<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/NCT02198742</url>
  </required_header>
  <id_info>
    <org_study_id>H28224</org_study_id>
    <nct_id>NCT02198742</nct_id>
  </id_info>
  <brief_title>A Comparison Between Two Video Laryngoscopes,in Successfully Intubating Pediatric Mannequins w/wo Difficult Airways</brief_title>
  <official_title>A Comparison Between Two Video Laryngoscopes,the Truview PCD and the Glidescope Cobalt AVL, in Successfully Intubating Pediatric Mannequins With and Without Difficult Airways</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baylor College of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a randomized crossover study where anesthesia practitioners will intubate three&#xD;
      different pediatric infant mannequins (normal airway, anterior larynx, Pierre Robin syndrome&#xD;
      anatomy) using three different intubation devices (the Miller blade, the Truview VL, the&#xD;
      Glidescope Cobalt video-laryngoscope) in two different scenarios (normal neck and with an&#xD;
      immobile neck). The order of presentation will be randomized. As this is a cross over study,&#xD;
      all subjects will complete all scenarios. There is no placebo group, and each subject wil be&#xD;
      his or her own control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants will be given individual, standardized instructions and demonstrations for each&#xD;
      device as per the manufacturers' instructions. The participants will practice with&#xD;
      instructor's feedback on an infant mannequin with a normal airway until he/she feel&#xD;
      comfortable with each of the three devices. The investigator will record the prior experience&#xD;
      of the participant in using each of the 3 devices in clinical situations. Each subject will&#xD;
      be asked to intubate each of the mannequins with each of the devices. The choice of the order&#xD;
      of device and mannequin will be based on a Latin square design and the sequence will be&#xD;
      assigned to participants based on a computer generated random number. A closed envelope&#xD;
      technique will blind participants and investigators to the order of airway device and&#xD;
      mannequin till the start of the individual trial. Participants will first finish the test on&#xD;
      unchanged conditions and then repeat the process using the same order of mannequins and&#xD;
      devices but with the neck held immobile to simulate a scenario of a child with an unstable&#xD;
      cervical spine. Data from different scenarios will be recorded from a total number of 18&#xD;
      attempts of tracheal intubation per participant. Participants will be asked to proceed as&#xD;
      though they were in the operating room with an assistant available to follow their commands.&#xD;
      The order of presentation of each mannequin, airway device and scenario will be randomized as&#xD;
      described above. The time from placing the device in the mannequin's mouth to the time the&#xD;
      Ambu bag is connected to the end of the tracheal tube and a positive pressure breath is given&#xD;
      will constitute the intubation time. During each intubation the participant will be asked to&#xD;
      state when he or she has obtained the best view for intubation and this time this will be&#xD;
      recorded as the time for visualization. The subject will assess the quality of the best&#xD;
      glottic view on the Cormack - Lehane grade of 1 -4. The investigators will record all&#xD;
      maneuvers to optimize visualization of the larynx such as tracheal pressure, lip retraction,&#xD;
      pulling the tongue forward etc. The time from entry of the device in the mouth to the time&#xD;
      the tracheal tube is started to be advanced is the visualization time. The time a positive&#xD;
      pressure breath is given at the end of the tracheal tube will constitute the end of the&#xD;
      attempt of intubation. A failed attempt is defined as removal of the laryngoscope from the&#xD;
      mouth without a successful intubation. The number of times the endotracheal tube is advanced&#xD;
      will also be recorded. Failure of intubation will be defined as unrecognized esophageal&#xD;
      intubation, abandoned procedure, intubation taking longer than 120 seconds and intubation&#xD;
      requiring more than 3 attempts. The observer will estimate the maximum force applied to the&#xD;
      maxilla on a 0 -10 scale where 0= no force and 10 = maximum force with distortion of the&#xD;
      maxilla. The observer will also estimate potential damage of laryngeal structures on a 0 -10&#xD;
      scale.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time required for successful endotracheal intubation with the three devices.</measure>
    <time_frame>Subjects complete study in 1 day</time_frame>
    <description>The devices to be compared include (1)the standard Miller blade, (2) the GlideScope Cobalt AVL and (3) the Truview PCD video-laryngoscopes. Successful intubation will be measured in the seconds from the time the recorder says &quot;begin&quot; until time of first positive pressure breath and confirmation endotracheal tube is in the trachea.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to visualize the larynx</measure>
    <time_frame>From time recorder says &quot;begin&quot; till subject rates best view up to 3minutes</time_frame>
    <description>Start time is when the recorder says &quot;begin&quot; . The time to visualize the larynx ends when the subject rates best view of the larynx.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time from visualization of larynx to tracheal intubation</measure>
    <time_frame>one day</time_frame>
    <description>time from the beginning of the endotracheal tube being inserted till first positive pressure breath measured in seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of attempts at tracheal intubation</measure>
    <time_frame>one day</time_frame>
    <description>Subjects were allowed a total of 3 attempts at tracheal intubation with a device on a mannequin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of failed attempts</measure>
    <time_frame>one day</time_frame>
    <description>Subjects were allowed 3 unsuccessful attempts with each device. After 3 unsuccessful attempts with a device the subject was considered to have failed that device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of force on the maxilla</measure>
