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/NCT05989880</url>
    </required_header>
    <id_info>
      <org_study_id>HSC-MS-23-0537</org_study_id>
      <nct_id>NCT05989880</nct_id>
    </id_info>
    <brief_title>Pilot Feasibility Trial of the SafeLM Supraglottic Airway (SGA)</brief_title>
    <official_title>Pilot Feasibility Trial of the SafeLM Supraglottic Airway</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Texas Health Science Center, Houston</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>The University of Texas Health Science Center, Houston</source>
    <oversight_info>
      <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 assess the feasibility of SafeLM as a primary airway device&#xD;
        and as a conduit for intubation with and without the use of a bougie&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">October 2, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 2, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Intubation success rate</measure>
      <time_frame>at the time of intubation</time_frame>
      <description>This is assessed by the ability of the SafeLM to achieve adequate oxygenation and ventilation via the respective procedure once the airway device is in place.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Number of insertion attempts required to achieve effective oxygenation and ventilation</measure>
      <time_frame>at the time of intubation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to insertion</measure>
      <time_frame>at the time of intubation</time_frame>
      <description>This is measured by the time from opening the mouth to the time of end tidal CO2 on capnography</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Subjective ease of insertion of the airway device</measure>
      <time_frame>at the time of intubation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety of the SafeLM as an SGA</measure>
      <time_frame>at the time of intubation</time_frame>
      <description>This will be assessed by the number of adverse events such as airway obstruction, aspiration, and hypoxia.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Safety of the SafeLM as a conduit for intubation</measure>
      <time_frame>at the time of intubation</time_frame>
      <description>This will be assessed by the number of adverse events such as esophageal intubation, bronchial intubation, and hypoxia during the intubation process.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Anesthesia</condition>
    <arm_group>
      <arm_group_label>SafeLM as a supraglottic airway device with video capability</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>SafeLM as a supraglottic airway device without video capability</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>SafeLM as a conduit for intubation using an endotracheal tube with video capability</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>SafeLM as a conduit for intubation using a bougie with video capability</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SafeLM as a supraglottic airway device with video capability</intervention_name>
      <description>The device will be inserted using the video capability and used as a primary airway device for the duration of the surgical procedure. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening. The position of the device will be confirmed by observing the video image of the glottis on the monitor. The adequacy of ventilation and oxygenation will be assessed by monitoring the patient's end-tidal CO2, pulse oximetry, and clinical signs of effective ventilation. Leak and cuff pressure will be assessed. The device will be removed at the end of the surgical procedure or if there are any signs of device malfunction, airway obstruction, or inadequate ventilation.</description>
      <arm_group_label>SafeLM as a supraglottic airway device with video capability</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SafeLM as a supraglottic airway device without video capability</intervention_name>
      <description>The device will be blindly inserted without using the video capability and used as a primary airway device for the duration of the surgical procedure. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening. The position of the device will be confirmed by observing the video image of the glottis on the monitor. The adequacy of ventilation and oxygenation will be assessed by monitoring the patient's end-tidal CO2, pulse oximetry, and clinical signs of effective ventilation. Leak and cuff pressure will be assessed. The video capability of the device will be used to assess the accuracy of placement after the fact. The device will be removed at the end of the surgical procedure or if there are any signs of device malfunction, airway obstruction, or inadequate ventilation.</description>
      <arm_group_label>SafeLM as a supraglottic airway device without video capability</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SafeLM as a conduit for intubation using an endotracheal tube with video capability</intervention_name>
