<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/NCT04419883</url>
  </required_header>
  <id_info>
    <org_study_id>MEA-001-01</org_study_id>
    <nct_id>NCT04419883</nct_id>
  </id_info>
  <brief_title>A New Flexible Extended-Length Pharyngeal Airway for Deep Sedation</brief_title>
  <official_title>Provider Satisfaction of a New, Flexible Extended-Length Pharyngeal Airway to Relieve Upper Airway Obstructive During Deep Sedation: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>McMurray Medical Group, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>McMurray Medical Group, LLC</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 prospective pilot provider adoption study was to evaluate user experience&#xD;
      a new airway device in adult patients with airway obstruction under deep sedation. Fifteen&#xD;
      hospital systems served as testing sites. Fifty-four anaesthetist providers reported their&#xD;
      experience with the airway device in 84 cases across two phases of surveying.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This multi-center proof-of-concept, descriptive, prospective, and observational study was&#xD;
      approved by a universal Institutional Review Board (IRB) for Human Subjects Research in March&#xD;
      2019. Anaesthesia providers who volunteered to trial this new airway device were recruited to&#xD;
      complete a survey tool to assess provider satisfaction of a commercially-available upper&#xD;
      airway device (McMurray Enhanced Airway (MEA); McMurray Medical, Minneapolis, MN).&#xD;
&#xD;
      The MEA is a novel upper airway device with numerous enhanced features relative to currently&#xD;
      available airway management products (Figure 1). The MEA has longer flexible tubing allowing&#xD;
      for displacement of pharyngeal tissue that oral airways are unable to reach, and avoiding the&#xD;
      need for chin lift/jaw thrust maneuvers [16]. The smaller diameter helps reduce stimulation&#xD;
      and gagging and permits placement alongside an endoscopy bite block. The softer material,&#xD;
      similar to that of a nasal airway, allows for ease of insertion and reduces potential oral&#xD;
      injury associated with hard plastic oral airways [16]. An elongated cushioned bite block is&#xD;
      designed to prevent proximal airway collapse, allow flexibility of molar placement, and&#xD;
      decrease the risk of dental damage [16]. An optional connector can be connected to an&#xD;
      anesthesia circuit or manual resuscitator, facilitating intraoral ventilation and aiding in&#xD;
      situations such as difficult mask ventilation or when oxygen diffusion in the surgical field&#xD;
      may present fire risk [16]. Furthermore, the MEA was designed to reduce need for manual&#xD;
      stationary maneuvers by providers such as chin lift or jaw thrust, thereby preventing&#xD;
      potential provider-patient exposure of airborne droplets and increased staffing.&#xD;
&#xD;
      Providers received device instructions for use (IFU) by training video and printed material&#xD;
      to understand how to use and size the MEA. After using the MEA trial device in clinical&#xD;
      practice, anaesthesia providers participated in completing the Use Survey Tool based on cases&#xD;
      meeting the following criteria: inclusion criteria included adult patients (age &gt;18)&#xD;
      experiencing an obstructive airway under deep sedation; exclusion criteria included&#xD;
      determining that the device size was inappropriate-too big or small-for the patient, since&#xD;
      placing an improper size could be detrimental for the patient.&#xD;
&#xD;
      The initial survey(Phase 1) was developed to evaluate current product usage, general use&#xD;
      conditions, deep sedation conditions, general anaesthesia conditions, device performance, and&#xD;
      overall device satisfaction using binary responses with option for subjective free response.&#xD;
      Based on Phase 1 responses and provider feedback, Phase 2 surveys were limited to questions&#xD;
      with ordinal responses that assessed device use satisfaction during deep sedation procedures&#xD;
      only. Surveys were distributed with the trial devices. As this was a pilot feasibility study&#xD;
      for the new extended pharyngeal airway device, recruitment of provider subjects was based on&#xD;
      interest of using a novel airway device to benefit airway management when providing deep&#xD;
      sedation in situations where airway obstruction became problematic. Surveys were voluntarily&#xD;
      completed by the anaesthesia provider following each use. One provider could complete&#xD;
      multiple surveys to represent individual device performance and experience. Information&#xD;
      related to patient, provider, and device placement frequency was not collected in order to&#xD;
      expedite response rate to learn initial provider experience. Submitted surveys underwent&#xD;
      response analysis by an independent statistician. Due to the nature of qualitative data,&#xD;
      descriptive statistics were used to summarize study results. No objective measures of device&#xD;
