<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/NCT01720017</url>
  </required_header>
  <id_info>
    <org_study_id>2012-0636</org_study_id>
    <nct_id>NCT01720017</nct_id>
  </id_info>
  <brief_title>Impact of Manikin Training on Airtraq Avant Learning Curve in Predicted Difficult Airways</brief_title>
  <official_title>The Impact of Airway Manikin Training on the Airtraq Avant and Wireless Monitor System Learning Curve in Airways With Predictors for Difficult 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall purpose of this study is to assess the impact of preclinical airway manikin&#xD;
      training using the Airtraq Avant and Wireless Monitor System under simulated difficult airway&#xD;
      conditions (c-collar and swollen tongue) on the clinical learning curve of using the&#xD;
      device/system in airways with predictors for difficult intubation.&#xD;
&#xD;
      The investigators hypothesize that the clinical learning curve in airways with predictors for&#xD;
      difficult intubation will be shorter for study subjects (operators) who undergo preclinical&#xD;
      manikin training under simulated difficult airway conditions compared to Study subjects&#xD;
      (operators) who do not receive this training. The clinical learning curve is characterized by&#xD;
      procedure times and first attempt success rates on successive uses of the Airtraq Avant and&#xD;
      Wireless Monitor System in patients with at least one predictor for difficult intubation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Tracheal intubation (placement of a breathing tube below the vocal cords into the trachea) is&#xD;
      an essential skill for the anesthesia provider. Training on the use of new technology (i.e.,&#xD;
      procedural training), including video/optical laryngoscopy (e.g., the Airtraq Avant,&#xD;
      Glidescope, and similar devices) usually occurs under the tutelage of learned practitioners,&#xD;
      while caring for actual patients in the operating room, not during didactic sessions in a&#xD;
      classroom. Although the use of airway trainers (manikins) has led to improved clinical&#xD;
      learning curves for the use of some airway devices, it is not known if training on the use of&#xD;
      the Airtraq Avant and Wireless Monitor System under simulated difficult airway conditions&#xD;
      (c-collar and swollen tongue) will improve the learning curve of using the device/system&#xD;
      clinically in in patients with at least one predictor of difficult intubation.&#xD;
&#xD;
      The specific aim of this study is to compare the clinical learning curve, characterized by&#xD;
      procedure times and first attempt success rates on successive uses, of using the Airtraq&#xD;
      Avant and Wireless Monitor System in patients with at least one predictor for diffcult&#xD;
      intubation between anesthesia providers who receive preclinical airway manikin training under&#xD;
      simulated difficult airway conditions (c-collar and swollen tongue) and those who do not. The&#xD;
      subjects of this study are anesthesia providers enrolled in the study.&#xD;
&#xD;
      Secondary specific aims include assessing the impact of preclinical airway manikin training&#xD;
      under simulated difficult airway conditions on glottic view grade, glottic view attainment&#xD;
      maneuvers, ease of Airtraq Avant insertion, ease of tracheal tube insertion, mechanisms of&#xD;
      tracheal tube insertion impediment, and perceived overall clinical usefulness in airways with&#xD;
      predictors of difficult intubation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulty was encountered with the subjects completing their required 20 intubations in&#xD;
    patients with at least one predictor of difficult intubation.&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intubation time</measure>
    <time_frame>Within the first 3 minutes of 20 successive intubations.</time_frame>
    <description>Repeated measure of intubation efficiency using the Airtraq Avant and Wireless Monitor System in airways with at least one predictor of difficult intubation, defined as the time from placing the videolaryngoscope into the patient's mouth to passage of the tracheal tube balloon below the vocal cords.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>First attempt success rate</measure>
    <time_frame>Within the first 3 minutes of 20 successive intubations.</time_frame>
    <description>Cumulative measure of intubation success on first attempt over 20 successive uses of the Airtraq Avant and Wireless Monitor System in airways with at least one predictor of difficult intubation, defined as the ability to place a tracheal tube below a patient's vocal cords on the first attempt without removing the videolaryngoscope from the patient's mouth.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Glottic view grade</measure>
