<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/NCT04421261</url>
  </required_header>
  <id_info>
    <org_study_id>KR-1990</org_study_id>
    <nct_id>NCT04421261</nct_id>
  </id_info>
  <brief_title>Ventilation With Supraglottic Airway Devices</brief_title>
  <official_title>Evaluation of Performance of Air-Q Self Pressurized Airway Device With Blocker and Proseal Laryngeal Mask Airway at Different Head and Neck Positions in Anesthetized Paralyzed Adult Female Patients Undergoing Elective Gynecological Operations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Reham Ali Abdelhaleem Abdelrahman</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>
      Airo-Q Self Pressurized airway device with Blocker will be compared with I-Gel in&#xD;
      anesthetized adult female patients undergoing elective surgeries to discuss the influence of&#xD;
      different head and neck positions on the performance of both devices. Oropharyngeal leak&#xD;
      pressure, peak inspiratory pressure, ventilation score and fiber-optic view will be assessed&#xD;
      in neutral, flexion, extension and lateral positions in both groups.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Actual">July 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>oropharyngeal leak pressure</measure>
    <time_frame>1 year</time_frame>
    <description>pressure at which air leak starts to occur</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">140</enrollment>
  <condition>Laryngeal Masks Comparison</condition>
  <arm_group>
    <arm_group_label>Air-Q Self Pressurized Airway Device with Blocker</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Proseal Laryngeal Mask Airway</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Air-Q Self Pressurized Airway Device with Blocker</intervention_name>
    <description>used in low risk adult females undergoing elective surgeries</description>
    <arm_group_label>Air-Q Self Pressurized Airway Device with Blocker</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Proseal Laryngeal Mask Airway</intervention_name>
    <description>used in low risk adult female patients undergoing elective surgeries</description>
    <arm_group_label>Proseal Laryngeal Mask Airway</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult female patients who will be admitted through outpatient clinic of Kasr alainy&#xD;
        hospitals&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult female patients ASA I&amp;II.&#xD;
&#xD;
          -  age: 18-55 years old.&#xD;
&#xD;
          -  BMI&lt; 35.&#xD;
&#xD;
          -  undergoing elective surgeries.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with history of upper respiratory tract infections and obstructive sleep&#xD;
             apnea.&#xD;
&#xD;
          -  Patients who are potentially full stomach such as trauma, pregnancy, history of&#xD;
             gastric regurgitation &amp;heart burn, those with esophageal reflux or hiatus hernia.&#xD;
&#xD;
          -  Patients with coagulation disorders.&#xD;
&#xD;
          -  Patients with El-Ganzouri airway score ≥ 5 will.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of anesthesia, Surgical ICU and Pain Management</name>
      <address>
        <city>Cairo</city>
        <zip>11562</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Reham Ali Abdelhaleem Abdelrahman</investigator_full_name>
    <investigator_title>Anesthesia 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/NCT04421261
org study id: KR-1990
nct id: NCT04421261
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Airo-Q Self Pressurized airway device with Blocker will be compared with I-Gel in
      anesthetized adult female patients undergoing elective surgeries to discuss the influence of
      different head and neck positions on the performance of both devices. Oropharyngeal leak
      pressure, peak inspiratory pressure, ventilation score and fiber-optic view will be assessed
      in neutral, flexion, extension and lateral positions in both groups.
observational model: Cohort
time perspective: Prospective
measure: oropharyngeal leak pressure
time frame: 1 year
description: pressure at which air leak starts to occur
arm group label: Air-Q Self Pressurized Airway Device with Blocker
arm group label: Proseal Laryngeal Mask Airway
intervention type: Device
intervention name: Air-Q Self Pressurized Airway Device with Blocker
description: used in low risk adult females undergoing elective surgeries
arm group label: Air-Q Self Pressurized Airway Device with Blocker
intervention type: Device
intervention name: Proseal Laryngeal Mask Airway
description: used in low risk adult female patients undergoing elective surgeries
arm group label: Proseal Laryngeal Mask Airway
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Reham Ali Abdelhaleem Abdelrahman
investigator title: Anesthesia lecturer