<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/NCT03230422</url>
  </required_header>
  <id_info>
    <org_study_id>Johannes GU</org_study_id>
    <nct_id>NCT03230422</nct_id>
  </id_info>
  <brief_title>A Comparison of Video Laryngoscopes and the Direct Laryngoscope in Simulated Normal and Difficult Infant Airway.</brief_title>
  <acronym>Kivi</acronym>
  <official_title>A Comparison of the Novel King Vision Pediatric aBlade and the C-MAC Video Laryngoscope to the Direct Laryngoscope in Simulated Normal and Difficult Infant Airway. A Bicentric, Prospective, Randomized Manikin Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johannes Gutenberg University Mainz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johannes Gutenberg University Mainz</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>
      In Pediatric both manikin and human studies have suggested that the video laryngoscopy is&#xD;
      equally suitable to facilitate intubation compared to the direct laryngoscopy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The King Vision Pediatric aBlade is a novel video laryngoscopy for securing the airway of new&#xD;
      born and infants. In this manikin studie we want to compare different types of video&#xD;
      laryngoscopes in a simulated normal and difficult infant airway.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 24, 2017</start_date>
  <completion_date type="Actual">September 27, 2017</completion_date>
  <primary_completion_date type="Actual">July 31, 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>residents, fellows and attending with different level of experience</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Time to ventilation (seconds)</measure>
    <time_frame>Assessed intraoperatively at time of intubation (seconds)</time_frame>
    <description>Three timepoints will be recorded, beginning with the insertion of the device past the theeth/gum into the mouth. These will inlcude time to best view, time to removal of device from the mouth, and the time to the first chest raising of the simulator</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>First attempt success rate of tracheal intubation (in 40 seconds)</measure>
    <time_frame>Assessed intraoperatively at time of intubation</time_frame>
    <description>An attempt at tracheal intubation will be defined as entry of the device into the patient's mouth without the need to remove the device once entered and securing the airway.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grades of Laryngeal View (Cormack&amp;Lehane Class)</measure>
    <time_frame>Assessed intraoperatively at time of intubation</time_frame>
    <description>Cormack&amp;Lehane Grade (1-4) and percentage of glottic opening (POGO) (%) will be recorded after insertion of the laryngoscope</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of ELM</measure>
    <time_frame>Assessed intraoperatively at time of intubation</time_frame>
    <description>BURP or change the head/Shoulder position to optimised the glottic view will be recorded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intubation Adjustments &amp; Ease of Use</measure>
    <time_frame>Assessed intraoperatively following intubation</time_frame>
    <description>Airway manipulations utilized and ease of use (Likert 1-5) will be assessed by the user following the intubation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Airway Complication of Anesthesia</condition>
  <arm_group>
    <arm_group_label>normal airway</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Time (normal airway) using the novel King Vision™ Pediatric aBlade (KV) video laryngoscope, C-MAC™ D-blade Ped (DP), C-MAC™ Miller Blade (MB), shortened as VL, compared with conventional direct laryngoscopy (DL)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>difficult airway</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Time (difficult airway) using the novel King Vision™ Pediatric aBlade (KV) video laryngoscope, C-MAC™ D-blade Ped (DP), C-MAC™ Miller Blade (MB), shortened as VL, compared with conventional direct laryngoscopy (DL)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>normal airway</intervention_name>
    <description>The Time interval between the laryngoscope blade passing the teeth/gums to the announcing of the first ventilation was recorded as the time to ventilation with the Video laryngoscopy (VL) or conventional direct laryngoscopy (DL)</description>
    <arm_group_label>difficult airway</arm_group_label>
    <arm_group_label>normal airway</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>difficult airway</intervention_name>
    <description>The Time interval between the laryngoscope blade passing the teeth/gums to the announcing of the first ventilation was recorded as the time to ventilation with the Video laryngoscopy (VL) or conventional direct laryngoscopy (DL)</description>
    <arm_group_label>difficult airway</arm_group_label>
    <arm_group_label>normal airway</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - anesthesiologists or neonatal/pediatric intensive care medicice specialists with&#xD;
        experience in securing pediatric airway&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - participants without experience in pediatric airway management&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marc Kriege, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Centre Mainz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University</name>
      <address>
        <city>Mainz</city>
        <state>Rhineland-Palatinate</state>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <results_reference>
    <citation>Jagannathan N, Hajduk J, Sohn L, Huang A, Sawardekar A, Albers B, Bienia S, De Oliveira GS. Randomized equivalence trial of the King Vision aBlade videolaryngoscope with the Miller direct laryngoscope for routine tracheal intubation in children &lt;2 yr of age. Br J Anaesth. 2017 Jun 1;118(6):932-937. doi: 10.1093/bja/aex073.</citation>
    <PMID>28549081</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>July 23, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>September 28, 2017</last_update_submitted>
  <last_update_submitted_qc>September 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johannes Gutenberg University Mainz</investigator_affiliation>
    <investigator_full_name>Marc Kriege, MD</investigator_full_name>
    <investigator_title>Dr. med. Marc Kriege, Dr. med. Nina Pirlich</investigator_title>
  </responsible_party>
  <keyword>infant, laryngoscopes, pediatrics</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03230422
org study id: Johannes GU
nct id: NCT03230422
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In Pediatric both manikin and human studies have suggested that the video laryngoscopy is
      equally suitable to facilitate intubation compared to the direct laryngoscopy.
