<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/NCT03247803</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0542</org_study_id>
    <nct_id>NCT03247803</nct_id>
  </id_info>
  <brief_title>Air-Q® SP Versus Williams Intubating Airway for Single-Operator FOI</brief_title>
  <official_title>Comparison of Use of a Shortened Air-Q® Self-Pressurizing Intubating Laryngeal Airway Versus the Williams Intubating Airway for Single-Operator Flexible Bronchoscopic Intubation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Wisconsin, Madison</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The air-Q and air-Q SP are commercially-available supraglottic airways (SGAs) that can be&#xD;
      used for primary airway maintenance or as a conduit for FOI, as can be the Williams,&#xD;
      Ovassapian, and Berman Intubating Airways. The air-Q products have the same overall&#xD;
      geometrical design, but differ in their cuff inflating mechanisms, where the air-Q uses a&#xD;
      traditional pilot balloon valve, while the air-Q SP utilizes a self-inflating cuff that&#xD;
      dynamically adjusts according to the relative resistances to airflow between the patient's&#xD;
      lungs and the device's cuff. The purpose of this study is to compare the single-operator&#xD;
      intubation success using the air-Q SP versus the Williams Intubating Airway as a conduit for&#xD;
      flexible bronchoscopic intubation (FBI) and to compare the single-operator intubation success&#xD;
      using the air-Q SP versus the Williams Intubating Airway as a conduit for flexible&#xD;
      bronchoscopic intubation. Both devices are commercially-available and being used in the study&#xD;
      in accordance with their labeled intended use. The investigator envisage that the endpoint of&#xD;
      the study will be single operator intubation success rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite the introduction of videolaryngoscopes, flexible bronchoscopic intubation (FBI), also&#xD;
      known as fiberoptic intubation (FOI), remains a critical method for achieving tracheal&#xD;
      intubation in patients with difficult airways. Unfortunately, however, FOI often requires&#xD;
      two-operators for success. One operator is required to manipulate the flexible bronchoscope&#xD;
      through the patient's upper airway and into their trachea, while the second operator applies&#xD;
      one or more maneuvers (e.g., jaw thrust, anterior jaw lift, or lingual retraction) with or&#xD;
      without the use of a commercially-available fiberoptic intubating airway.&#xD;
&#xD;
      Previous studies have demonstrated the effectiveness of the currently available FIAs, but&#xD;
      also illustrate the frequent need for an assistant for successful FOI. In this study, an&#xD;
      assistant performed a jaw lift and a chin lift in all subjects as well.&#xD;
&#xD;
      The air-Q and air-Q SP are commercially-available supraglottic airways (SGAs) that can be&#xD;
      used for primary airway maintenance or as a conduit for FOI, as can be the Williams,&#xD;
      Ovassapian, and Berman Intubating Airways. The air-Q products have the same overall&#xD;
      geometrical design, but differ in their cuff inflating mechanisms, where the air-Q uses a&#xD;
      traditional pilot balloon valve, while the air-Q SP utilizes a self-inflating cuff that&#xD;
      dynamically adjusts according to the relative resistances to airflow between the patient's&#xD;
      lungs and the device's cuff. In prior trials comparing the air-Q and air-Q SP with the two&#xD;
      other commercially-available SGAs, the air-Q and air-Q SP bowl design provided a partial or&#xD;
      full view of the vocal cords in 80-92% of subjects without requiring any additional airway&#xD;
      maneuvers applied by an assistant (e.g., jaw thrust, anterior jaw lift, or lingual&#xD;
      retraction) (Galgon, 2011; Galgon, 2015). Presumably, in these situations, successful&#xD;
      tracheal intubation using the air-Q or air-Q SP could have been achieved by a single operator&#xD;
      versus requiring one or more assistants. However, this potential performance advantage has&#xD;
      not yet been tested. Therefore, the purpose of this study is to compare use of the air-Q SP&#xD;
      against the WA for FBI performed by a single operator.&#xD;
&#xD;
      The air-Q SP, rather than the air-Q, is chosen for this study because its lack of a pilot&#xD;
      balloon valve allows its stem to be easily shortened to ease device removal over the&#xD;
      coaxially placed tracheal tube. The WA is chosen for this study because it has performed best&#xD;
      in past trials and is the airway routinely used by the study principal investigator (PI) for&#xD;
      FBI. Both devices are commercially-available and being used in the study in accordance with&#xD;
      their labeled intended use.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 11, 2018</start_date>
  <completion_date type="Actual">March 8, 2019</completion_date>
  <primary_completion_date type="Actual">March 8, 2019</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>
    <intervention_model_description>Adult patients presenting for a surgical or interventional procedure requiring general anesthesia and tracheal intubation, who do not meet any of the study exclusion criteria, and who give their informed consent, will be randomly allocated to receive either an air-Q SP or Williams Intubating Airway as a conduit to aid flexible bronchoscopic intubation.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Each study subject will be blinded to the study device they receive; however, the anesthesia provider will not be blinded to the study device and will have access to all monitors deemed appropriate by the primary anesthesia team caring for the subject.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>The primary endpoint is single-operator intubation success.</measure>