    <time_frame>Within the first 3 minutes of 20 successive intubations</time_frame>
    <description>Determined as the best view obtained when attempting to use the Airtraq Avant and Wireless Monitor System to pass a tracheal tube below a patient's vocal cords. Grade 1 = full view of vocal cords. Grade 2a = partial view of vocal cords. Grade 2b = no vocal cords seen. Arytenoids visible. Grade 3 = No view of the vocal cords or arytenoids. Anterior epiglottis visible. Grade 4 = Only soft tissue visible. No view of the periglottic structures, including the epiglottis, is present.</description>
  </other_outcome>
  <other_outcome>
    <measure>Ease of Airtraq Avant insertion Avant insertion</measure>
    <time_frame>Within the first 3 minutes of 20 successive intubations</time_frame>
    <description>Graded by the study subject on a 6-point Lickert scale (1 = easy, no difficulty; 6 = difficult, nearly impossible) when attempting to insert the Airtraq Avant into a patient's mouth.</description>
  </other_outcome>
  <other_outcome>
    <measure>Ease of tracheal intubation</measure>
    <time_frame>Within the first 3 minutes of 20 successive intubations</time_frame>
    <description>Graded by the study subject on a 6-point Lickert scale (1 = easy, no difficulty; 6 = difficult, nearly impossible) when attempting to pass a tracheal tube below a patient's vocal cords using the Airtraq Avant and Wireless Monitor System.</description>
  </other_outcome>
  <other_outcome>
    <measure>Mechanisms of tracheal tube insertion impediment</measure>
    <time_frame>Within the first 3 minutes of 20 successive intubations</time_frame>
    <description>Observational description of features causing impediments to tracheal tube insertion (e.g., tube hitting the epiglottis or tube hitting the arytenoid). Recorded by the study subject at the time of attempt at placing a tracheal tube below a patient's vocal cords using the Aitraq Avant and Wireless Monitor System.</description>
  </other_outcome>
  <other_outcome>
    <measure>Overall clinical usefulness</measure>
    <time_frame>Within the first 3 minutes of 20 successive intubations</time_frame>
    <description>Recorded as excellent, good, fair, or inadequate by the study subject when using the Airtraq Avant and Wireless Monitor System to place a tracheal tube below a patient's vocal cords.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Education</condition>
  <condition>Training</condition>
  <condition>Manikin</condition>
  <arm_group>
    <arm_group_label>Inservice Training Only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Inservice training will include review of a product information handout and a video demonstration. Specific attention will be given to (1) describing each system component and its operation, (2) attaching the wireless camera head and coordinating channel selection with the monitor, (3) turning on the Airtraq Avant light and device preparation for use, (4) Airtraq Avant insertion into the patient's mouth and advancement into the hypopharynx (deep in the throat) to obtain a view of the vocal cords, (5) use of standard lift and rotation movements to optimize the vocal cord view, (6) tracheal tube advancement through the vocal cords tracheal intubation, (7) standard methods for confirmation of correct tracheal tube placement, (8) tracheal tube removal from the Airtraq Avant and the Airtraq Avant removal from the patient's mouth, and (9) disposal of the disposable blade and cleaning of the reusable optics insert.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Inservice and Manikin Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study subjects in this group will receive the standard inservice training described above, as well as, preclinical manikin training on use of the Airtraq Avant and Wireless Monitor System in simulated difficult airway conditions (swollen tongue and cervical collar). During the preclinical manikin training, each subject will perform 10 intubations. Performance characteristics including attempts for successful Airtraq Avant insertion, glottic view obtained, ease of insertion, ease of tracheal intubation, time required for tracheal intubation, and attempts for successful tracheal intubation will be recorded for each intubation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Preclinical Manikin Training</intervention_name>
    <description>During the preclinical manikin training, each subject will perform 10 intubations in a manikin with a difficult airway simulated by swelling the manikin tongue and placing it in a cervical collar.</description>
    <arm_group_label>Inservice and Manikin Training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Inservice Training</intervention_name>
