<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/NCT03817879</url>
  </required_header>
  <id_info>
    <org_study_id>CIS-009</org_study_id>
    <nct_id>NCT03817879</nct_id>
  </id_info>
  <brief_title>Double-lumen Tubes (DLT) - Health Economic Study</brief_title>
  <official_title>A Randomized Controlled Study Comparing the VivaSight Double-lumen Tube With a Conventional Double-lumen Tube in Adult Patients Undergoing Thoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ambu A/S</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ambu A/S</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to make a health economic evaluation comparing novice physicians use&#xD;
      of VivaSight double-lumen tube and a conventional double-lumen tube for single-lung&#xD;
      ventilation during thoracic surgery at a teaching hospital. The hypothesis is, that both&#xD;
      double-lumen tubes are equally cost-effective and the the incidence of fiberoptic&#xD;
      bronchoscope use it the same for both tubes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, controlled single-centre investigation comparing the VivaSight double-lumen&#xD;
      tube and the conventional double-lumen tube at a teaching hospital. A pilot study including&#xD;
      up to 10 subjects will be performed prior to the investigation is initiated. The&#xD;
      investigation will include a total of 50 adult subjects (25 subjects in each group) admitted&#xD;
      to the investigational site with established indication of single lung ventilation.&#xD;
&#xD;
      The objective of the investigation is to compare the number of times the tube position needs&#xD;
      to be verified with a scope and relevant costs between VivaSight double lumen tube and&#xD;
      conventional double lument tube in a cost-effectiveness analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2018</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 2019</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>Health Services Research</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Times Bronchoscope is Used</measure>
    <time_frame>During procedure, up to 4 hours</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intubation Time</measure>
    <time_frame>During procedure, up to 4 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Intubation Attempts</measure>
    <time_frame>During procedure, up to 4 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Time the Tube Was Repositioned</measure>
    <time_frame>During procedure, up to 4 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Times Repositioning of the Tube Was Prevented</measure>
    <time_frame>During procedure, up to 4 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost Per Procedure</measure>
    <time_frame>An average of 1 year</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Obtain User Perspective of the Device (VivaSight Double Lumen Tube or Conventional Double Lumen Tube) Used During Procedure.</measure>
    <time_frame>During procedure, up to 4 hours</time_frame>
    <description>Qualitative assessment (face-validated and testet during pilot test) using a five-point scale (1: very easy/very good, 3: acceptable, 5: very difficult/very poor)</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Reported Post Operative Outcomes</measure>
    <time_frame>Within 48 hours after the procedure</time_frame>
    <description>Qualitative assessment (face-validated and testet during pilot test) using a questionnaire registrering postoperative outcomes (Yes/No) and degree of postoperative outcomes (mild/moderate/severe)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Single Lung Ventilation</condition>
  <condition>Thoracic Surgery</condition>
  <condition>Anesthesia</condition>
  <condition>Cost-effectiveness</condition>
  <arm_group>
    <arm_group_label>VivaSight double-lumen tube</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional double-lumen tube</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>VivaSight double-lumen tube for single-lung ventilation</intervention_name>
    <description>Procedure using a tube with a camera</description>
    <arm_group_label>VivaSight double-lumen tube</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional double-lument tube for single-lung ventilation</intervention_name>
    <description>Procedure using a tube without a camera</description>
    <arm_group_label>Conventional double-lumen tube</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Oral explanation of the investigation and Patient Information has been given to the&#xD;
             subject or legal representative&#xD;
&#xD;
          -  The subject or legal representative has signed the Informed Consent&#xD;
&#xD;
          -  The subject is admitted at Odense University Hospital (OUH), department V&#xD;
&#xD;
          -  Subjects evaluated as eligible for single-lung ventilation with the use of a left&#xD;
             sided DLT&#xD;
&#xD;
          -  Subjects &gt; 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with known tracheobronchial anatomic anomalies&#xD;