      clinical efficacy were collected.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 5, 2019</start_date>
  <completion_date type="Actual">May 5, 2020</completion_date>
  <primary_completion_date type="Actual">March 5, 2020</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>Evaluate the new, flexible extended-length pharyngeal airway ease of use</measure>
    <time_frame>Survey was completed immediately after completion of surgery and airway use</time_frame>
    <description>The question asked: With the curve end facing the hard palate, how easy was the MEA to place? Four response options on measurement tool to assess outcomes: Easy, Moderate, Difficult, Not Successful</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess the new, flexible extended-length pharyngeal ability to relieve an upper airway obstruction</measure>
    <time_frame>Survey was completed immediately after completion of surgery and airway use</time_frame>
    <description>Two response options on measurement tool to assess outcomes: Yes and No</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess if the new airway allowed a &quot;hands off approach&quot; when the patient was under deep sedation/MAC anesthesia</measure>
    <time_frame>Survey was completed immediately after completion of surgery and airway use</time_frame>
    <description>Three response options on measurement tool to assess outcomes: Yes, No, Not sure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Provider satisfaction with the new, flexible extended-length pharyngeal airway.</measure>
    <time_frame>Survey was completed immediately after completion of surgery and airway use</time_frame>
    <description>Five response options on measurement tool to assess outcomes: Very Satisfied, Somewhat Satisfied, Satisfied, Dissatisfied, I did not use the MEA for deep MAC</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">86</enrollment>
  <condition>Upper Airway Obstruction</condition>
  <arm_group>
    <arm_group_label>Anesthesia Providers</arm_group_label>
    <description>Anesthesia providers from 15 different health care facilities in the United States.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>McMurray Enhanced Airway</intervention_name>
    <description>Provider Satisfaction of a New, Flexible Extended-Length Pharyngeal Airway to Relieve Upper Airway Obstructive During Deep Sedation: A Pilot Study</description>
    <arm_group_label>Anesthesia Providers</arm_group_label>
    <other_name>MEA</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Anesthesia providers who volunteered to trial this new airway device were recruited to&#xD;
        complete a survey tool to assess provider satisfaction of a commercially-available upper&#xD;
        airway device (McMurray Enhanced Airway (MEA); McMurray Medical, Minneapolis, MN).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age and older&#xD;
&#xD;
          -  Scheduled for surgery with sedation/MAC anesthesia&#xD;
&#xD;
          -  Patients experiencing an obstructive airway needing an airway device placed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        • Inappropriate airway device size, too big or too small&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Roxanne McMurray, DNP</last_name>
    <role>Principal Investigator</role>
    <affiliation>McMurray Medical Group, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Roxanne McMurray</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 29, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>McMurray Medical Group, LLC</investigator_affiliation>
    <investigator_full_name>Roxanne R McMurray</investigator_full_name>
    <investigator_title>VP of Clinical Management</investigator_title>
  </responsible_party>
  <keyword>Upper airway obstruction</keyword>
  <keyword>Airway management tools</keyword>
  <keyword>Airway complications</keyword>
  <keyword>Deep sedation</keyword>
  <keyword>Deep monitored anaesthesia care (MAC)</keyword>
  <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>
    <ipd_description>No individual participant data was collected for this study</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/NCT04419883
org study id: MEA-001-01
nct id: NCT04419883
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this prospective pilot provider adoption study was to evaluate user experience
      a new airway device in adult patients with airway obstruction under deep sedation. Fifteen
      hospital systems served as testing sites. Fifty-four anaesthetist providers reported their
      experience with the airway device in 84 cases across two phases of surveying.
This multi-center proof-of-concept, descriptive, prospective, and observational study was
      approved by a universal Institutional Review Board (IRB) for Human Subjects Research in March
      2019. Anaesthesia providers who volunteered to trial this new airway device were recruited to
      complete a survey tool to assess provider satisfaction of a commercially-available upper
      airway device (McMurray Enhanced Airway (MEA); McMurray Medical, Minneapolis, MN).

