<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/NCT03016858</url>
  </required_header>
  <id_info>
    <org_study_id>SVA-001</org_study_id>
    <nct_id>NCT03016858</nct_id>
  </id_info>
  <brief_title>Clinical Trial of Thoracoscopic Bullectomy Surgery Under Spontaneous Ventilating Anesthesia</brief_title>
  <official_title>Multicenter Randomized Controlled Clinical Trial of Thoracoscopic Bullectomy Surgery Under Nonintubated Intravenous Anesthesia With Spontaneous Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangzhou Institute of Respiratory Disease</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>First Affiliated Hospital, Sun Yat-Sen University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Taizhou Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Second Affiliated Hospital, South China University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Affiliated Hospital of Southwest Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shenzhen Third People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Jieyang People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Guangzhou Institute of Respiratory Disease</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      With the development of video-assisted thoracoscopic surgery (VATS) techniques and technology&#xD;
      for anesthesia control, non-intubated anesthesia with spontaneous ventilation has been widely&#xD;
      applied in VATS. A multicenter randomized parallel controlled study was applied in this study&#xD;
      to assess the efficacy and safety of thoracoscopic bullectomy surgery under intravenous&#xD;
      anesthesia with spontaneous ventilation versus tracheal intubation general anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intubated anesthesia with single lung mechanical ventilation (IASLV) is considered the&#xD;
      standard of care in VATS. However, this type of anesthesia has been associated with several&#xD;
      adverse effects, which can trigger complications and increase the overall surgical risk. In&#xD;
      order to avoid intubated-anesthesia-related adverse effects, nonintubated strategies have&#xD;
      been proposed in recent years.Encouraged by the satisfactory results with a preliminary&#xD;
      experience of nonintubated VATS, the multicenter randomized parallel controlled study is&#xD;
      established to comparatively analyze the outcome of patients undergoing either nonintubated&#xD;
      intravenous anesthesia with spontaneous ventilation (NIIASV) or IASLV VATS thoracoscopic&#xD;
      bullectomy surgery，especially in complication rate, safety during operation, muscle recovery&#xD;
      after surgery, the difference the postoperative hospitalization time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">May 2019</primary_completion_date>
  <phase>Phase 3</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>numbers of participants with postoperative respiratory and cardiovascular complications</measure>
    <time_frame>from operation to discharging, an average of 1 week</time_frame>
    <description>The numbers of participants with postoperative respiratory and cardiovascular complications will be reported. The postoperative complications include postoperative respiratory complications(e.g., air leaks, lung infections, atelectasis, and bronchospasm and respiratory failure), postoperative cardiovascular complications(e.g., arrhythmias, myocardial infarction, cardiac failure) , intubated related complications(e.g., hoarseness, sore throat, and irritating cough), and other undefined complications</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>numbers of participants with unstable vital signs, hypoxemia or hypercapnia intraoperatively</measure>
    <time_frame>during the surgical operation, an average of 1 hour</time_frame>
    <description>the numbers of participants with unstable vital signs or hypoxemia/hypercapnia will be reported. The vital signs will be monitored through the whole surgical operation(including heart rating in beat per minute, temperature in degree Celsius, respiratory in breaths per minute and blood pressure in oxygen in millimetres of mercury ), and blood gas analysis((including partial pressure of oxygen in millimetres of mercury, partial pressure of carbon dioxide in millimetres of mercury, and so on) will be tested every 30 mins during the operation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>numbers of participants with anesthesia conversion intraoperatively in nonintubated group</measure>
    <time_frame>during the surgical operation, an average of 1 hour</time_frame>
    <description>The numbers of participants undergoing conversion from nonintubated anaesthesia to intubated anaesthesia in nonintubated group will be reported because of hypoxemia, carbohemia, bleeding or other undefined reasons.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>numbers of participants with postoperative complications</measure>
    <time_frame>from operation to discharging, an average of 1 week</time_frame>
    <description>The numbers of participants with any postoperative complications will be reported.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>the postoperative hospitalization time of every participant</measure>