    <time_frame>15 minutes</time_frame>
    <description>The primary purpose of this study is to compare the single-operator intubation success using the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time required for conduit placement</measure>
    <time_frame>15 minutes</time_frame>
    <description>The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time required for each intubation attempt</measure>
    <time_frame>15 minutes</time_frame>
    <description>The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall intubation time</measure>
    <time_frame>15 minutes</time_frame>
    <description>The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of attempts required for conduit placement</measure>
    <time_frame>15 minutes</time_frame>
    <description>The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of attempts for successful intubation</measure>
    <time_frame>15 minutes</time_frame>
    <description>The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number and types of assistive airway maneuvers (e.g., jaw thrust, lingual retraction, etc.) for successful intubation</measure>
    <time_frame>15 minutes</time_frame>
    <description>The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Successful intubation method</measure>
    <time_frame>15 minutes</time_frame>
    <description>The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tracheal tube dislodgment rate during conduit removal</measure>
    <time_frame>15 minutes</time_frame>
    <description>The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen desaturation rate</measure>
    <time_frame>15 minutes</time_frame>
    <description>The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative sore throat rate.</measure>
    <time_frame>4 hours</time_frame>
    <description>The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Intubation; Difficult or Failed</condition>
  <condition>Laryngeal Masks</condition>
  <arm_group>
    <arm_group_label>Air-Q SP</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>air-Q Self-Pressurizing intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mecury Medical, Clearwater, FL, USA)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Williams Intubating Airway</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Airway Intubator, Williams, Adult Female, Single Use, Molded Surlyn Plastic, 9 cm or Airway Intubator, Williams, Adult Male, Single Use, Molded Surlyn Plastic, 10 cm</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>air-Q® SP</intervention_name>
    <description>air-Q SP placement for airway maintenance,</description>
    <arm_group_label>Air-Q SP</arm_group_label>
    <other_name>air-Q SP placement for airway maintenance</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Williams Airway Intubator (WA)</intervention_name>
    <description>WA is placed in subject's oropharynx. If the vocal cords are not in view at the end of the WA, the operator may ask an assistant to perform an airway maneuver (e.g., jaw thrust, anterior jaw lift, or lingual traction) to attempt to bring the vocal cords into view</description>
    <arm_group_label>Williams Intubating Airway</arm_group_label>
    <other_name>WA is placed in subject's oropharynx.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patients (≥18 years);&#xD;
&#xD;
          2. The patient is scheduled for an elective surgery or procedure that will take place in&#xD;
             the UWHC main operating room, outpatient surgical center, or ambulatory procedure&#xD;
             center; and&#xD;
&#xD;
          3. The patient's primary anesthesia care team has planned for general anesthesia with&#xD;
             orotracheal intubation for airway maintenance.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. The patient is &lt; 18 years of age;&#xD;
&#xD;
          2. The patient is non-English speaking;&#xD;
&#xD;
          3. The patient is known or believed to be pregnant;&#xD;
&#xD;
          4. The patient is a prisoner;&#xD;
&#xD;
          5. The patient has impaired decision-making capacity;&#xD;
&#xD;
          6. The patient is at increased risk for aspiration, including non-fasted or emergency&#xD;
             surgery, and cases of uncontrolled gastroesophageal reflux disease, hiatal hernia,&#xD;
             gastroparesis, esophageal dysmotility, prior esophagectomy, and/or emesis within&#xD;
             twenty-four hours of the surgery or procedure;&#xD;
&#xD;
          7. The patient has limited mouth opening or oropharyngeal anatomy making successful&#xD;
             placement of the study airway conduit unlikely;&#xD;
&#xD;
          8. The patient has airway exam features, a medical condition, or a past airway management&#xD;
             history, which prompts the attending anesthesiologist to plan to maintain spontaneous&#xD;
             ventilation during tracheal intubation;&#xD;
&#xD;
          9. The patient pre-operatively is requiring supplemental oxygen;&#xD;
&#xD;
         10. The patient has moderate to severe cardiac disease, as evidenced by a left ventricular&#xD;
             ejection fraction of ≤ 50% on the most recent echocardiogram, severe aortic valve&#xD;
