xml: <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/NCT05974488</url>
    </required_header>
    <id_info>
      <org_study_id>20221246</org_study_id>
      <nct_id>NCT05974488</nct_id>
    </id_info>
    <brief_title>The Efficacy of Distal Pharyngeal Airway for Oxygenation During TEE</brief_title>
    <official_title>The Efficacy of Distal Pharyngeal Airway in Enhancing Oxygenation During Transesophageal Echocardiography (TEE) in Patients Sedated With Propofol</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Miami</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Miami</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to investigate the effect of using the McMurray Enhanced Airway&#xD;
        (MEA) which is a flexible extended-length distal pharyngeal airway on improving oxygen&#xD;
        delivery compared to standard nasal cannula.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</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>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of hypoxia</measure>
      <time_frame>during procedure (up to 60 minutes)</time_frame>
      <description>Determine the incidence of hypoxia defined as oxygen saturation by pulse oximetry (SPo2)= 75-89%.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of subclinical hypoxia</measure>
      <time_frame>during procedure (up to 60 minutes)</time_frame>
      <description>Determine the incidence of subclinical hypoxia defined as SPo2= 90-95%.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of severe Hypoxia</measure>
      <time_frame>during procedure (up to 60 minutes)</time_frame>
      <description>Determine the incidence of severe hypoxia defined as SPo2&lt;75%.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Airway Obstruction</condition>
    <arm_group>
      <arm_group_label>Distal Pharyngeal Airway</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants in this group will use the McMurray enhanced airway to have oxygen delivered throughout a TEE procedure for up to 60 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Nasal cannula group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participant in this group will receive oxygen through a nasal cannula during the TEE procedure for up to 60 minutes.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>McMurray Enhanced Airway</intervention_name>
      <description>The MEA is non-sterile. It can be used in inpatient or outpatient surgery, in hospital or clinic settings, or in an emergency setting. The MEA has five parts: an optional 15 mm connector, flange (color-coded for size), elongated cushioned bite block, flexible cannula, and distal tip, and a channel to allow for passage of air and a suction catheter. The MEA is designed to open and maintain a patient's upper airway. Oxygen will be delivered through the breathing circuit with the following parameters: 40% oxygen at 6 liters/min flow throughout the procedure time. The MEA will be placed in the participant's oropharyngeal airway one time during an in-person visit.</description>
      <arm_group_label>Distal Pharyngeal Airway</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Nasal Cannula</intervention_name>
      <description>Participants in this group will use the nasal cannula to deliver oxygen as per standard of care one time during the in-person visit.</description>
      <arm_group_label>Nasal cannula group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt; or = 18 years old&#xD;
  &#xD;
            -  Patients willing to participate and provide an informed consent&#xD;
  &#xD;
            -  Patients scheduled to undergo an elective TEE procedure.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with history of uncontrolled gastroesophageal reflux disease&#xD;
  &#xD;
            -  Patients with anatomical airway obstruction&#xD;
  &#xD;
            -  Have any condition that, in the opinion of the investigator, would compromise the&#xD;
               well-being of the patient or the study or prevent the patient from meeting or&#xD;
               performing study requirements&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fouad G Souki, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Miami</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fouad G Souki, MD</last_name>
      <phone>(305) 5857435</phone>
      <email>fsouki@med.miami.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Jackson Memorial Hospital</name>
        <address>
          <city>Miami</city>
          <state>Florida</state>
          <zip>33136</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Fouad G Souki, MD</last_name>
        <phone>305-585-7435</phone>
        <email>fsouki@miami.edu</email>
      </contact>
      <investigator>
        <last_name>Fouad G Souki, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 31, 2023</study_first_submitted>
    <study_first_submitted_qc>July 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Miami</investigator_affiliation>
      <investigator_full_name>Fouad souki</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Airway Obstruction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05974488
  org study id: 20221246
  nct id: NCT05974488
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The purpose of this study is to investigate the effect of using the McMurray Enhanced Airway
        (MEA) which is a flexible extended-length distal pharyngeal airway on improving oxygen
        delivery compared to standard nasal cannula.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Incidence of hypoxia
  time frame: during procedure (up to 60 minutes)
  description: Determine the incidence of hypoxia defined as oxygen saturation by pulse oximetry (SPo2)= 75-89%.
  measure: Incidence of subclinical hypoxia
  time frame: during procedure (up to 60 minutes)
  description: Determine the incidence of subclinical hypoxia defined as SPo2= 90-95%.
  measure: Incidence of severe Hypoxia
  time frame: during procedure (up to 60 minutes)
  description: Determine the incidence of severe hypoxia defined as SPo2<75%.
  arm group label: Distal Pharyngeal Airway
  arm group type: Experimental
  description: Participants in this group will use the McMurray enhanced airway to have oxygen delivered throughout a TEE procedure for up to 60 minutes.
  arm group label: Nasal cannula group
  arm group type: Active Comparator
  description: Participant in this group will receive oxygen through a nasal cannula during the TEE procedure for up to 60 minutes.
  intervention type: Device
  intervention name: McMurray Enhanced Airway
  description: The MEA is non-sterile. It can be used in inpatient or outpatient surgery, in hospital or clinic settings, or in an emergency setting. The MEA has five parts: an optional 15 mm connector, flange (color-coded for size), elongated cushioned bite block, flexible cannula, and distal tip, and a channel to allow for passage of air and a suction catheter. The MEA is designed to open and maintain a patient's upper airway. Oxygen will be delivered through the breathing circuit with the following parameters: 40% oxygen at 6 liters/min flow throughout the procedure time. The MEA will be placed in the participant's oropharyngeal airway one time during an in-person visit.
  arm group label: Distal Pharyngeal Airway
  intervention type: Device
  intervention name: Nasal Cannula
  description: Participants in this group will use the nasal cannula to deliver oxygen as per standard of care one time during the in-person visit.
  arm group label: Nasal cannula group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Fouad G Souki, MD
  role: Principal Investigator
  affiliation: University of Miami
  last name: Fouad G Souki, MD
  phone: (305) 5857435
  email: fsouki@med.miami.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Miami
  investigator full name: Fouad souki
  investigator title: Associate Professor
  mesh term: Airway Obstruction
  sharing ipd: No