<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/NCT02220231</url>
  </required_header>
  <id_info>
    <org_study_id>4-2014-0492</org_study_id>
    <nct_id>NCT02220231</nct_id>
  </id_info>
  <brief_title>Echocardiographic Evaluation of the Change on Pulmonary Blood Flow and Cardiac Function Induced by Capnothorax During One Lung Ventilation</brief_title>
  <official_title>Echocardiographic Evaluation of the Change on Pulmonary Blood Flow and Cardiac Function Induced by Capnothorax During One Lung Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Video-assisted thoracoscopic extended thymectomy (VATET) is a minimally-invasive method for&#xD;
      excision of mediastinal mass instead of open thymectomy. The iatrogenic capnothorax with&#xD;
      one-lung ventilation during VATET may cause hemodynamic instability due to the compression of&#xD;
      intrathoracic structures. The purpose of this study is to evaluate the effects of capnothorax&#xD;
      on the pulmonary blood flow and cardiac function during the VATET by using the&#xD;
      transesophageal echocardiography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Video-assisted thoracoscopic extended thymectomy (VATET) is a minimally-invasive method for&#xD;
      excision of mediastinal mass instead of open thymectomy. The iatrogenic capnothorax with&#xD;
      one-lung ventilation during VATET may cause hemodynamic instability due to the compression of&#xD;
      intrathoracic structures. The purpose of this study is to evaluate the effects of capnothorax&#xD;
      on the pulmonary blood flow and cardiac function during the VATET by using the&#xD;
      transesophageal echocardiography&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The changes of the echocardiographic indices</measure>
    <time_frame>four time points during the operation. (1)10 min after induction (baseline); (2) 1 min after CO2 insufflation; (3)10 min after of CO2 insufflation; and (4)20 min after CO2 insufflation</time_frame>
    <description>pulmonary blood flow = PVA(cross sectional area of LUPV) x VTI(velocity time integral) x HR , Fractional area change = [(LVAd-LVAs)/LVAd] × 100 Ejection fraction = [(LVEDV(LV end-diastolic volume) -LVESV(LV end-systolic volume)/LVEDV] × 100</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The changes of the oxygenation and respiratory dynamic parameters</measure>
    <time_frame>four time points during the operation, an expected average of 3 hours. (1)10 min after induction (baseline); (2) 1 min after CO2 insufflation; (3)10 min after of CO2 insufflation; and (4)20 min after CO2 insufflation</time_frame>
    <description>shunt fraction Qs/Qt = (CcO2- CaO2)/(CcO2- CvO2) CcO2 = Hgb x 1.34 x ScO2 + PcO2 x 0.003, lung compliance : Compliance= Vt / Pplat, physiologic dead space : Vd/Vt = 1.14 x (PaCO2 - PETCO2)/PaCO2- 0.005</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Mediastinal Tumors</condition>
  <arm_group>
    <arm_group_label>capnothorax group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After patient positioning, the capnothorax will be created by insufflation of carbon dioxide in patients undergoing video-assisted thoracoscopic extended thymectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>capnothorax</intervention_name>
    <description>After patient positioning, the capnothorax will be created by insufflation of carbon dioxide in patients undergoing video-assisted thoracoscopic extended thymectomy.</description>
    <arm_group_label>capnothorax group</arm_group_label>
    <other_name>VATET, capnothorax, TEE</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Above 20 years of age.&#xD;
&#xD;
          2. American Society of Anesthesiologists (ASA) Physical Status I, II, III.&#xD;
&#xD;
          3. Thoracic surgical procedure (video-assisted thoracoscopic extended thymectomy )&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Severe functional liver or kidney disease&#xD;
&#xD;
          2. Diagnosed HF ( NYHA class &gt;3)&#xD;
&#xD;
          3. Arrhythmia or received treatment with antiarrhythmic drug .&#xD;
&#xD;
          4. Exceed BMI &gt; 30 kg/ m2&#xD;
&#xD;
          5. COPD&#xD;
&#xD;
          6. Pathologic esophageal lesion (esophageal stricture or varix )&#xD;
&#xD;
          7. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 19, 2014</study_first_posted>
  <last_update_submitted>April 16, 2015</last_update_submitted>
  <last_update_submitted_qc>April 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 17, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mediastinal mass, one-lung ventilation, capnothorax, transesophageal echocardiography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mediastinal Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT02220231
org study id: 4-2014-0492
nct id: NCT02220231
lead sponsor: 
has dmc: No
Video-assisted thoracoscopic extended thymectomy (VATET) is a minimally-invasive method for
      excision of mediastinal mass instead of open thymectomy. The iatrogenic capnothorax with
      one-lung ventilation during VATET may cause hemodynamic instability due to the compression of
      intrathoracic structures. The purpose of this study is to evaluate the effects of capnothorax
      on the pulmonary blood flow and cardiac function during the VATET by using the
      transesophageal echocardiography.
Video-assisted thoracoscopic extended thymectomy (VATET) is a minimally-invasive method for
      excision of mediastinal mass instead of open thymectomy. The iatrogenic capnothorax with
      one-lung ventilation during VATET may cause hemodynamic instability due to the compression of
      intrathoracic structures. The purpose of this study is to evaluate the effects of capnothorax
      on the pulmonary blood flow and cardiac function during the VATET by using the
      transesophageal echocardiography
allocation: N/A
intervention model: Single Group Assignment
masking: None (Open Label)
measure: The changes of the echocardiographic indices
time frame: four time points during the operation. (1)10 min after induction (baseline); (2) 1 min after CO2 insufflation; (3)10 min after of CO2 insufflation; and (4)20 min after CO2 insufflation
description: pulmonary blood flow = PVA(cross sectional area of LUPV) x VTI(velocity time integral) x HR , Fractional area change = [(LVAd-LVAs)/LVAd] × 100 Ejection fraction = [(LVEDV(LV end-diastolic volume) -LVESV(LV end-systolic volume)/LVEDV] × 100
measure: The changes of the oxygenation and respiratory dynamic parameters
time frame: four time points during the operation, an expected average of 3 hours. (1)10 min after induction (baseline); (2) 1 min after CO2 insufflation; (3)10 min after of CO2 insufflation; and (4)20 min after CO2 insufflation
description: shunt fraction Qs/Qt = (CcO2- CaO2)/(CcO2- CvO2) CcO2 = Hgb x 1.34 x ScO2 + PcO2 x 0.003, lung compliance : Compliance= Vt / Pplat, physiologic dead space : Vd/Vt = 1.14 x (PaCO2 - PETCO2)/PaCO2- 0.005
arm group label: capnothorax group
arm group type: Experimental
description: After patient positioning, the capnothorax will be created by insufflation of carbon dioxide in patients undergoing video-assisted thoracoscopic extended thymectomy.
intervention type: Procedure
intervention name: capnothorax
description: After patient positioning, the capnothorax will be created by insufflation of carbon dioxide in patients undergoing video-assisted thoracoscopic extended thymectomy.
arm group label: capnothorax group
other name: VATET, capnothorax, TEE
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
responsible party type: Sponsor
mesh term: Mediastinal Neoplasms