             stenosis, atrial fibrillation with a resting pre-operative heart rate of ≥ 90 beats&#xD;
             per minute, and/or known, multi-vessel coronary artery, managed conservatively with&#xD;
             medical management or by intervention with multiple coronary artery stents or coronary&#xD;
             bypass grafting; and&#xD;
&#xD;
         11. The patient has an allergy to glycopyrrolate.&#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>Richard E Galgon, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Anesthesiology,University of Wisconsin, Madison, Wisconsin, United States, 53792</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin Hopital and Clinics</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pubmed/21880031?dopt=Abstract</url>
    <description>Galgon RE, Schroeder KM, Han S, et al. The air-Q(®) intubating laryngeal airway vs the LMA-ProSeal(TM) : a prospective, randomised trial of airway seal pressure. Anaesthesia. 2011 Dec;66(12):1093-100.</description>
  </link>
  <reference>
    <citation>Galgon RE, Schroeder KM, Han S, Andrei A, Joffe AM. The air-Q((R)) intubating laryngeal airway vs the LMA-ProSeal(TM) : a prospective, randomised trial of airway seal pressure. Anaesthesia. 2011 Dec;66(12):1093-100. doi: 10.1111/j.1365-2044.2011.06863.x. Epub 2011 Aug 22.</citation>
    <PMID>21880031</PMID>
  </reference>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>March 20, 2019</last_update_submitted>
  <last_update_submitted_qc>March 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Air-Q® SP</keyword>
  <keyword>Williams Airway Intubator (WA)</keyword>
  <keyword>Flexible Bronchoscopic intubation (FBI)</keyword>
  <keyword>Fiberoptic Intubation (FOI)</keyword>
  <keyword>Fiberoptic Intubating Airway(FIA)</keyword>
  <keyword>Laryngeal Mask Airway</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>There is no plan to make individual participant data available to other researchers.</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/NCT03247803
org study id: 2017-0542
nct id: NCT03247803
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The air-Q and air-Q SP are commercially-available supraglottic airways (SGAs) that can be
      used for primary airway maintenance or as a conduit for FOI, as can be the Williams,
      Ovassapian, and Berman Intubating Airways. The air-Q products have the same overall
      geometrical design, but differ in their cuff inflating mechanisms, where the air-Q uses a
      traditional pilot balloon valve, while the air-Q SP utilizes a self-inflating cuff that
      dynamically adjusts according to the relative resistances to airflow between the patient's
      lungs and the device's cuff. The purpose of this study is to compare the single-operator
      intubation success using the air-Q SP versus the Williams Intubating Airway as a conduit for
      flexible bronchoscopic intubation (FBI) and to compare the single-operator intubation success
      using the air-Q SP versus the Williams Intubating Airway as a conduit for flexible
      bronchoscopic intubation. Both devices are commercially-available and being used in the study
      in accordance with their labeled intended use. The investigator envisage that the endpoint of
      the study will be single operator intubation success rate.
Despite the introduction of videolaryngoscopes, flexible bronchoscopic intubation (FBI), also
      known as fiberoptic intubation (FOI), remains a critical method for achieving tracheal
      intubation in patients with difficult airways. Unfortunately, however, FOI often requires
      two-operators for success. One operator is required to manipulate the flexible bronchoscope
      through the patient's upper airway and into their trachea, while the second operator applies
      one or more maneuvers (e.g., jaw thrust, anterior jaw lift, or lingual retraction) with or
      without the use of a commercially-available fiberoptic intubating airway.

      Previous studies have demonstrated the effectiveness of the currently available FIAs, but
      also illustrate the frequent need for an assistant for successful FOI. In this study, an
      assistant performed a jaw lift and a chin lift in all subjects as well.

      The air-Q and air-Q SP are commercially-available supraglottic airways (SGAs) that can be
      used for primary airway maintenance or as a conduit for FOI, as can be the Williams,
      Ovassapian, and Berman Intubating Airways. The air-Q products have the same overall
      geometrical design, but differ in their cuff inflating mechanisms, where the air-Q uses a
      traditional pilot balloon valve, while the air-Q SP utilizes a self-inflating cuff that
      dynamically adjusts according to the relative resistances to airflow between the patient's
      lungs and the device's cuff. In prior trials comparing the air-Q and air-Q SP with the two
      other commercially-available SGAs, the air-Q and air-Q SP bowl design provided a partial or
      full view of the vocal cords in 80-92% of subjects without requiring any additional airway
      maneuvers applied by an assistant (e.g., jaw thrust, anterior jaw lift, or lingual
      retraction) (Galgon, 2011; Galgon, 2015). Presumably, in these situations, successful
      tracheal intubation using the air-Q or air-Q SP could have been achieved by a single operator
      versus requiring one or more assistants. However, this potential performance advantage has
      not yet been tested. Therefore, the purpose of this study is to compare use of the air-Q SP
      against the WA for FBI performed by a single operator.