    <description>Inservice training will include review of a product information handout and a video demonstration.</description>
    <arm_group_label>Inservice Training Only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  anesthesia providers (i.e., anesthesia residents, anesthetists, and staff&#xD;
             anesthesiologists)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 years of age&#xD;
&#xD;
          -  non-english speaking&#xD;
&#xD;
          -  unwilling to sign a study consent form&#xD;
&#xD;
          -  related financially or otherwise to the Airtraq Avant manufacturer will not be&#xD;
             eligible.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard E Galgon, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Wisconsin Hospital 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>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>September 30, 2015</last_update_submitted>
  <last_update_submitted_qc>September 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Airtraq</keyword>
  <keyword>laryngoscope</keyword>
  <keyword>airway</keyword>
  <keyword>difficult</keyword>
  <keyword>training</keyword>
  <keyword>manikin</keyword>
  <!-- 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/NCT01720017
org study id: 2012-0636
nct id: NCT01720017
lead sponsor: 
has dmc: No
The overall purpose of this study is to assess the impact of preclinical airway manikin
      training using the Airtraq Avant and Wireless Monitor System under simulated difficult airway
      conditions (c-collar and swollen tongue) on the clinical learning curve of using the
      device/system in airways with predictors for difficult intubation.

      The investigators hypothesize that the clinical learning curve in airways with predictors for
      difficult intubation will be shorter for study subjects (operators) who undergo preclinical
      manikin training under simulated difficult airway conditions compared to Study subjects
      (operators) who do not receive this training. The clinical learning curve is characterized by
      procedure times and first attempt success rates on successive uses of the Airtraq Avant and
      Wireless Monitor System in patients with at least one predictor for difficult intubation.
Tracheal intubation (placement of a breathing tube below the vocal cords into the trachea) is
      an essential skill for the anesthesia provider. Training on the use of new technology (i.e.,
      procedural training), including video/optical laryngoscopy (e.g., the Airtraq Avant,
      Glidescope, and similar devices) usually occurs under the tutelage of learned practitioners,
      while caring for actual patients in the operating room, not during didactic sessions in a
      classroom. Although the use of airway trainers (manikins) has led to improved clinical
      learning curves for the use of some airway devices, it is not known if training on the use of
      the Airtraq Avant and Wireless Monitor System under simulated difficult airway conditions
      (c-collar and swollen tongue) will improve the learning curve of using the device/system
      clinically in in patients with at least one predictor of difficult intubation.

      The specific aim of this study is to compare the clinical learning curve, characterized by
      procedure times and first attempt success rates on successive uses, of using the Airtraq
      Avant and Wireless Monitor System in patients with at least one predictor for diffcult
      intubation between anesthesia providers who receive preclinical airway manikin training under
      simulated difficult airway conditions (c-collar and swollen tongue) and those who do not. The
      subjects of this study are anesthesia providers enrolled in the study.

      Secondary specific aims include assessing the impact of preclinical airway manikin training
      under simulated difficult airway conditions on glottic view grade, glottic view attainment
      maneuvers, ease of Airtraq Avant insertion, ease of tracheal tube insertion, mechanisms of
      tracheal tube insertion impediment, and perceived overall clinical usefulness in airways with
      predictors of difficult intubation.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Outcomes Assessor)
measure: Intubation time
time frame: Within the first 3 minutes of 20 successive intubations.
description: Repeated measure of intubation efficiency using the Airtraq Avant and Wireless Monitor System in airways with at least one predictor of difficult intubation, defined as the time from placing the videolaryngoscope into the patient's mouth to passage of the tracheal tube balloon below the vocal cords.
measure: First attempt success rate
time frame: Within the first 3 minutes of 20 successive intubations.
