<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/NCT03271008</url>
  </required_header>
  <id_info>
    <org_study_id>6328</org_study_id>
    <nct_id>NCT03271008</nct_id>
  </id_info>
  <brief_title>Comparison of the Vividtrac™ and Other Videolaryngoscopes in Clinical Practice</brief_title>
  <official_title>Comparison of Necessary Time for Successful Intubation With the Vividtrac™ and KingVision™ Videolaryngoscopes and Macintosh Blade Direct Laryngoscopy in Clinical Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pecs</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pecs</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>
      Comparison of various videolaryngoscope devices (Vividtrac™ and KingVision™) and direct&#xD;
      laryngoscopy with Macintosh blade regarding laryngoscopy time, intubation time, intubation&#xD;
      success rate, percentage of visible glottic opening (POGO score) in elective and acute&#xD;
      clinical anaesthesiology practice.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">July 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2018</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Following informed consent participants are randomised into one of the device groups and general anaesthesia is induced. Primary intubation attempt is carried out with the randomised device. We do not disclose the result of randomisation with our participants prior to anaesthesia induction. Participants are already in surgical anaesthesia with muscle relaxation during the intubation attempt. As providers are the users of the intubation device masking is not possible in this regard. During outcome assessment we plan not to disclose which device was used for a certain group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Intubation time</measure>
    <time_frame>Measured once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.</time_frame>
    <description>Time necessary to secure airway during the induction of general anesthesia. Intubation time is measured from the point the airway device crosses the interdental line until the completion of intubation with insufflated cuffed endotracheal tube (secured airway).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Laryngoscopy time</measure>
    <time_frame>Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.</time_frame>
    <description>Time necessary to achieve best visualisation of the glottic opening.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of glottic opening (POGO) score</measure>
    <time_frame>Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.</time_frame>
    <description>The POGO score describes the best view of the glottic opening compared to the anatomical picture of the glottis. During direct laryngoscopy the investigator registers an approximate socre, while video laryngoscopy records are assessed by an independent investigator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tube insertion time</measure>
    <time_frame>Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.</time_frame>
    <description>Time necessary for the operator to insert the cuffed endotracheal tube inside the proximal part of the trachea through the glottic opening. Tube insertion time is measured after the investigator finished the search for the glottic opening, achieved best view and decided to insert the tube into the trachea until the cuff is inflated and the airway is secured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Primary intubation attempt success rate</measure>
    <time_frame>Measured once after intubation. Up to 120 seconds following the start of intubation attempt.</time_frame>
    <description>All intubation attempts must be finished within 120 seconds or the investigator should give up the attempt and reoxygenize the patient before another attempt. If the investigator finished within the 120 seconds time frame we assess endotracheal tube position by capnography and auscultation. The attempt is regarded successful if the tube is in the right position and the airway is secured.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Intubation;Difficult</condition>
  <arm_group>
    <arm_group_label>Macintosh laryngoscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group intubation attempt is carried out with a standard Macintosh (size 3 or 4) direct laryngoscopy blade.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>KingVision videolaryngoscope</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group intubation attempt is carried out with KingVision videolaryngoscope with a channeled, disposable single-use blade.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VividTrac videolaryngoscope</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this group intubation attempt is carried out with VividTrac Adult model using a smartphone or laptop running the VividVision proprietary software.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Direct laryngoscopy</intervention_name>
    <description>During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a size 4 (or size 3 if necessary) Macintosh blade direct laryngoscope.</description>
    <arm_group_label>Macintosh laryngoscopy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vividtrac videolaryngoscope</intervention_name>
    <description>During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a Vividtrac videolaryngoscope connected to a tablet or smartphone.</description>
    <arm_group_label>VividTrac videolaryngoscope</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>KingVision videolaryngoscope</intervention_name>
    <description>During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a KingVision videolaryngoscope.</description>
    <arm_group_label>KingVision videolaryngoscope</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  over 18 years of age&#xD;
&#xD;
          -  elective intervention&#xD;
&#xD;
          -  no anticipated difficult airway or intubation&#xD;
&#xD;
          -  preoperative anaesthesia risk assessment by American Society of Anaesthesiologists&#xD;
             (ASA) physical status classification: ASA grade I-II&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#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>Bálint Nagy, MD PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Anesthesiology and Intensive Therapy, University of Pécs, Hungary</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Szilárd Rendeki, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Anesthesiology and Intensive Therapy, University of Pécs, Hungary</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lajos Bogár, MD PhD DSc</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Anesthesiology and Intensive Therapy, University of Pécs, Hungary</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gábor Woth, MD PhD</last_name>
    <phone>+36703729231</phone>
    <email>glwoth@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Dóra Keresztes, MD</last_name>
    <phone>+36303875837</phone>
    <email>keresztesdora87@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Pécs, Dept. of Anaesthesia and Intensive Care</name>
      <address>
        <city>Pécs</city>
        <state>Baranya county</state>
        <zip>7622</zip>
        <country>Hungary</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Dóra Keresztes, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Gábor Woth, MD PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Bálint Nagy, MD PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <reference>
    <citation>Rendeki S, Keresztes D, Woth G, Merei A, Rozanovic M, Rendeki M, Farkas J, Muhl D, Nagy B. Comparison of VividTrac(R), Airtraq(R), King Vision(R), Macintosh Laryngoscope and a Custom-Made Videolaryngoscope for difficult and normal airways in mannequins by novices. BMC Anesthesiol. 2017 May 26;17(1):68. doi: 10.1186/s12871-017-0362-y.</citation>
    <PMID>28549421</PMID>
  </reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>May 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pecs</investigator_affiliation>
    <investigator_full_name>Gábor László Woth</investigator_full_name>
    <investigator_title>clinical resident, PhD</investigator_title>
  </responsible_party>
  <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/NCT03271008
org study id: 6328
nct id: NCT03271008
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Comparison of various videolaryngoscope devices (Vividtrac™ and KingVision™) and direct
      laryngoscopy with Macintosh blade regarding laryngoscopy time, intubation time, intubation
      success rate, percentage of visible glottic opening (POGO score) in elective and acute
      clinical anaesthesiology practice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Outcomes Assessor)
masking description: Following informed consent participants are randomised into one of the device groups and general anaesthesia is induced. Primary intubation attempt is carried out with the randomised device. We do not disclose the result of randomisation with our participants prior to anaesthesia induction. Participants are already in surgical anaesthesia with muscle relaxation during the intubation attempt. As providers are the users of the intubation device masking is not possible in this regard. During outcome assessment we plan not to disclose which device was used for a certain group.