&#xD;
          -  Subjects going for emergency procedures&#xD;
&#xD;
          -  Subjects with anticipated difficult airways&#xD;
&#xD;
          -  Subjects with known tracheal pathology&#xD;
&#xD;
          -  Subjects requiring rapid sequence induction&#xD;
&#xD;
          -  Surgeries in which other lung isolation devices or techniques may be warranted (e.g.&#xD;
             tracheostomy, nasal intubation, bronchial blockers)&#xD;
&#xD;
          -  Subjects who cannot be intubated with a double-lumen tube (VivaSight-DL or&#xD;
             conventional DLT)&#xD;
&#xD;
          -  Subjects requiring a right-sided DLT&#xD;
&#xD;
          -  Subjects who had participated in the study before&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Larsen S, Holm JH, Sauer TN, Andersen C. A Cost-Effectiveness Analysis Comparing the VivaSight Double-Lumen Tube and a Conventional Double-Lumen Tube in Adult Patients Undergoing Thoracic Surgery Involving One-Lung Ventilation. Pharmacoecon Open. 2020 Mar;4(1):159-169. doi: 10.1007/s41669-019-0163-y.</citation>
    <PMID>31297752</PMID>
  </reference>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <results_first_submitted>October 14, 2019</results_first_submitted>
  <results_first_submitted_qc>February 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 13, 2020</results_first_posted>
  <last_update_submitted>February 3, 2020</last_update_submitted>
  <last_update_submitted_qc>February 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data will described in groups</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 26, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/79/NCT03817879/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>VivaSight Double-lumen Tube</title>
          <description>VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera</description>
        </group>
        <group group_id="P2">
          <title>Conventional Double-lumen Tube</title>
          <description>Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Drop out</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>VivaSight Double-lumen Tube</title>
          <description>VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera</description>
        </group>
        <group group_id="B2">
          <title>Conventional Double-lumen Tube</title>
          <description>Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="30"/>
            <count group_id="B2" value="22"/>
            <count group_id="B3" value="52"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="65.80" spread="10.02"/>
                    <measurement group_id="B2" value="68.50" spread="7.16"/>
                    <measurement group_id="B3" value="66.94" spread="8.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>cm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="172.47" spread="9.32"/>
                    <measurement group_id="B2" value="172.77" spread="9.56"/>
                    <measurement group_id="B3" value="172.60" spread="9.33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.73" spread="19.14"/>
                    <measurement group_id="B2" value="76.23" spread="17.12"/>
                    <measurement group_id="B3" value="75.37" spread="18.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Surgical lung</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Left</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="22"/>
                    <count group_id="B3" value="52"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Times Bronchoscope is Used</title>
        <time_frame>During procedure, up to 4 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>VivaSight Double-lumen Tube</title>
            <description>VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera</description>
          </group>
          <group group_id="O2">
            <title>Conventional Double-lumen Tube</title>
            <description>Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Times Bronchoscope is Used</title>
          <units>Reported uses of bronchoscopes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.07" spread="0.25"/>
                    <measurement group_id="O2" value="3.14" spread="1.58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intubation Time</title>
        <time_frame>During procedure, up to 4 hours</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Intubation Attempts</title>
        <time_frame>During procedure, up to 4 hours</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Time the Tube Was Repositioned</title>
        <time_frame>During procedure, up to 4 hours</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Times Repositioning of the Tube Was Prevented</title>
        <time_frame>During procedure, up to 4 hours</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cost Per Procedure</title>
        <time_frame>An average of 1 year</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Obtain User Perspective of the Device (VivaSight Double Lumen Tube or Conventional Double Lumen Tube) Used During Procedure.</title>