    <time_frame>one day</time_frame>
    <description>Observer rated the amount of force on the maxilla based on a 0-10 point scale. The observer was the same for all cases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optimization measures for laryngeal visualization and tracheal intubation</measure>
    <time_frame>one day</time_frame>
    <description>The subjects were allowed to ask for assistance with optimization such as external tracheal pressure, lip retraction, or pulling on the tongue. All subjects were instructed that no measures would be taken unless asked for and intructed on what assistance was needed. The observer recorded and counted all optimizing measures.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Documentation of participant's comments on preference of device</measure>
    <time_frame>one day</time_frame>
    <description>All participants were asked at the completion of the study what device they prefered for a case with anticipated difficult intubation. A count was made of their preference.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Intubation; Difficult</condition>
  <arm_group>
    <arm_group_label>Miller blade</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects must have &gt;500 intubations in order to participate in this study. There is no placebo group, and each subject wil be his or her own control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Truview PCD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects were given a quick guide of the Truview PCD supplied by the manufacturer with step by step instructions for use. They were also given time to practice with the device on a normal model until they felt comfortable. There is no placebo group, and each subject wil be his or her own control.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glidescope Cobolt</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects were required to watch a instructional video provided by the manufacterer. Subjects were then allowed to practice on a normal model until they felt comfortable before beginning the study. There is no placebo group, and each subject wil be his or her own control.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Miller blade</intervention_name>
    <description>To participate in the study the subjects must have &gt;500 intubations with the miller blade.</description>
    <arm_group_label>Miller blade</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Truview PCD</intervention_name>
    <description>Subjects were given a quick guide of the Truview PCD supplied by the manufacturer with step by step instructions for use. They were also given time to practice with the device on a normal model until they felt comfortable.</description>
    <arm_group_label>Truview PCD</arm_group_label>
    <other_name>Trueview PCD - Multichoice video laryngoscope system</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Glidescope Cobolt</intervention_name>
    <description>Subjects were required to watch a instructional video provided by the manufacturer. Subjects were then allowed to practice on a normal model until they felt comfortable before beginning the study. There is no placebo group, and each subject wil be his or her own control.</description>
    <arm_group_label>Glidescope Cobolt</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Anesthesia practitioners including anesthesia attendings, fellows, residents CAIII and&#xD;
             CRNA's at Texas Children's Hospital Department of Anesthesiology with clinical&#xD;
             experience of &gt;500 intubations with Miller blades.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anesthesia practitioners with &lt;500 intubations with Miller blades.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helena Karlberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Texas Children't Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>January 15, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>February 2, 2015</last_update_submitted>
  <last_update_submitted_qc>February 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Helena Karlberg</investigator_full_name>
    <investigator_title>Pediatric Anesthesiologist</investigator_title>
  </responsible_party>
  <!-- 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/NCT02198742
org study id: H28224
nct id: NCT02198742
lead sponsor: 
has dmc: No
The study is a randomized crossover study where anesthesia practitioners will intubate three
      different pediatric infant mannequins (normal airway, anterior larynx, Pierre Robin syndrome
      anatomy) using three different intubation devices (the Miller blade, the Truview VL, the
      Glidescope Cobalt video-laryngoscope) in two different scenarios (normal neck and with an
      immobile neck). The order of presentation will be randomized. As this is a cross over study,
      all subjects will complete all scenarios. There is no placebo group, and each subject wil be
      his or her own control.
Participants will be given individual, standardized instructions and demonstrations for each
      device as per the manufacturers' instructions. The participants will practice with
      instructor's feedback on an infant mannequin with a normal airway until he/she feel
      comfortable with each of the three devices. The investigator will record the prior experience
      of the participant in using each of the 3 devices in clinical situations. Each subject will
      be asked to intubate each of the mannequins with each of the devices. The choice of the order
      of device and mannequin will be based on a Latin square design and the sequence will be
      assigned to participants based on a computer generated random number. A closed envelope
      technique will blind participants and investigators to the order of airway device and
      mannequin till the start of the individual trial. Participants will first finish the test on
      unchanged conditions and then repeat the process using the same order of mannequins and
      devices but with the neck held immobile to simulate a scenario of a child with an unstable
      cervical spine. Data from different scenarios will be recorded from a total number of 18
      attempts of tracheal intubation per participant. Participants will be asked to proceed as
      though they were in the operating room with an assistant available to follow their commands.
