<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/NCT01677442</url>
  </required_header>
  <id_info>
    <org_study_id>NTEA001</org_study_id>
    <nct_id>NCT01677442</nct_id>
  </id_info>
  <brief_title>Nonintubated Thoracic Epidural Anesthesia Versus Double-lumen Intubated Anesthesia in Video-assisted Thoracic Surgery</brief_title>
  <official_title>Nonintubated Thoracic Epidural Anesthesia Versus Double-lumen Intubated Anesthesia in Video-assisted Thoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou Institute of Respiratory Disease</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangzhou Institute of Respiratory Disease</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare results of general Video-assisted Thoracic Surgery&#xD;
      (VATS) operations under no-intubated thoracic epidural anesthesia (NTEA) versus those of a&#xD;
      control group operated under general anesthesia with double-lumen endotracheal intubation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The thoracoscopic surgery always requires not only an appropriate depth of anaesthesia, but&#xD;
      also a quiet and wide operative field. That's why anaesthesia plays a critical role in&#xD;
      thoracoscopic surgery.&#xD;
&#xD;
      General double-lumen endotracheal intubated anesthesia with one-lung ventilation, has been&#xD;
      accepted mandatory for Video-Assisted Thoracic Surgery (VATS) although several adverse&#xD;
      effects can derive from this type of anesthesia like intubation-related throat injury,&#xD;
      ventilator-induced lung injury, arrhythmia and so on. The investigators hypothesize that VATS&#xD;
      could be performed under the no-intubated thoracic epidural anesthesia (NTEA) to avoid&#xD;
      general anesthesia related risks.&#xD;
&#xD;
      Some cases have been reported to prove the safety and feasibility of NTEA in uncomplicated&#xD;
      VATS. However, the comparison of NTEA and general anesthesia has been rarely investigated in&#xD;
      such a larger magnitude number and such operation varieties. The investigators hypothesize&#xD;
      NTEA could result in less inflammations, lower incidence of complications, less dosage of&#xD;
      antibiotic, faster recovery eventually leading to a shorter hospital stay. For this reason,&#xD;
      the investigators will undertaken a randomized trial comparing results of general VATS&#xD;
      operations under NTEA versus those of a control group operated under general anesthesia with&#xD;
      double-lumen endotracheal intubation.&#xD;
&#xD;
      A total of 500 patients will be included. The study will be performed in the first affiliated&#xD;
      hospital of Guangzhou Medical College.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2011</start_date>
  <completion_date type="Anticipated">July 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2014</primary_completion_date>
  <phase>Phase 1/Phase 2</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>recovery time after intervention of each group</measure>
    <time_frame>7 days</time_frame>
    <description>the time of anesthesia recovery, resumption of oral intake, and the length of hospital stay</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of complications</measure>
    <time_frame>14 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>the inflammation level</measure>
    <time_frame>7 days</time_frame>
    <description>hemogram and some inflammatory markers</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Anaesthesia</condition>
  <condition>Video Assisted Thoracic Surgery</condition>
  <arm_group>
    <arm_group_label>no-intubated group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental: no-intubated thoracic epidural anesthesia Thoracic epidural anesthesia at the T5/T6 thoracic interspace</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intubated group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Active Comparator:double-lumen endotracheal intubated anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>no-intubated thoracic epidural anesthesia</intervention_name>
    <description>VATS under no-intubated thoracic epidural anesthesia</description>
    <arm_group_label>no-intubated group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>double-lumen endotracheal intubated anesthesia</intervention_name>
    <description>VATS under double-lumen endotracheal intubated anesthesia</description>
    <arm_group_label>intubated group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 18 and 65 years old&#xD;
&#xD;
          -  signed inform consent&#xD;
&#xD;
          -  Tumor size &lt; 6 cm without right or left bronchus invasion&#xD;
&#xD;
          -  Predicted FEV 1.0 &gt; 60% or FEV1.0 &gt; 1.5L&#xD;
&#xD;
          -  EF &gt; 50%&#xD;
&#xD;
          -  PCO2 &lt; 50mmHg,PO2 &gt; 60mmHg（without uptaking oxygen）&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychopath patients who cannot cooperate&#xD;
&#xD;
          -  ASA score greater than 3&#xD;
&#xD;
          -  A history of tuberculosis or other signs of intrapleural adhesions&#xD;
&#xD;
          -  spinal malformation&#xD;
&#xD;
          -  Hypovolemia or coagulation disorders&#xD;
&#xD;
          -  BMI &gt; 30&#xD;
&#xD;
          -  Unfavorable reasons judged by anesthesiologist or surgeon&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianxing He, Ph.D, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>Guangzhou Institute of Respiratory Disease</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jun Liu, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Guangzhou Institute of Respiratory Disease</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fei Cui, Ph.D, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangzhou Institute of Respiratory Disease</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jun Liu, MD.</last_name>
    <phone>13808880646</phone>
    <email>cuidavil@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>the First Affiliated Hospital of Guangzhou Medical College</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Fei Cui, MD.,PhD</last_name>
      <phone>08618902301212</phone>
      <email>4641121@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.gyfyy.com/</url>
    <description>Related Info</description>
  </link>
  <verification_date>April 2012</verification_date>
  <study_first_submitted>May 4, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>August 31, 2012</last_update_submitted>
  <last_update_submitted_qc>August 31, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangzhou Institute of Respiratory Disease</investigator_affiliation>
    <investigator_full_name>Jun Liu</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>nonintubated</keyword>
  <keyword>anaesthesia</keyword>
  <keyword>VATS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Dissection</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT01677442
org study id: NTEA001
nct id: NCT01677442
lead sponsor: 
has dmc: Yes
The purpose of this study is to compare results of general Video-assisted Thoracic Surgery
      (VATS) operations under no-intubated thoracic epidural anesthesia (NTEA) versus those of a
      control group operated under general anesthesia with double-lumen endotracheal intubation.
The thoracoscopic surgery always requires not only an appropriate depth of anaesthesia, but
      also a quiet and wide operative field. That's why anaesthesia plays a critical role in
      thoracoscopic surgery.