measure: Intubation time
time frame: Measured once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
description: Time necessary to secure airway during the induction of general anesthesia. Intubation time is measured from the point the airway device crosses the interdental line until the completion of intubation with insufflated cuffed endotracheal tube (secured airway).
measure: Laryngoscopy time
time frame: Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
description: Time necessary to achieve best visualisation of the glottic opening.
measure: Percentage of glottic opening (POGO) score
time frame: Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
description: The POGO score describes the best view of the glottic opening compared to the anatomical picture of the glottis. During direct laryngoscopy the investigator registers an approximate socre, while video laryngoscopy records are assessed by an independent investigator.
measure: Tube insertion time
time frame: Registered once during the intubation attempt. Up to 120 seconds following the start of intubation attempt.
description: Time necessary for the operator to insert the cuffed endotracheal tube inside the proximal part of the trachea through the glottic opening. Tube insertion time is measured after the investigator finished the search for the glottic opening, achieved best view and decided to insert the tube into the trachea until the cuff is inflated and the airway is secured.
measure: Primary intubation attempt success rate
time frame: Measured once after intubation. Up to 120 seconds following the start of intubation attempt.
description: All intubation attempts must be finished within 120 seconds or the investigator should give up the attempt and reoxygenize the patient before another attempt. If the investigator finished within the 120 seconds time frame we assess endotracheal tube position by capnography and auscultation. The attempt is regarded successful if the tube is in the right position and the airway is secured.
arm group label: Macintosh laryngoscopy
arm group type: Active Comparator
description: In this group intubation attempt is carried out with a standard Macintosh (size 3 or 4) direct laryngoscopy blade.
arm group label: KingVision videolaryngoscope
arm group type: Active Comparator
description: In this group intubation attempt is carried out with KingVision videolaryngoscope with a channeled, disposable single-use blade.
arm group label: VividTrac videolaryngoscope
arm group type: Active Comparator
description: In this group intubation attempt is carried out with VividTrac Adult model using a smartphone or laptop running the VividVision proprietary software.
intervention type: Device
intervention name: Direct laryngoscopy
description: During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a size 4 (or size 3 if necessary) Macintosh blade direct laryngoscope.
arm group label: Macintosh laryngoscopy
intervention type: Device
intervention name: Vividtrac videolaryngoscope
description: During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a Vividtrac videolaryngoscope connected to a tablet or smartphone.
arm group label: VividTrac videolaryngoscope
intervention type: Device
intervention name: KingVision videolaryngoscope
description: During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a KingVision videolaryngoscope.
arm group label: KingVision videolaryngoscope
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bálint Nagy, MD PhD
role: Study Chair
affiliation: Department of Anesthesiology and Intensive Therapy, University of Pécs, Hungary
last name: Szilárd Rendeki, MD
role: Study Chair
affiliation: Department of Anesthesiology and Intensive Therapy, University of Pécs, Hungary
last name: Lajos Bogár, MD PhD DSc
role: Study Chair
affiliation: Department of Anesthesiology and Intensive Therapy, University of Pécs, Hungary
last name: Gábor Woth, MD PhD
phone: +36703729231
email: glwoth@gmail.com
last name: Dóra Keresztes, MD
phone: +36303875837
email: keresztesdora87@gmail.com
facility: 
status: Recruiting
investigator: 
investigator: 
investigator: 
country: Hungary
citation: Rendeki S, Keresztes D, Woth G, Merei A, Rozanovic M, Rendeki M, Farkas J, Muhl D, Nagy B. Comparison of VividTrac(R), Airtraq(R), King Vision(R), Macintosh Laryngoscope and a Custom-Made Videolaryngoscope for difficult and normal airways in mannequins by novices. BMC Anesthesiol. 2017 May 26;17(1):68. doi: 10.1186/s12871-017-0362-y.
PMID: 28549421
responsible party type: Principal Investigator
investigator affiliation: University of Pecs
investigator full name: Gábor László Woth
investigator title: clinical resident, PhD
sharing ipd: No