      The order of presentation of each mannequin, airway device and scenario will be randomized as
      described above. The time from placing the device in the mannequin's mouth to the time the
      Ambu bag is connected to the end of the tracheal tube and a positive pressure breath is given
      will constitute the intubation time. During each intubation the participant will be asked to
      state when he or she has obtained the best view for intubation and this time this will be
      recorded as the time for visualization. The subject will assess the quality of the best
      glottic view on the Cormack - Lehane grade of 1 -4. The investigators will record all
      maneuvers to optimize visualization of the larynx such as tracheal pressure, lip retraction,
      pulling the tongue forward etc. The time from entry of the device in the mouth to the time
      the tracheal tube is started to be advanced is the visualization time. The time a positive
      pressure breath is given at the end of the tracheal tube will constitute the end of the
      attempt of intubation. A failed attempt is defined as removal of the laryngoscope from the
      mouth without a successful intubation. The number of times the endotracheal tube is advanced
      will also be recorded. Failure of intubation will be defined as unrecognized esophageal
      intubation, abandoned procedure, intubation taking longer than 120 seconds and intubation
      requiring more than 3 attempts. The observer will estimate the maximum force applied to the
      maxilla on a 0 -10 scale where 0= no force and 10 = maximum force with distortion of the
      maxilla. The observer will also estimate potential damage of laryngeal structures on a 0 -10
      scale.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: Single (Participant)
measure: Time required for successful endotracheal intubation with the three devices.
time frame: Subjects complete study in 1 day
description: The devices to be compared include (1)the standard Miller blade, (2) the GlideScope Cobalt AVL and (3) the Truview PCD video-laryngoscopes. Successful intubation will be measured in the seconds from the time the recorder says "begin" until time of first positive pressure breath and confirmation endotracheal tube is in the trachea.
measure: Time to visualize the larynx
time frame: From time recorder says "begin" till subject rates best view up to 3minutes
description: Start time is when the recorder says "begin" . The time to visualize the larynx ends when the subject rates best view of the larynx.
measure: Time from visualization of larynx to tracheal intubation
time frame: one day
description: time from the beginning of the endotracheal tube being inserted till first positive pressure breath measured in seconds.
measure: Number of attempts at tracheal intubation
time frame: one day
description: Subjects were allowed a total of 3 attempts at tracheal intubation with a device on a mannequin.
measure: Number of failed attempts
time frame: one day
description: Subjects were allowed 3 unsuccessful attempts with each device. After 3 unsuccessful attempts with a device the subject was considered to have failed that device.
measure: Amount of force on the maxilla
time frame: one day
description: Observer rated the amount of force on the maxilla based on a 0-10 point scale. The observer was the same for all cases.
measure: Optimization measures for laryngeal visualization and tracheal intubation
time frame: one day
description: The subjects were allowed to ask for assistance with optimization such as external tracheal pressure, lip retraction, or pulling on the tongue. All subjects were instructed that no measures would be taken unless asked for and intructed on what assistance was needed. The observer recorded and counted all optimizing measures.
measure: Documentation of participant's comments on preference of device
time frame: one day
description: All participants were asked at the completion of the study what device they prefered for a case with anticipated difficult intubation. A count was made of their preference.
arm group label: Miller blade
arm group type: Active Comparator
description: Subjects must have >500 intubations in order to participate in this study. There is no placebo group, and each subject wil be his or her own control.
arm group label: Truview PCD
arm group type: Active Comparator
description: Subjects were given a quick guide of the Truview PCD supplied by the manufacturer with step by step instructions for use. They were also given time to practice with the device on a normal model until they felt comfortable. There is no placebo group, and each subject wil be his or her own control.
arm group label: Glidescope Cobolt
arm group type: Active Comparator
description: Subjects were required to watch a instructional video provided by the manufacterer. Subjects were then allowed to practice on a normal model until they felt comfortable before beginning the study. There is no placebo group, and each subject wil be his or her own control.
intervention type: Device
intervention name: Miller blade
description: To participate in the study the subjects must have >500 intubations with the miller blade.
arm group label: Miller blade
intervention type: Device
intervention name: Truview PCD
description: Subjects were given a quick guide of the Truview PCD supplied by the manufacturer with step by step instructions for use. They were also given time to practice with the device on a normal model until they felt comfortable.
arm group label: Truview PCD
other name: Trueview PCD - Multichoice video laryngoscope system
intervention type: Device
intervention name: Glidescope Cobolt
description: Subjects were required to watch a instructional video provided by the manufacturer. Subjects were then allowed to practice on a normal model until they felt comfortable before beginning the study. There is no placebo group, and each subject wil be his or her own control.
arm group label: Glidescope Cobolt
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Helena Karlberg, MD
role: Principal Investigator
affiliation: Baylor College of Medicine
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Helena Karlberg
investigator title: Pediatric Anesthesiologist