      <description>The device will be inserted, and an endotracheal tube will be advanced through the device under direct visualization using the video capability of the device. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening. The endotracheal tube will be introduced through the working channel of the SafeLM under direct visualization using the video capability of the device. The endotracheal tube will be advanced into the trachea, and the position will be confirmed by end-tidal carbon dioxide (EtCO2) detection and chest auscultation. The cuff of the endotracheal tube will be inflated, and mechanical ventilation will be resumed. The SafeLM device will be removed, and the position of the endotracheal tube will be confirmed once again.</description>
      <arm_group_label>SafeLM as a conduit for intubation using an endotracheal tube with video capability</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>SafeLM as a conduit for intubation using a bougie with video capability</intervention_name>
      <description>The device will be inserted. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening.The position of the device will be confirmed by observing the video image of the glottis on the monitor. The video camera on the SafeLM will be turned on to visualize the vocal cords.A standard airway bougie will be introduced through the working channel of the SafeLM under direct visualization using the video capability of the device.The SafeLM device will be removed, and an appropriately sized endotracheal tube will be advanced into the trachea. If a bougie is not able to be inserted into the tracheal under direct visualization, direct insertion of an endotracheal tube into the trachea will be attempted, followed by flexible scope intubation.</description>
      <arm_group_label>SafeLM as a conduit for intubation using a bougie with video capability</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  elective surgery requiring general anesthesia and airway management using a&#xD;
               supraglottic airway device or endotracheal intubation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pregnancy&#xD;
  &#xD;
            -  known or suspected difficult airway management&#xD;
  &#xD;
            -  history of oropharyngeal or upper airway surgery&#xD;
  &#xD;
            -  known or suspected airway or respiratory pathology, such as significant obstructive&#xD;
               sleep apnea or chronic obstructive pulmonary disease (COPD)&#xD;
  &#xD;
            -  BMI greater than 40 kg/m2&#xD;
  &#xD;
            -  unable to undergo intubation via the oral route&#xD;
  &#xD;
            -  known or suspected full stomach or other risk factors for aspiration&#xD;
  &#xD;
            -  contraindication for the use of neuromuscular blocking agents&#xD;
  &#xD;
            -  history of significant gastroesophageal reflux disease (GERD)&#xD;
  &#xD;
            -  Vulnerable populations (cognitively impaired persons, prisoners)&#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>Lauren M Nakazawa, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Texas Health Science Center, Houston</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Lauren M Nakazawa, MD</last_name>
      <phone>713-500-6775</phone>
      <email>Lauren.M.Nakazawa@uth.tmc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Carlos Artime, MD</last_name>
      <phone>713-500-6171</phone>
      <email>Carlos.Artime@uth.tmc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The University of Texas Health Science Center at Houston</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Lauren M Nakazawa, MD</last_name>
        <phone>713-500-6775</phone>
        <email>Lauren.M.Nakazawa@uth.tmc.edu</email>
      </contact>
      <contact_backup>
        <last_name>Carlos Artime, MD</last_name>
        <phone>713-500-6171</phone>
        <email>Carlos.Artime@uth.tmc.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 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>The University of Texas Health Science Center, Houston</investigator_affiliation>
      <investigator_full_name>Lauren Nakazawa</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <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/NCT05989880
  org study id: HSC-MS-23-0537
  nct id: NCT05989880
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The purpose of this study is to assess the feasibility of SafeLM as a primary airway device
        and as a conduit for intubation with and without the use of a bougie
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Intubation success rate
  time frame: at the time of intubation
  description: This is assessed by the ability of the SafeLM to achieve adequate oxygenation and ventilation via the respective procedure once the airway device is in place.
  measure: Number of insertion attempts required to achieve effective oxygenation and ventilation
  time frame: at the time of intubation
  measure: Time to insertion
  time frame: at the time of intubation
  description: This is measured by the time from opening the mouth to the time of end tidal CO2 on capnography
  measure: Subjective ease of insertion of the airway device
  time frame: at the time of intubation
  measure: Safety of the SafeLM as an SGA
  time frame: at the time of intubation
  description: This will be assessed by the number of adverse events such as airway obstruction, aspiration, and hypoxia.
  measure: Safety of the SafeLM as a conduit for intubation
  time frame: at the time of intubation
  description: This will be assessed by the number of adverse events such as esophageal intubation, bronchial intubation, and hypoxia during the intubation process.