      General double-lumen endotracheal intubated anesthesia with one-lung ventilation, has been
      accepted mandatory for Video-Assisted Thoracic Surgery (VATS) although several adverse
      effects can derive from this type of anesthesia like intubation-related throat injury,
      ventilator-induced lung injury, arrhythmia and so on. The investigators hypothesize that VATS
      could be performed under the no-intubated thoracic epidural anesthesia (NTEA) to avoid
      general anesthesia related risks.

      Some cases have been reported to prove the safety and feasibility of NTEA in uncomplicated
      VATS. However, the comparison of NTEA and general anesthesia has been rarely investigated in
      such a larger magnitude number and such operation varieties. The investigators hypothesize
      NTEA could result in less inflammations, lower incidence of complications, less dosage of
      antibiotic, faster recovery eventually leading to a shorter hospital stay. For this reason,
      the investigators will undertaken a randomized trial comparing results of general VATS
      operations under NTEA versus those of a control group operated under general anesthesia with
      double-lumen endotracheal intubation.

      A total of 500 patients will be included. The study will be performed in the first affiliated
      hospital of Guangzhou Medical College.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: recovery time after intervention of each group
time frame: 7 days
description: the time of anesthesia recovery, resumption of oral intake, and the length of hospital stay
measure: incidence of complications
time frame: 14 days
measure: the inflammation level
time frame: 7 days
description: hemogram and some inflammatory markers
arm group label: no-intubated group
arm group type: Experimental
description: Experimental: no-intubated thoracic epidural anesthesia Thoracic epidural anesthesia at the T5/T6 thoracic interspace
arm group label: intubated group
arm group type: Active Comparator
description: Active Comparator:double-lumen endotracheal intubated anesthesia
intervention type: Procedure
intervention name: no-intubated thoracic epidural anesthesia
description: VATS under no-intubated thoracic epidural anesthesia
arm group label: no-intubated group
intervention type: Procedure
intervention name: double-lumen endotracheal intubated anesthesia
description: VATS under double-lumen endotracheal intubated anesthesia
arm group label: intubated group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jianxing He, Ph.D, M.D.
role: Study Chair
affiliation: Guangzhou Institute of Respiratory Disease
last name: Jun Liu, M.D.
role: Study Director
affiliation: Guangzhou Institute of Respiratory Disease
last name: Fei Cui, Ph.D, M.D.
role: Principal Investigator
affiliation: Guangzhou Institute of Respiratory Disease
last name: Jun Liu, MD.
phone: 13808880646
email: cuidavil@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
url: http://www.gyfyy.com/
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Guangzhou Institute of Respiratory Disease
investigator full name: Jun Liu
investigator title: Director
mesh term: Aortic Dissection
mesh term: Anesthetics