        <description>Qualitative assessment (face-validated and testet during pilot test) using a five-point scale (1: very easy/very good, 3: acceptable, 5: very difficult/very poor)</description>
        <time_frame>During procedure, up to 4 hours</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Patient Reported Post Operative Outcomes</title>
        <description>Qualitative assessment (face-validated and testet during pilot test) using a questionnaire registrering postoperative outcomes (Yes/No) and degree of postoperative outcomes (mild/moderate/severe)</description>
        <time_frame>Within 48 hours after the procedure</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 48 hours post procedure.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>VivaSight Double-lumen Tube</title>
          <description>VivaSight double-lumen tube for single-lung ventilation: Procedure using a tube with a camera</description>
        </group>
        <group group_id="E2">
          <title>Conventional Double-lumen Tube</title>
          <description>Conventional double-lument tube for single-lung ventilation: Procedure using a tube without a camera</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Anna Charlotte Lundgaard</name_or_title>
      <organization>Ambu A/S</organization>
      <phone>+4529643748</phone>
      <email>aclu@ambu.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03817879
org study id: CIS-009
nct id: NCT03817879
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
is us export: No
The aim of this study is to make a health economic evaluation comparing novice physicians use
      of VivaSight double-lumen tube and a conventional double-lumen tube for single-lung
      ventilation during thoracic surgery at a teaching hospital. The hypothesis is, that both
      double-lumen tubes are equally cost-effective and the the incidence of fiberoptic
      bronchoscope use it the same for both tubes.
A randomized, controlled single-centre investigation comparing the VivaSight double-lumen
      tube and the conventional double-lumen tube at a teaching hospital. A pilot study including
      up to 10 subjects will be performed prior to the investigation is initiated. The
      investigation will include a total of 50 adult subjects (25 subjects in each group) admitted
      to the investigational site with established indication of single lung ventilation.

      The objective of the investigation is to compare the number of times the tube position needs
      to be verified with a scope and relevant costs between VivaSight double lumen tube and
      conventional double lument tube in a cost-effectiveness analysis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Single (Participant)
measure: Number of Times Bronchoscope is Used
time frame: During procedure, up to 4 hours
measure: Intubation Time
time frame: During procedure, up to 4 hours
measure: Number of Intubation Attempts
time frame: During procedure, up to 4 hours
measure: Number of Time the Tube Was Repositioned
time frame: During procedure, up to 4 hours
measure: Number of Times Repositioning of the Tube Was Prevented
time frame: During procedure, up to 4 hours
measure: Cost Per Procedure
time frame: An average of 1 year
measure: Obtain User Perspective of the Device (VivaSight Double Lumen Tube or Conventional Double Lumen Tube) Used During Procedure.
time frame: During procedure, up to 4 hours
description: Qualitative assessment (face-validated and testet during pilot test) using a five-point scale (1: very easy/very good, 3: acceptable, 5: very difficult/very poor)
measure: Patient Reported Post Operative Outcomes
time frame: Within 48 hours after the procedure
description: Qualitative assessment (face-validated and testet during pilot test) using a questionnaire registrering postoperative outcomes (Yes/No) and degree of postoperative outcomes (mild/moderate/severe)
arm group label: VivaSight double-lumen tube
arm group type: Experimental
arm group label: Conventional double-lumen tube
arm group type: Active Comparator
intervention type: Procedure
intervention name: VivaSight double-lumen tube for single-lung ventilation
description: Procedure using a tube with a camera
arm group label: VivaSight double-lumen tube
intervention type: Procedure
intervention name: Conventional double-lument tube for single-lung ventilation
description: Procedure using a tube without a camera
arm group label: Conventional double-lumen tube
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
citation: Larsen S, Holm JH, Sauer TN, Andersen C. A Cost-Effectiveness Analysis Comparing the VivaSight Double-Lumen Tube and a Conventional Double-Lumen Tube in Adult Patients Undergoing Thoracic Surgery Involving One-Lung Ventilation. Pharmacoecon Open. 2020 Mar;4(1):159-169. doi: 10.1007/s41669-019-0163-y.
PMID: 31297752
responsible party type: Sponsor
sharing ipd: No
ipd description: Data will described in groups
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 