  arm group label: SafeLM as a supraglottic airway device with video capability
  arm group type: Experimental
  arm group label: SafeLM as a supraglottic airway device without video capability
  arm group type: Experimental
  arm group label: SafeLM as a conduit for intubation using an endotracheal tube with video capability
  arm group type: Experimental
  arm group label: SafeLM as a conduit for intubation using a bougie with video capability
  arm group type: Experimental
  intervention type: Device
  intervention name: SafeLM as a supraglottic airway device with video capability
  description: The device will be inserted using the video capability and used as a primary airway device for the duration of the surgical procedure. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening. The position of the device will be confirmed by observing the video image of the glottis on the monitor. The adequacy of ventilation and oxygenation will be assessed by monitoring the patient's end-tidal CO2, pulse oximetry, and clinical signs of effective ventilation. Leak and cuff pressure will be assessed. The device will be removed at the end of the surgical procedure or if there are any signs of device malfunction, airway obstruction, or inadequate ventilation.
  arm group label: SafeLM as a supraglottic airway device with video capability
  intervention type: Device
  intervention name: SafeLM as a supraglottic airway device without video capability
  description: The device will be blindly inserted without using the video capability and used as a primary airway device for the duration of the surgical procedure. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening. The position of the device will be confirmed by observing the video image of the glottis on the monitor. The adequacy of ventilation and oxygenation will be assessed by monitoring the patient's end-tidal CO2, pulse oximetry, and clinical signs of effective ventilation. Leak and cuff pressure will be assessed. The video capability of the device will be used to assess the accuracy of placement after the fact. The device will be removed at the end of the surgical procedure or if there are any signs of device malfunction, airway obstruction, or inadequate ventilation.
  arm group label: SafeLM as a supraglottic airway device without video capability
  intervention type: Device
  intervention name: SafeLM as a conduit for intubation using an endotracheal tube with video capability
  description: The device will be inserted, and an endotracheal tube will be advanced through the device under direct visualization using the video capability of the device. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening. The endotracheal tube will be introduced through the working channel of the SafeLM under direct visualization using the video capability of the device. The endotracheal tube will be advanced into the trachea, and the position will be confirmed by end-tidal carbon dioxide (EtCO2) detection and chest auscultation. The cuff of the endotracheal tube will be inflated, and mechanical ventilation will be resumed. The SafeLM device will be removed, and the position of the endotracheal tube will be confirmed once again.
  arm group label: SafeLM as a conduit for intubation using an endotracheal tube with video capability
  intervention type: Device
  intervention name: SafeLM as a conduit for intubation using a bougie with video capability
  description: The device will be inserted. Once the device is in place, the cuff will be inflated with the recommended volume of air to ensure an adequate seal around the laryngeal opening.The position of the device will be confirmed by observing the video image of the glottis on the monitor. The video camera on the SafeLM will be turned on to visualize the vocal cords.A standard airway bougie will be introduced through the working channel of the SafeLM under direct visualization using the video capability of the device.The SafeLM device will be removed, and an appropriately sized endotracheal tube will be advanced into the trachea. If a bougie is not able to be inserted into the tracheal under direct visualization, direct insertion of an endotracheal tube into the trachea will be attempted, followed by flexible scope intubation.
  arm group label: SafeLM as a conduit for intubation using a bougie with video capability
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lauren M Nakazawa, MD
  role: Principal Investigator
  affiliation: The University of Texas Health Science Center, Houston
  last name: Lauren M Nakazawa, MD
  phone: 713-500-6775
  email: Lauren.M.Nakazawa@uth.tmc.edu
  last name: Carlos Artime, MD
  phone: 713-500-6171
  email: Carlos.Artime@uth.tmc.edu
  facility: 
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The University of Texas Health Science Center, Houston
  investigator full name: Lauren Nakazawa
  investigator title: Assistant Professor
  sharing ipd: No