      The MEA is a novel upper airway device with numerous enhanced features relative to currently
      available airway management products (Figure 1). The MEA has longer flexible tubing allowing
      for displacement of pharyngeal tissue that oral airways are unable to reach, and avoiding the
      need for chin lift/jaw thrust maneuvers [16]. The smaller diameter helps reduce stimulation
      and gagging and permits placement alongside an endoscopy bite block. The softer material,
      similar to that of a nasal airway, allows for ease of insertion and reduces potential oral
      injury associated with hard plastic oral airways [16]. An elongated cushioned bite block is
      designed to prevent proximal airway collapse, allow flexibility of molar placement, and
      decrease the risk of dental damage [16]. An optional connector can be connected to an
      anesthesia circuit or manual resuscitator, facilitating intraoral ventilation and aiding in
      situations such as difficult mask ventilation or when oxygen diffusion in the surgical field
      may present fire risk [16]. Furthermore, the MEA was designed to reduce need for manual
      stationary maneuvers by providers such as chin lift or jaw thrust, thereby preventing
      potential provider-patient exposure of airborne droplets and increased staffing.

      Providers received device instructions for use (IFU) by training video and printed material
      to understand how to use and size the MEA. After using the MEA trial device in clinical
      practice, anaesthesia providers participated in completing the Use Survey Tool based on cases
      meeting the following criteria: inclusion criteria included adult patients (age >18)
      experiencing an obstructive airway under deep sedation; exclusion criteria included
      determining that the device size was inappropriate-too big or small-for the patient, since
      placing an improper size could be detrimental for the patient.

      The initial survey(Phase 1) was developed to evaluate current product usage, general use
      conditions, deep sedation conditions, general anaesthesia conditions, device performance, and
      overall device satisfaction using binary responses with option for subjective free response.
      Based on Phase 1 responses and provider feedback, Phase 2 surveys were limited to questions
      with ordinal responses that assessed device use satisfaction during deep sedation procedures
      only. Surveys were distributed with the trial devices. As this was a pilot feasibility study
      for the new extended pharyngeal airway device, recruitment of provider subjects was based on
      interest of using a novel airway device to benefit airway management when providing deep
      sedation in situations where airway obstruction became problematic. Surveys were voluntarily
      completed by the anaesthesia provider following each use. One provider could complete
      multiple surveys to represent individual device performance and experience. Information
      related to patient, provider, and device placement frequency was not collected in order to
      expedite response rate to learn initial provider experience. Submitted surveys underwent
      response analysis by an independent statistician. Due to the nature of qualitative data,
      descriptive statistics were used to summarize study results. No objective measures of device
      clinical efficacy were collected.
observational model: Cohort
time perspective: Prospective
measure: Evaluate the new, flexible extended-length pharyngeal airway ease of use
time frame: Survey was completed immediately after completion of surgery and airway use
description: The question asked: With the curve end facing the hard palate, how easy was the MEA to place? Four response options on measurement tool to assess outcomes: Easy, Moderate, Difficult, Not Successful
measure: Assess the new, flexible extended-length pharyngeal ability to relieve an upper airway obstruction
time frame: Survey was completed immediately after completion of surgery and airway use
description: Two response options on measurement tool to assess outcomes: Yes and No
measure: Assess if the new airway allowed a "hands off approach" when the patient was under deep sedation/MAC anesthesia
time frame: Survey was completed immediately after completion of surgery and airway use
description: Three response options on measurement tool to assess outcomes: Yes, No, Not sure
measure: Provider satisfaction with the new, flexible extended-length pharyngeal airway.
time frame: Survey was completed immediately after completion of surgery and airway use
description: Five response options on measurement tool to assess outcomes: Very Satisfied, Somewhat Satisfied, Satisfied, Dissatisfied, I did not use the MEA for deep MAC
arm group label: Anesthesia Providers
description: Anesthesia providers from 15 different health care facilities in the United States.
intervention type: Device
intervention name: McMurray Enhanced Airway
description: Provider Satisfaction of a New, Flexible Extended-Length Pharyngeal Airway to Relieve Upper Airway Obstructive During Deep Sedation: A Pilot Study
arm group label: Anesthesia Providers
other name: MEA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Roxanne McMurray, DNP
role: Principal Investigator
affiliation: McMurray Medical Group, LLC
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: McMurray Medical Group, LLC
investigator full name: Roxanne R McMurray
investigator title: VP of Clinical Management
mesh term: Airway Obstruction
sharing ipd: No
ipd description: No individual participant data was collected for this study