      The air-Q SP, rather than the air-Q, is chosen for this study because its lack of a pilot
      balloon valve allows its stem to be easily shortened to ease device removal over the
      coaxially placed tracheal tube. The WA is chosen for this study because it has performed best
      in past trials and is the airway routinely used by the study principal investigator (PI) for
      FBI. Both devices are commercially-available and being used in the study in accordance with
      their labeled intended use.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Adult patients presenting for a surgical or interventional procedure requiring general anesthesia and tracheal intubation, who do not meet any of the study exclusion criteria, and who give their informed consent, will be randomly allocated to receive either an air-Q SP or Williams Intubating Airway as a conduit to aid flexible bronchoscopic intubation.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Each study subject will be blinded to the study device they receive; however, the anesthesia provider will not be blinded to the study device and will have access to all monitors deemed appropriate by the primary anesthesia team caring for the subject.
measure: The primary endpoint is single-operator intubation success.
time frame: 15 minutes
description: The primary purpose of this study is to compare the single-operator intubation success using the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation.
measure: Time required for conduit placement
time frame: 15 minutes
description: The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
measure: Time required for each intubation attempt
time frame: 15 minutes
description: The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
measure: Overall intubation time
time frame: 15 minutes
description: The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
measure: Number of attempts required for conduit placement
time frame: 15 minutes
description: The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
measure: Number of attempts for successful intubation
time frame: 15 minutes
description: The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
measure: Number and types of assistive airway maneuvers (e.g., jaw thrust, lingual retraction, etc.) for successful intubation
time frame: 15 minutes
description: The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
measure: Successful intubation method
time frame: 15 minutes
description: The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
measure: Tracheal tube dislodgment rate during conduit removal
time frame: 15 minutes
description: The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
measure: Oxygen desaturation rate
time frame: 15 minutes
description: The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
measure: Post operative sore throat rate.
time frame: 4 hours
description: The secondary purposes of this study are to compare device performance characteristics and patient responses to use of the air-Q SP versus the Williams Intubating Airway as a conduit for flexible bronchoscopic intubation
arm group label: Air-Q SP
arm group type: Experimental
description: air-Q Self-Pressurizing intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mecury Medical, Clearwater, FL, USA)
arm group label: Williams Intubating Airway
arm group type: Experimental
description: Airway Intubator, Williams, Adult Female, Single Use, Molded Surlyn Plastic, 9 cm or Airway Intubator, Williams, Adult Male, Single Use, Molded Surlyn Plastic, 10 cm
intervention type: Device
intervention name: air-Q® SP
description: air-Q SP placement for airway maintenance,
arm group label: Air-Q SP
other name: air-Q SP placement for airway maintenance
intervention type: Device
intervention name: Williams Airway Intubator (WA)
description: WA is placed in subject's oropharynx. If the vocal cords are not in view at the end of the WA, the operator may ask an assistant to perform an airway maneuver (e.g., jaw thrust, anterior jaw lift, or lingual traction) to attempt to bring the vocal cords into view
arm group label: Williams Intubating Airway
other name: WA is placed in subject's oropharynx.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Richard E Galgon, MD, MS
role: Principal Investigator
affiliation: Department of Anesthesiology,University of Wisconsin, Madison, Wisconsin, United States, 53792
facility: 
country: United States
url: https://www.ncbi.nlm.nih.gov/pubmed/21880031?dopt=Abstract
description: Galgon RE, Schroeder KM, Han S, et al. The air-Q(®) intubating laryngeal airway vs the LMA-ProSeal(TM) : a prospective, randomised trial of airway seal pressure. Anaesthesia. 2011 Dec;66(12):1093-100.
citation: Galgon RE, Schroeder KM, Han S, Andrei A, Joffe AM. The air-Q((R)) intubating laryngeal airway vs the LMA-ProSeal(TM) : a prospective, randomised trial of airway seal pressure. Anaesthesia. 2011 Dec;66(12):1093-100. doi: 10.1111/j.1365-2044.2011.06863.x. Epub 2011 Aug 22.
PMID: 21880031
responsible party type: Sponsor
sharing ipd: No
ipd description: There is no plan to make individual participant data available to other researchers.