description: Cumulative measure of intubation success on first attempt over 20 successive uses of the Airtraq Avant and Wireless Monitor System in airways with at least one predictor of difficult intubation, defined as the ability to place a tracheal tube below a patient's vocal cords on the first attempt without removing the videolaryngoscope from the patient's mouth.
measure: Glottic view grade
time frame: Within the first 3 minutes of 20 successive intubations
description: Determined as the best view obtained when attempting to use the Airtraq Avant and Wireless Monitor System to pass a tracheal tube below a patient's vocal cords. Grade 1 = full view of vocal cords. Grade 2a = partial view of vocal cords. Grade 2b = no vocal cords seen. Arytenoids visible. Grade 3 = No view of the vocal cords or arytenoids. Anterior epiglottis visible. Grade 4 = Only soft tissue visible. No view of the periglottic structures, including the epiglottis, is present.
measure: Ease of Airtraq Avant insertion Avant insertion
time frame: Within the first 3 minutes of 20 successive intubations
description: Graded by the study subject on a 6-point Lickert scale (1 = easy, no difficulty; 6 = difficult, nearly impossible) when attempting to insert the Airtraq Avant into a patient's mouth.
measure: Ease of tracheal intubation
time frame: Within the first 3 minutes of 20 successive intubations
description: Graded by the study subject on a 6-point Lickert scale (1 = easy, no difficulty; 6 = difficult, nearly impossible) when attempting to pass a tracheal tube below a patient's vocal cords using the Airtraq Avant and Wireless Monitor System.
measure: Mechanisms of tracheal tube insertion impediment
time frame: Within the first 3 minutes of 20 successive intubations
description: Observational description of features causing impediments to tracheal tube insertion (e.g., tube hitting the epiglottis or tube hitting the arytenoid). Recorded by the study subject at the time of attempt at placing a tracheal tube below a patient's vocal cords using the Aitraq Avant and Wireless Monitor System.
measure: Overall clinical usefulness
time frame: Within the first 3 minutes of 20 successive intubations
description: Recorded as excellent, good, fair, or inadequate by the study subject when using the Airtraq Avant and Wireless Monitor System to place a tracheal tube below a patient's vocal cords.
arm group label: Inservice Training Only
arm group type: Active Comparator
description: Inservice training will include review of a product information handout and a video demonstration. Specific attention will be given to (1) describing each system component and its operation, (2) attaching the wireless camera head and coordinating channel selection with the monitor, (3) turning on the Airtraq Avant light and device preparation for use, (4) Airtraq Avant insertion into the patient's mouth and advancement into the hypopharynx (deep in the throat) to obtain a view of the vocal cords, (5) use of standard lift and rotation movements to optimize the vocal cord view, (6) tracheal tube advancement through the vocal cords tracheal intubation, (7) standard methods for confirmation of correct tracheal tube placement, (8) tracheal tube removal from the Airtraq Avant and the Airtraq Avant removal from the patient's mouth, and (9) disposal of the disposable blade and cleaning of the reusable optics insert.
arm group label: Inservice and Manikin Training
arm group type: Experimental
description: Study subjects in this group will receive the standard inservice training described above, as well as, preclinical manikin training on use of the Airtraq Avant and Wireless Monitor System in simulated difficult airway conditions (swollen tongue and cervical collar). During the preclinical manikin training, each subject will perform 10 intubations. Performance characteristics including attempts for successful Airtraq Avant insertion, glottic view obtained, ease of insertion, ease of tracheal intubation, time required for tracheal intubation, and attempts for successful tracheal intubation will be recorded for each intubation.
intervention type: Other
intervention name: Preclinical Manikin Training
description: During the preclinical manikin training, each subject will perform 10 intubations in a manikin with a difficult airway simulated by swelling the manikin tongue and placing it in a cervical collar.
arm group label: Inservice and Manikin Training
intervention type: Other
intervention name: Inservice Training
description: Inservice training will include review of a product information handout and a video demonstration.
arm group label: Inservice Training Only
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Richard E Galgon, MD, MS
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
responsible party type: Sponsor