<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/NCT02253979</url>
  </required_header>
  <id_info>
    <org_study_id>0334-12-RMB_CTIL</org_study_id>
    <nct_id>NCT02253979</nct_id>
  </id_info>
  <brief_title>Comparison of VivaSightTM Double Lumen Tube With a Conventional Double Lumen Tube</brief_title>
  <official_title>Comparison of VivaSightTM Double Lumen Tube With a Conventional Double Lumen Tube in Adult Patients Undergoing Video Assisted Thoracoscopic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The DLT&#xD;
      exact position in the airways is verified by fiber-optic bronchoscopy (FOB) after intubation.&#xD;
      The VivaSight TM DL is a single use left DLT with a camera embedded in the tube's right side&#xD;
      port. This study was designed to compare the VivaSightTM DL to the standard DLT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The&#xD;
      efficiency of the DLT depends on its exact position in the airways, as verified by&#xD;
      fiber-optic bronchoscopy (FOB) after intubation, and re-verified after positioning the&#xD;
      patient on the lateral position. The VivaSight TM DL is a single use left DLT with a camera&#xD;
      embedded in the tube's right side port. The view from the camera appears continuously on a&#xD;
      monitor. This study was designed to compare the VivaSightTM DL to the standard DLT. The&#xD;
      primary end point is the time required for intubation with visual confirmation of DLT&#xD;
      position.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>Phase 4</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time required for endotracheal intubation with visual confirmation of double lumen tube position position.</measure>
    <time_frame>During induction of general anesthesia</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Endotracheal Intubation</condition>
  <condition>Airway Management</condition>
  <condition>One Lung Ventilation</condition>
  <arm_group>
    <arm_group_label>standard double lumen tube</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Intervention: Standard double lumen tube</description>
  </arm_group>
  <arm_group>
    <arm_group_label>VivaSight double lumen tube</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention: VivaSight double lumen tube</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard double lumen tube</intervention_name>
    <description>Endotracheal left side double lumen tube</description>
    <arm_group_label>standard double lumen tube</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VivaSight double lumen tube</intervention_name>
    <description>VivaSight double lumen endotracheal intubation</description>
    <arm_group_label>VivaSight double lumen tube</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients undergoing video assisted thoracoscopic lung lobectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  anticipated difficult intubation, patients who required rapid sequence induction&#xD;
&#xD;
          -  patients with known tracheal pathology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dan Levy-Faber, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Senior Surgeon, Department of Cardio-Thoracic Surgery</affiliation>
  </overall_official>
  <results_reference>
    <citation>Heir JS, Purugganan R, Jackson TA, Norman PH, Cata JP, Kosturakis A, Thakar D. A retrospective evaluation of the use of video-capable double-lumen endotracheal tubes in thoracic surgery. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):870-2. doi: 10.1053/j.jvca.2013.11.011. Epub 2014 Mar 20.</citation>
    <PMID>24656617</PMID>
  </results_reference>
  <results_reference>
    <citation>Inoue S, Nishimine N, Kitaguchi K, Furuya H, Taniguchi S. Double lumen tube location predicts tube malposition and hypoxaemia during one lung ventilation. Br J Anaesth. 2004 Feb;92(2):195-201. doi: 10.1093/bja/aeh055.</citation>
    <PMID>14722168</PMID>
  </results_reference>
  <results_reference>
    <citation>Klein U, Karzai W, Bloos F, Wohlfarth M, Gottschall R, Fritz H, Gugel M, Seifert A. Role of fiberoptic bronchoscopy in conjunction with the use of double-lumen tubes for thoracic anesthesia: a prospective study. Anesthesiology. 1998 Feb;88(2):346-50. doi: 10.1097/00000542-199802000-00012.</citation>
    <PMID>9477054</PMID>
  </results_reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>September 30, 2014</last_update_submitted>
  <last_update_submitted_qc>September 30, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 1, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT02253979
org study id: 0334-12-RMB_CTIL
nct id: NCT02253979
lead sponsor: 
has dmc: Yes
Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The DLT
      exact position in the airways is verified by fiber-optic bronchoscopy (FOB) after intubation.
      The VivaSight TM DL is a single use left DLT with a camera embedded in the tube's right side
      port. This study was designed to compare the VivaSightTM DL to the standard DLT.
Double lumen tube (DLT) is an enotracheal tube that facilitates one lung ventilation. The
      efficiency of the DLT depends on its exact position in the airways, as verified by
      fiber-optic bronchoscopy (FOB) after intubation, and re-verified after positioning the
      patient on the lateral position. The VivaSight TM DL is a single use left DLT with a camera
      embedded in the tube's right side port. The view from the camera appears continuously on a
      monitor. This study was designed to compare the VivaSightTM DL to the standard DLT. The
      primary end point is the time required for intubation with visual confirmation of DLT
      position.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time required for endotracheal intubation with visual confirmation of double lumen tube position position.
time frame: During induction of general anesthesia
arm group label: standard double lumen tube
arm group type: Placebo Comparator
description: Intervention: Standard double lumen tube
arm group label: VivaSight double lumen tube
arm group type: Experimental
description: Intervention: VivaSight double lumen tube
intervention type: Device
intervention name: Standard double lumen tube
description: Endotracheal left side double lumen tube
arm group label: standard double lumen tube
intervention type: Device
intervention name: VivaSight double lumen tube
description: VivaSight double lumen endotracheal intubation
arm group label: VivaSight double lumen tube
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Dan Levy-Faber, Dr.
role: Principal Investigator
affiliation: Senior Surgeon, Department of Cardio-Thoracic Surgery
citation: Heir JS, Purugganan R, Jackson TA, Norman PH, Cata JP, Kosturakis A, Thakar D. A retrospective evaluation of the use of video-capable double-lumen endotracheal tubes in thoracic surgery. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):870-2. doi: 10.1053/j.jvca.2013.11.011. Epub 2014 Mar 20.
PMID: 24656617
citation: Inoue S, Nishimine N, Kitaguchi K, Furuya H, Taniguchi S. Double lumen tube location predicts tube malposition and hypoxaemia during one lung ventilation. Br J Anaesth. 2004 Feb;92(2):195-201. doi: 10.1093/bja/aeh055.
PMID: 14722168
citation: Klein U, Karzai W, Bloos F, Wohlfarth M, Gottschall R, Fritz H, Gugel M, Seifert A. Role of fiberoptic bronchoscopy in conjunction with the use of double-lumen tubes for thoracic anesthesia: a prospective study. Anesthesiology. 1998 Feb;88(2):346-50. doi: 10.1097/00000542-199802000-00012.
PMID: 9477054
responsible party type: Sponsor