    <time_frame>through the postoperative hospitalization time, an average of 1 week)</time_frame>
    <description>the postoperative time point of participants meeting the discharging criteria: body T°&lt;37.5℃, degree of blood oxygen saturation on room air&gt;95%, no complications requiring in-hospital treatment, full lung re-expansion after chest tube removal, and white blood cell count&lt;10×109/L.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">320</enrollment>
  <condition>Stability During Surgical Operation</condition>
  <condition>Complication, Postoperative</condition>
  <condition>Postoperative Hospitalization Time</condition>
  <arm_group>
    <arm_group_label>NIIASV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>undergoing Thoracoscopic Bullectomy Surgery under nonintubated intravenous anesthesia with spontaneous ventilation(NIIASV)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>IASLV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>undergoing Thoracoscopic Bullectomy Surgery under intubated anesthesia with single-lung mechanical ventilation(IASLV)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thoracoscopic Bullectomy Surgery</intervention_name>
    <description>undergoing the Thoracoscopic Bullectomy Surgery</description>
    <arm_group_label>IASLV</arm_group_label>
    <arm_group_label>NIIASV</arm_group_label>
    <other_name>video-assisted thoracoscopic bulla resection</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  volunteering to participate in clinical trials and having the ability of&#xD;
             responsibility can be signed informed consent.&#xD;
&#xD;
          -  16-50 years old&#xD;
&#xD;
          -  preoperative chest CT diagnosed with &quot;localized lung bulla&quot; and needing surgical&#xD;
             treatment&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group(ECOG) score standard ≤ 1&#xD;
&#xD;
          -  ASA（American Society of Anesthesiologists score） ≤ 2&#xD;
&#xD;
          -  Heart ejection fraction( EF)≥ 50%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusing to participate in clinical trials&#xD;
&#xD;
          -  A history of tuberculosis or other diseases could cause pleural adhesion or more&#xD;
             pleural effusion&#xD;
&#xD;
          -  BMI ≥ 25 kg/m^2&#xD;
&#xD;
          -  other not suitable situations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jun Liu, Ph.D, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>The First Affiliated Hospital of Guangzhou Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fei Cui, Ph.D, M.D.</last_name>
    <phone>08618902301212</phone>
    <phone_ext>08602083062822</phone_ext>
    <email>cuidavil@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>the First Affiliated Hospital of Guangzhou Medical university</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>
  <reference>
    <citation>Cui F, Liu J, Li S, Yin W, Xin X, Shao W, He J. Tubeless video-assisted thoracoscopic surgery (VATS) under non-intubated, intravenous anesthesia with spontaneous ventilation and no placement of chest tube postoperatively. J Thorac Dis. 2016 Aug;8(8):2226-32. doi: 10.21037/jtd.2016.08.02.</citation>
    <PMID>27621880</PMID>
  </reference>
  <reference>
    <citation>Peng G, Cui F, Ang KL, Zhang X, Yin W, Shao W, Dong Q, Liang L, He J. Non-intubated combined with video-assisted thoracoscopic in carinal reconstruction. J Thorac Dis. 2016 Mar;8(3):586-93. doi: 10.21037/jtd.2016.01.58. Erratum In: J Thorac Dis. 2016 Jul;8(7):E641.</citation>
    <PMID>27076956</PMID>
  </reference>
  <reference>
    <citation>Li S, Liu J, He J, Dong Q, Liang L, Cui F, Pan H, He J. Video-assisted transthoracic surgery resection of a tracheal mass and reconstruction of trachea under non-intubated anesthesia with spontaneous breathing. J Thorac Dis. 2016 Mar;8(3):575-85. doi: 10.21037/jtd.2016.01.62.</citation>
    <PMID>27076955</PMID>
  </reference>
  <reference>
    <citation>Liu J, Cui F, He J. Non-intubated video-assisted thoracoscopic surgery anatomical resections: a new perspective for treatment of lung cancer. Ann Transl Med. 2015 May;3(8):102. doi: 10.3978/j.issn.2305-5839.2015.04.18.</citation>
    <PMID>26046043</PMID>
  </reference>
  <reference>
    <citation>Li S, Cui F, Liu J, Xu X, Shao W, Yin W, Chen H, He J. Nonintubated uniportal video-assisted thoracoscopic surgery for primary spontaneous pneumothorax. Chin J Cancer Res. 2015 Apr;27(2):197-202. doi: 10.3978/j.issn.1000-9604.2015.03.01.</citation>
    <PMID>25937782</PMID>
  </reference>
  <reference>
    <citation>Dong Q, Liang L, Li Y, Liu J, Yin W, Chen H, Xu X, Shao W, He J. Anesthesia with nontracheal intubation in thoracic surgery. J Thorac Dis. 2012 Apr 1;4(2):126-30. doi: 10.3978/j.issn.2072-1439.2012.03.10.</citation>
    <PMID>22833817</PMID>
  </reference>
  <reference>
    <citation>Liu J, Cui F, Pompeo E, Gonzalez-Rivas D, Chen H, Yin W, Shao W, Li S, Pan H, Shen J, Hamblin L, He J. The impact of non-intubated versus intubated anaesthesia on early outcomes of video-assisted thoracoscopic anatomical resection in non-small-cell lung cancer: a propensity score matching analysis. Eur J Cardiothorac Surg. 2016 Nov;50(5):920-925. doi: 10.1093/ejcts/ezw160. Epub 2016 May 10.</citation>
    <PMID>27165771</PMID>
  </reference>
  <reference>