The King Vision Pediatric aBlade is a novel video laryngoscopy for securing the airway of new
      born and infants. In this manikin studie we want to compare different types of video
      laryngoscopes in a simulated normal and difficult infant airway.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
masking description: residents, fellows and attending with different level of experience
measure: Time to ventilation (seconds)
time frame: Assessed intraoperatively at time of intubation (seconds)
description: Three timepoints will be recorded, beginning with the insertion of the device past the theeth/gum into the mouth. These will inlcude time to best view, time to removal of device from the mouth, and the time to the first chest raising of the simulator
measure: First attempt success rate of tracheal intubation (in 40 seconds)
time frame: Assessed intraoperatively at time of intubation
description: An attempt at tracheal intubation will be defined as entry of the device into the patient's mouth without the need to remove the device once entered and securing the airway.
measure: Grades of Laryngeal View (Cormack&Lehane Class)
time frame: Assessed intraoperatively at time of intubation
description: Cormack&Lehane Grade (1-4) and percentage of glottic opening (POGO) (%) will be recorded after insertion of the laryngoscope
measure: Use of ELM
time frame: Assessed intraoperatively at time of intubation
description: BURP or change the head/Shoulder position to optimised the glottic view will be recorded
measure: Intubation Adjustments & Ease of Use
time frame: Assessed intraoperatively following intubation
description: Airway manipulations utilized and ease of use (Likert 1-5) will be assessed by the user following the intubation.
arm group label: normal airway
arm group type: Experimental
description: Time (normal airway) using the novel King Vision™ Pediatric aBlade (KV) video laryngoscope, C-MAC™ D-blade Ped (DP), C-MAC™ Miller Blade (MB), shortened as VL, compared with conventional direct laryngoscopy (DL)
arm group label: difficult airway
arm group type: Experimental
description: Time (difficult airway) using the novel King Vision™ Pediatric aBlade (KV) video laryngoscope, C-MAC™ D-blade Ped (DP), C-MAC™ Miller Blade (MB), shortened as VL, compared with conventional direct laryngoscopy (DL)
intervention type: Device
intervention name: normal airway
description: The Time interval between the laryngoscope blade passing the teeth/gums to the announcing of the first ventilation was recorded as the time to ventilation with the Video laryngoscopy (VL) or conventional direct laryngoscopy (DL)
arm group label: difficult airway
arm group label: normal airway
intervention type: Device
intervention name: difficult airway
description: The Time interval between the laryngoscope blade passing the teeth/gums to the announcing of the first ventilation was recorded as the time to ventilation with the Video laryngoscopy (VL) or conventional direct laryngoscopy (DL)
arm group label: difficult airway
arm group label: normal airway
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Marc Kriege, MD
role: Principal Investigator
affiliation: University Medical Centre Mainz
facility: 
country: Germany
citation: Jagannathan N, Hajduk J, Sohn L, Huang A, Sawardekar A, Albers B, Bienia S, De Oliveira GS. Randomized equivalence trial of the King Vision aBlade videolaryngoscope with the Miller direct laryngoscope for routine tracheal intubation in children <2 yr of age. Br J Anaesth. 2017 Jun 1;118(6):932-937. doi: 10.1093/bja/aex073.
PMID: 28549081
responsible party type: Principal Investigator
investigator affiliation: Johannes Gutenberg University Mainz
investigator full name: Marc Kriege, MD
investigator title: Dr. med. Marc Kriege, Dr. med. Nina Pirlich
sharing ipd: No