<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/NCT04498598</url>
  </required_header>
  <id_info>
    <org_study_id>20-163</org_study_id>
    <nct_id>NCT04498598</nct_id>
  </id_info>
  <brief_title>Structural Modification In Supraglottic Airway Device</brief_title>
  <official_title>Structural Modification In Supraglottic Airway Device Enhances Exchange Between Supraglottic &amp; Endotracheal Ventilation Modes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed A/Z modification of a supraglottic airway (SGA) incorporates an opening in the&#xD;
      SGA body that enables access to the endotracheal tube (ETT) through the body of the SGA&#xD;
      without the need of using an exchange catheter, thus enabling an ETT to move in the body of&#xD;
      the SGA and convert a supraglottic to endotracheal ventilation. In its original form an&#xD;
      adaptor made from same material currently used in the endotracheal tubes can make ventilation&#xD;
      through the proposed airway device possible in exactly the same manner of a conventional SGA&#xD;
      currently used. This adapter also known as the R-piece can be replaced with an ETT. The&#xD;
      modification also allows placement of SGA over an existing ETT to convert and endotracheal&#xD;
      (ET) to supraglottic (SG) mode of ventilation without the need to use an exchange catheter.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The special design allows conversion of a telescopic coaxial portion (R piece), replacing&#xD;
      with an ETT which can act coaxially to provide both supraglottic (up position) and&#xD;
      endotracheal (down position) of ETT. See this modification in&#xD;
      https://www.youtube.com/watch?v=iy84lALU1aI&#xD;
&#xD;
      Currently the proposed change to the conventional SGA has been made and feasibility tested on&#xD;
      Manikins. The A/Z airway modification is also demonstrated in the attached link video&#xD;
      https://www.youtube.com/watch?v=ukLOAC55iG8&#xD;
&#xD;
      In this study, we are trialing the A/Z concept on an original A/Z modification by a&#xD;
      manufacturer on their currently used SGA. Thus instead of investigators making the changes by&#xD;
      cutting a channel in a conventional SGA immediately before use in the Operating Room, they&#xD;
      have asked a manufacturer to do so professionally.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 30, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Test effect of A/Z modification of supraglottic airway device on rate of successful oxygenation and ventilation before beginning a full clinical trial</measure>
    <time_frame>During and immediately after the intervention</time_frame>
    <description>An alteration and structural modification in the supraglottic airway device can improve safety of airway exchange in patient needing general anesthesia, this proof of concept should show if the modification has any affect on oxygenation and ventilation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of successful exchange from supraglottic to endotracheal ventilation using A/Z modified SGA</measure>
    <time_frame>During and immediately after intervention</time_frame>
    <description>Evaluate if a modification of configuration on &quot;Laryngeal Mask Airway&quot; improves safety during Supraglottic to Endotracheal conversion without using an exchange catheter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of successful exchange from endotracheal to supraglottic ventilation using A/Z modified SGA</measure>
    <time_frame>During and immediately after intervention</time_frame>
    <description>Evaluate if this modification can enhance smooth extubation after endotracheal intubation by converting an endotracheal tube to a supraglottic airway</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Airway Complication of Anesthesia</condition>
  <condition>Ventilation Therapy; Complications</condition>
  <condition>Hypoxia</condition>
  <condition>Hypoventilation</condition>
  <arm_group>
    <arm_group_label>A/Z Airway</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients under general anesthesia for surgical procedures who need airway management for ventilation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>A/Z Supraglottic airway</intervention_name>
    <description>Patient receive supraglottic airway for general anesthesia which can be converted to endotracheal ventilation reversibly</description>
    <arm_group_label>A/Z Airway</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patients&#xD;
&#xD;
          2. scheduled for a general anesthesia procedure with ETT &amp; muscle relaxation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients who are not able to consent&#xD;
&#xD;
          2. Non English Speaking&#xD;
&#xD;
          3. History of difficult airway&#xD;
&#xD;
          4. Physical exam of airway which suggests difficulty in airway management or need to use&#xD;
             special equipment&#xD;
&#xD;
          5. BMI &gt;35&#xD;
