<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/NCT01692535</url>
  </required_header>
  <id_info>
    <org_study_id>106/12</org_study_id>
    <nct_id>NCT01692535</nct_id>
  </id_info>
  <brief_title>Evaluation of Video Laryngoscopes in Difficult Airway</brief_title>
  <acronym>SWIVIT I</acronym>
  <official_title>Multicenter Study Evaluating Video Laryngoscopes: The Swiss Video-Intubation Trial (SWIVIT I)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Centre Hospitalier Universitaire Vaudois</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital, Geneva</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this multicenter study the investigators are going to evaluate the use of six different&#xD;
      videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with&#xD;
      intubation. The investigators are hypothesizing that these six videolaryngoscopes will&#xD;
      succeed for intubation at first attempt in at least 90% of all cases using a difficult airway&#xD;
      simulation with extrication collars. As gold standard, a standard Macintosh blade is being&#xD;
      used.&#xD;
&#xD;
      The study consists of 6 arms. Each arm includes 120 patients, sums up to a total of 720&#xD;
      patients.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>First attempt intubation success rate</measure>
    <time_frame>within 180 seconds</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>side effects</measure>
    <time_frame>1h and 1 day after surgery</time_frame>
    <description>sore throat, bleeding, dental injuries</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">720</enrollment>
  <condition>Intubation; Difficult</condition>
  <arm_group>
    <arm_group_label>GlideScope</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intubation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Airtraq</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intubation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>McGrath MAC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intubation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>King Vision</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intubation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>A.P. Advance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intubation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>C-MAC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intubation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intubation</intervention_name>
    <description>Intubation with one of the six videolaryngoscopes</description>
    <arm_group_label>A.P. Advance</arm_group_label>
    <arm_group_label>Airtraq</arm_group_label>
    <arm_group_label>C-MAC</arm_group_label>
    <arm_group_label>GlideScope</arm_group_label>
    <arm_group_label>King Vision</arm_group_label>
    <arm_group_label>McGrath MAC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective surgery with general anesthesia requiring intubation&#xD;
&#xD;
          -  &gt;18years old&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known or presumed difficult airway&#xD;
&#xD;
          -  risk of pulmonary aspiration&#xD;
&#xD;
          -  refusing to participate&#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>Robert Greif, MD MME FERC</last_name>
    <role>Study Chair</role>
    <affiliation>University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopitaux Universitaires de Geneve HUG</name>
      <address>
        <city>Geneva</city>
        <state>GE</state>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois CHUV</name>
      <address>
        <city>Lausanne</city>
        <state>VD</state>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bern University Hospital and University of Bern</name>
      <address>
        <city>Bern</city>
        <zip>3011</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>September 17, 2012</study_first_submitted>
  <study_first_submitted_qc>September 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <last_update_submitted>June 10, 2015</last_update_submitted>
  <last_update_submitted_qc>June 10, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Insel Gruppe AG, University Hospital Bern</investigator_affiliation>
    <investigator_full_name>Lorenz Theiler</investigator_full_name>
    <investigator_title>Principal Investigator</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/NCT01692535
org study id: 106/12
nct id: NCT01692535
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
In this multicenter study the investigators are going to evaluate the use of six different
      videolaryngoscopes in patients undergoing elective surgery requiring general anesthesia with
      intubation. The investigators are hypothesizing that these six videolaryngoscopes will
      succeed for intubation at first attempt in at least 90% of all cases using a difficult airway
      simulation with extrication collars. As gold standard, a standard Macintosh blade is being
      used.

      The study consists of 6 arms. Each arm includes 120 patients, sums up to a total of 720
      patients.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Participant)
measure: First attempt intubation success rate
time frame: within 180 seconds
measure: side effects
time frame: 1h and 1 day after surgery
description: sore throat, bleeding, dental injuries
arm group label: GlideScope
arm group type: Experimental
description: intubation
arm group label: Airtraq
arm group type: Experimental
description: intubation
arm group label: McGrath MAC
arm group type: Experimental
description: intubation
arm group label: King Vision
arm group type: Experimental
description: intubation
arm group label: A.P. Advance
arm group type: Experimental
description: intubation
arm group label: C-MAC
arm group type: Experimental
description: intubation
intervention type: Procedure
intervention name: Intubation
description: Intubation with one of the six videolaryngoscopes
arm group label: A.P. Advance
arm group label: Airtraq
arm group label: C-MAC
arm group label: GlideScope
arm group label: King Vision
arm group label: McGrath MAC
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Greif, MD MME FERC
role: Study Chair
affiliation: University Dept Anesthesiology and Pain Therapy, University of Berne, Switzerland
facility: 
facility: 
facility: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Insel Gruppe AG, University Hospital Bern
investigator full name: Lorenz Theiler
investigator title: Principal Investigator