    <citation>Guo Z, Yin W, Zhang X, Xu X, Liu H, Shao W, Liu J, Chen H, He J. Primary spontaneous pneumothorax: simultaneous treatment by bilateral non-intubated videothoracoscopy. Interact Cardiovasc Thorac Surg. 2016 Aug;23(2):196-201. doi: 10.1093/icvts/ivw123. Epub 2016 May 10.</citation>
    <PMID>27165732</PMID>
  </reference>
  <reference>
    <citation>Liu J, Cui F, Li S, Chen H, Shao W, Liang L, Yin W, Lin Y, He J. Nonintubated video-assisted thoracoscopic surgery under epidural anesthesia compared with conventional anesthetic option: a randomized control study. Surg Innov. 2015 Apr;22(2):123-30. doi: 10.1177/1553350614531662. Epub 2014 May 12.</citation>
    <PMID>24821259</PMID>
  </reference>
  <reference>
    <citation>Chen JS, Cheng YJ, Hung MH, Tseng YD, Chen KC, Lee YC. Nonintubated thoracoscopic lobectomy for lung cancer. Ann Surg. 2011 Dec;254(6):1038-43. doi: 10.1097/SLA.0b013e31822ed19b.</citation>
    <PMID>21869676</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>January 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>January 27, 2019</last_update_submitted>
  <last_update_submitted_qc>January 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</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>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03016858
org study id: SVA-001
nct id: NCT03016858
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
With the development of video-assisted thoracoscopic surgery (VATS) techniques and technology
      for anesthesia control, non-intubated anesthesia with spontaneous ventilation has been widely
      applied in VATS. A multicenter randomized parallel controlled study was applied in this study
      to assess the efficacy and safety of thoracoscopic bullectomy surgery under intravenous
      anesthesia with spontaneous ventilation versus tracheal intubation general anesthesia.
Intubated anesthesia with single lung mechanical ventilation (IASLV) is considered the
      standard of care in VATS. However, this type of anesthesia has been associated with several
      adverse effects, which can trigger complications and increase the overall surgical risk. In
      order to avoid intubated-anesthesia-related adverse effects, nonintubated strategies have
      been proposed in recent years.Encouraged by the satisfactory results with a preliminary
      experience of nonintubated VATS, the multicenter randomized parallel controlled study is
      established to comparatively analyze the outcome of patients undergoing either nonintubated
      intravenous anesthesia with spontaneous ventilation (NIIASV) or IASLV VATS thoracoscopic
      bullectomy surgery，especially in complication rate, safety during operation, muscle recovery
      after surgery, the difference the postoperative hospitalization time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: numbers of participants with postoperative respiratory and cardiovascular complications
time frame: from operation to discharging, an average of 1 week
description: The numbers of participants with postoperative respiratory and cardiovascular complications will be reported. The postoperative complications include postoperative respiratory complications(e.g., air leaks, lung infections, atelectasis, and bronchospasm and respiratory failure), postoperative cardiovascular complications(e.g., arrhythmias, myocardial infarction, cardiac failure) , intubated related complications(e.g., hoarseness, sore throat, and irritating cough), and other undefined complications
measure: numbers of participants with unstable vital signs, hypoxemia or hypercapnia intraoperatively
time frame: during the surgical operation, an average of 1 hour
description: the numbers of participants with unstable vital signs or hypoxemia/hypercapnia will be reported. The vital signs will be monitored through the whole surgical operation(including heart rating in beat per minute, temperature in degree Celsius, respiratory in breaths per minute and blood pressure in oxygen in millimetres of mercury ), and blood gas analysis((including partial pressure of oxygen in millimetres of mercury, partial pressure of carbon dioxide in millimetres of mercury, and so on) will be tested every 30 mins during the operation.
measure: numbers of participants with anesthesia conversion intraoperatively in nonintubated group
time frame: during the surgical operation, an average of 1 hour
description: The numbers of participants undergoing conversion from nonintubated anaesthesia to intubated anaesthesia in nonintubated group will be reported because of hypoxemia, carbohemia, bleeding or other undefined reasons.
measure: numbers of participants with postoperative complications
time frame: from operation to discharging, an average of 1 week
description: The numbers of participants with any postoperative complications will be reported.
measure: the postoperative hospitalization time of every participant
time frame: through the postoperative hospitalization time, an average of 1 week)
description: the postoperative time point of participants meeting the discharging criteria: body T°<37.5℃, degree of blood oxygen saturation on room air>95%, no complications requiring in-hospital treatment, full lung re-expansion after chest tube removal, and white blood cell count<10×109/L.