&#xD;
          6. Gastroesophageal reflux disease&#xD;
&#xD;
          7. Anesthetic plan other than general anesthesia&#xD;
&#xD;
          8. Emergency procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rafi Avitsian, MD</last_name>
    <phone>216-444-9735</phone>
    <email>avitsir@ccf.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mark Mettler</last_name>
    <phone>216-445-8281</phone>
    <email>mettlem@ccf.org</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rafi Avitsian, MD</last_name>
      <phone>216-444-9735</phone>
      <email>AVITSIR@ccf.org</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://doi.org/10.1093/bja/aex213</url>
    <description>Conference Abstracts</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 13, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 14, 2023</last_update_submitted>
  <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Airway Management</keyword>
  <keyword>Oxygenation and Ventilation</keyword>
  <keyword>Airway Devices</keyword>
  <keyword>Supraglottic Airway</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoventilation</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04498598
org study id: 20-163
nct id: NCT04498598
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The proposed A/Z modification of a supraglottic airway (SGA) incorporates an opening in the
      SGA body that enables access to the endotracheal tube (ETT) through the body of the SGA
      without the need of using an exchange catheter, thus enabling an ETT to move in the body of
      the SGA and convert a supraglottic to endotracheal ventilation. In its original form an
      adaptor made from same material currently used in the endotracheal tubes can make ventilation
      through the proposed airway device possible in exactly the same manner of a conventional SGA
      currently used. This adapter also known as the R-piece can be replaced with an ETT. The
      modification also allows placement of SGA over an existing ETT to convert and endotracheal
      (ET) to supraglottic (SG) mode of ventilation without the need to use an exchange catheter.
The special design allows conversion of a telescopic coaxial portion (R piece), replacing
      with an ETT which can act coaxially to provide both supraglottic (up position) and
      endotracheal (down position) of ETT. See this modification in
      https://www.youtube.com/watch?v=iy84lALU1aI

      Currently the proposed change to the conventional SGA has been made and feasibility tested on
      Manikins. The A/Z airway modification is also demonstrated in the attached link video
      https://www.youtube.com/watch?v=ukLOAC55iG8

      In this study, we are trialing the A/Z concept on an original A/Z modification by a
      manufacturer on their currently used SGA. Thus instead of investigators making the changes by
      cutting a channel in a conventional SGA immediately before use in the Operating Room, they
      have asked a manufacturer to do so professionally.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: Test effect of A/Z modification of supraglottic airway device on rate of successful oxygenation and ventilation before beginning a full clinical trial
time frame: During and immediately after the intervention
description: An alteration and structural modification in the supraglottic airway device can improve safety of airway exchange in patient needing general anesthesia, this proof of concept should show if the modification has any affect on oxygenation and ventilation.
measure: Rate of successful exchange from supraglottic to endotracheal ventilation using A/Z modified SGA
time frame: During and immediately after intervention
description: Evaluate if a modification of configuration on "Laryngeal Mask Airway" improves safety during Supraglottic to Endotracheal conversion without using an exchange catheter
measure: Rate of successful exchange from endotracheal to supraglottic ventilation using A/Z modified SGA
time frame: During and immediately after intervention
description: Evaluate if this modification can enhance smooth extubation after endotracheal intubation by converting an endotracheal tube to a supraglottic airway
arm group label: A/Z Airway
arm group type: Experimental
description: Patients under general anesthesia for surgical procedures who need airway management for ventilation.
intervention type: Device
intervention name: A/Z Supraglottic airway
description: Patient receive supraglottic airway for general anesthesia which can be converted to endotracheal ventilation reversibly
arm group label: A/Z Airway
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Rafi Avitsian, MD
phone: 216-444-9735
email: avitsir@ccf.org
last name: Mark Mettler
phone: 216-445-8281
email: mettlem@ccf.org
facility: 
status: Recruiting
contact: 
country: United States
url: https://doi.org/10.1093/bja/aex213
description: Conference Abstracts
responsible party type: Sponsor
mesh term: Hypoventilation
mesh term: Hypoxia
sharing ipd: No