, 2021</last_update_submitted>
  <last_update_submitted_qc>July 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Abdalla</investigator_full_name>
    <investigator_title>Professor of Anesthesia &amp;I.C.U and Pain Clinic, Cairo University</investigator_title>
  </responsible_party>
  <keyword>Self-pressurized Air Q</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Till Press</ipd_description>
  </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/NCT03816969
org study id: N 1- 2018/Ms
nct id: NCT03816969
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this study investigators shall compare between the two types of air-Q 's; the Air-Q ILA
      blocker and the Air-Q SP with blocker , regarding good sealing and oropharyngeal leak
      pressure
The Air-Q family has introduced many improved designs, among which the Air- Q blocker
      intubating laryngeal airway (Air-Q ILA blocker) in 2011. It has all the previously mentioned
      advantages, and in addition, a new, built-in, soft guide channel that accepts regular Nasal
      Gastric (NG) tubes to suction or optional Blocker Tubes for accessing the posterior pharynx
      and managing the esophagus. investigators can suction the pharynx or suction, vent and block
      the upper esophagus. Ever since the idea of SAD has launched and applying an optimum
      intra-cuff pressure that maintains enough sealing and at the same time not injurious to the
      oropharyngeal mucosa concerns anesthesiologists A good seal will provide good ventilation,
      will guarantee the desired depth of anesthesia at lower gas flows and with lesser leaks to
      the esophagus, it will not cause rise in intragastric pressure thus preventing regurgitation
      However When the cuff pressure is more than the mucosal perfusion pressure, it is likely to
      either cause postoperative pharyngo-laryngeal symptoms (sore throat, dysphagia, dysphonia) or
      cause local mucosal trauma and nerve injuries Therefore, in 2013 another improvised design of
      the Air-Q family has evolved, a Self-pressurized Air Q (air-Q SP) with blocker) . It has a
      drain tube through which a suction tube is passed like the Air-QILA blocker , And Instead of
      the pilot balloon and inflating cuff, the air-Q SP with blocker incorporates a
      self-regulating periglottic cuff at the end of this tube, a communication orifice at the
      junction of the peri-glottic 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. In this study investigators shall compare between the two
      types of air-Q 's; the Air-Q ILA blocker and the Air-Q SP with blocker , regarding good
      sealing and oropharyngeal leak pressure
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: It has a drain tube through which a suction tube is passed like the Air-QILA blocker, and Instead of the pilot balloon and inflating cuff, the air-Q SP with blocker incorporates a self-regulating periglottic cuff at the end of this tube, a communication orifice at the junction of the peri-glottic 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.
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
masking description: An online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into the study groups. Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator assessing study outcomes will all be blinded to the study groups allocation.
measure: Oropharyngeal leak pressure
time frame: 10 Minutes after initial assessment
description: The Oropharyngeal leak pressure after insertion and fixation of the device
measure: Insertion time
time frame: 10 Minutes
description: time of insertion
measure: Complications associated
time frame: 24 hours
description: Hypoxemia (SpO2 <90%), intra and postoperative
arm group label: Self-pressurized air-Q with blocker
arm group type: Active Comparator
description: Self-pressurized air-Q with blocker has a greater seal pressure compared to Air-Q blocker, easier and faster in insertion and has less morbidity and complications while and after insertion
arm group label: Air-Q ILA blocker
arm group type: Active Comparator
description: It has a drain tube through which a suction tube is passed
intervention type: Device
intervention name: Self-pressurized air-Q with blocker
description: It has a drain tube through which a suction tube is passed like the Air-QILA blocker, and Instead of the pilot balloon and inflating cuff, the air-Q SP with blocker incorporates a self-regulating periglottic cuff at the end of this tube , a communication orifice at the junction of the peri-glottic 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
arm group label: Self-pressurized air-Q with blocker
intervention type: Device
intervention name: Air-Q ILA blocker
description: A good seal will provide good ventilation, will guarantee the desired depth of anesthesia at lower gas flows and with lesser leaks to the esophagus, it will not cause rise in intragastric pressure thus preventing regurgitation However, When the cuff pressure is more than the mucosal perfusion pressure, it is likely to either cause postoperative pharyngo-laryngeal symptoms (sore throat, dysphagia, dysphonia) or cause local mucosal trauma and nerve injuries
arm group label: Air-Q ILA blocker
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ahmed Abdalla Mohamed, M.D
role: Principal Investigator
affiliation: Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Abdalla
investigator title: Professor of Anesthesia &I.C.U and Pain Clinic, Cairo University
sharing ipd: Undecided
ipd description: Till Press