arm group label: NIIASV
arm group type: Experimental
description: undergoing Thoracoscopic Bullectomy Surgery under nonintubated intravenous anesthesia with spontaneous ventilation(NIIASV)
arm group label: IASLV
arm group type: Active Comparator
description: undergoing Thoracoscopic Bullectomy Surgery under intubated anesthesia with single-lung mechanical ventilation(IASLV)
intervention type: Procedure
intervention name: Thoracoscopic Bullectomy Surgery
description: undergoing the Thoracoscopic Bullectomy Surgery
arm group label: IASLV
arm group label: NIIASV
other name: video-assisted thoracoscopic bulla resection
criteria: 
gender: All
minimum age: 16 Years
maximum age: 50 Years
healthy volunteers: No
last name: Jun Liu, Ph.D, M.D.
role: Study Chair
affiliation: The First Affiliated Hospital of Guangzhou Medical University
last name: Fei Cui, Ph.D, M.D.
phone: 08618902301212
phone ext: 08602083062822
email: cuidavil@hotmail.com
facility: 
status: Recruiting
contact: 
country: China
citation: Cui F, Liu J, Li S, Yin W, Xin X, Shao W, He J. Tubeless video-assisted thoracoscopic surgery (VATS) under non-intubated, intravenous anesthesia with spontaneous ventilation and no placement of chest tube postoperatively. J Thorac Dis. 2016 Aug;8(8):2226-32. doi: 10.21037/jtd.2016.08.02.
PMID: 27621880
citation: Peng G, Cui F, Ang KL, Zhang X, Yin W, Shao W, Dong Q, Liang L, He J. Non-intubated combined with video-assisted thoracoscopic in carinal reconstruction. J Thorac Dis. 2016 Mar;8(3):586-93. doi: 10.21037/jtd.2016.01.58. Erratum In: J Thorac Dis. 2016 Jul;8(7):E641.
PMID: 27076956
citation: Li S, Liu J, He J, Dong Q, Liang L, Cui F, Pan H, He J. Video-assisted transthoracic surgery resection of a tracheal mass and reconstruction of trachea under non-intubated anesthesia with spontaneous breathing. J Thorac Dis. 2016 Mar;8(3):575-85. doi: 10.21037/jtd.2016.01.62.
PMID: 27076955
citation: Liu J, Cui F, He J. Non-intubated video-assisted thoracoscopic surgery anatomical resections: a new perspective for treatment of lung cancer. Ann Transl Med. 2015 May;3(8):102. doi: 10.3978/j.issn.2305-5839.2015.04.18.
PMID: 26046043
citation: Li S, Cui F, Liu J, Xu X, Shao W, Yin W, Chen H, He J. Nonintubated uniportal video-assisted thoracoscopic surgery for primary spontaneous pneumothorax. Chin J Cancer Res. 2015 Apr;27(2):197-202. doi: 10.3978/j.issn.1000-9604.2015.03.01.
PMID: 25937782
citation: Dong Q, Liang L, Li Y, Liu J, Yin W, Chen H, Xu X, Shao W, He J. Anesthesia with nontracheal intubation in thoracic surgery. J Thorac Dis. 2012 Apr 1;4(2):126-30. doi: 10.3978/j.issn.2072-1439.2012.03.10.
PMID: 22833817
citation: Liu J, Cui F, Pompeo E, Gonzalez-Rivas D, Chen H, Yin W, Shao W, Li S, Pan H, Shen J, Hamblin L, He J. The impact of non-intubated versus intubated anaesthesia on early outcomes of video-assisted thoracoscopic anatomical resection in non-small-cell lung cancer: a propensity score matching analysis. Eur J Cardiothorac Surg. 2016 Nov;50(5):920-925. doi: 10.1093/ejcts/ezw160. Epub 2016 May 10.
PMID: 27165771
citation: Guo Z, Yin W, Zhang X, Xu X, Liu H, Shao W, Liu J, Chen H, He J. Primary spontaneous pneumothorax: simultaneous treatment by bilateral non-intubated videothoracoscopy. Interact Cardiovasc Thorac Surg. 2016 Aug;23(2):196-201. doi: 10.1093/icvts/ivw123. Epub 2016 May 10.
PMID: 27165732
citation: Liu J, Cui F, Li S, Chen H, Shao W, Liang L, Yin W, Lin Y, He J. Nonintubated video-assisted thoracoscopic surgery under epidural anesthesia compared with conventional anesthetic option: a randomized control study. Surg Innov. 2015 Apr;22(2):123-30. doi: 10.1177/1553350614531662. Epub 2014 May 12.
PMID: 24821259
citation: Chen JS, Cheng YJ, Hung MH, Tseng YD, Chen KC, Lee YC. Nonintubated thoracoscopic lobectomy for lung cancer. Ann Surg. 2011 Dec;254(6):1038-43. doi: 10.1097/SLA.0b013e31822ed19b.
PMID: 21869676
responsible party type: Principal Investigator
investigator affiliation: Guangzhou Institute of Respiratory Disease
investigator full name: Jun Liu
investigator title: Professor
mesh term: Postoperative Complications
sharing ipd: No