<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/NCT03802968</url>
  </required_header>
  <id_info>
    <org_study_id>2018-185</org_study_id>
    <nct_id>NCT03802968</nct_id>
  </id_info>
  <brief_title>The Application of Lung Ultrasound Combine With Diaphragm Ultrasound During Thoracic Surgery</brief_title>
  <official_title>The Perioperative Application of Lung Ultrasound Combine With Diaphragm Ultrasound In One-lung Ventilation During Thoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Xuzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Perioperative lung-protective strategies had been advocated in one-lung ventilation but&#xD;
      normal respiratory functions were yet impacted during videoassisted thoracoscopic(VATS)&#xD;
      surgery. The primary aim of this study was to investigate respiratory complications after&#xD;
      OLVby using bedside lung ultrasonography combine with diaphragmatic ultrasonography.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Perioperative lung-protective strategies had been advocated in One-lung Ventilation(OLV) of&#xD;
      videoassisted thoracoscopic(VATS) surgery but normal respiratory functions were yet impacted&#xD;
      during general anesthesia, mechanical ventilation, loss of respiratory muscle tone and&#xD;
      intrathoracic surgery. Lung ultrasonography has been confirmed to be a available tool for&#xD;
      rapid confirming atelectasis, pleural effusion , pneumonia and pneumothorax. Diaphragmatic&#xD;
      excursion were well correlated with vital capacity by lung function testing and diaphragmatic&#xD;
      ultrasound imaging was demonstrated accurately to identify atrophy and impaired contractility&#xD;
      or motion of the diaphragm.The primary aim of this present study was to investigate&#xD;
      respiratory complications after OLV in the postoperative period by using bedside lung&#xD;
      ultrasonography.The secondary aim was to evaluate the variation of lung ventilation during&#xD;
      thoracoscopic surgery through lung ultrasonography combine with diaphragm ultrasound and&#xD;
      assess the accuracy of ultrasound to confirm proper endobronchial intubation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 10, 2019</start_date>
  <completion_date type="Anticipated">May 2019</completion_date>
  <primary_completion_date type="Anticipated">March 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of respiratory complications after one-lung ventiltion(OLV) in the postoperative period by using bedside lung ultrasonography</measure>
    <time_frame>15 minutes after tracheal extubation</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The variation of lung ventilation during thoracoscopic surgery through lung ultrasound combined with diaphragm ultrasound</measure>
    <time_frame>before induction, 5 minutes after intubation, 5 minutes after surgery,15 minutes after tracheal extubation</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Accuracy of Lung ultrasound in confirming proper endobronchial intubation</measure>
    <time_frame>5 minutes after one- lung ventilation</time_frame>
  </other_outcome>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Videoassisted Thoracoscopic Surgery,One-lung Ventilation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled for elective thoracoscopic surgery of OLV and over 18 years of age were&#xD;
        included in the present study if they screened for the inclusion criteria. Patients were&#xD;
        excluded if there were noncooperate from schizophrenia or delirium, a body mass index(BMI)&#xD;
        higher than 40 kg/m2, a history of respiratory infection, chronic obstructive pulmonary&#xD;
        disease(COPD), Chronic Heart Disease(CHD). Those received brachial plexus nerve block or&#xD;
        general anesthesia within 2 weeks before surgery were also excluded. Former thoracic&#xD;
        procedures (e.g.,thoracotomy, thoracoscopy or thoracic drain) were either criterions for&#xD;
        exclusion.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  scheduled for elective thoracoscopic surgery of OLV, over 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  noncooperate from schizophrenia or delirium, a BMI higher than 40 kg/m2, a history of&#xD;
             respiratory infection, a history of chronic obstructive pulmonary disease(COPD), a&#xD;
             history of Chronic Heart Disease(CHD), received brachial plexus nerve block or general&#xD;
             anesthesia within 2 weeks before surgery , received former thoracic procedures&#xD;
             (e.g.,thoracotomy, thoracoscopy or thoracic drain)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Min Yan, Doctor</last_name>
    <role>Study Chair</role>
    <affiliation>Zhejiang University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chen Xie, Master</last_name>
    <phone>13252017900</phone>
    <phone_ext>13252017900</phone_ext>
    <email>1228617258@qq.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>The second affiliated hospital of Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Min Yan, Doctor</last_name>
      <phone>13757118632</phone>
      <phone_ext>13252017900</phone_ext>
      <email>zryanmin@zju.edu.cn</email>
    </contact>
    <contact_backup>
      <last_name>Chen Xie</last_name>
      <phone>13252017900</phone>
      <phone_ext>13252017900</phone_ext>
      <email>1228617258@qq.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>February 18, 2019</last_update_submitted>
  <last_update_submitted_qc>February 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03802968
org study id: 2018-185
nct id: NCT03802968
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Perioperative lung-protective strategies had been advocated in one-lung ventilation but
      normal respiratory functions were yet impacted during videoassisted thoracoscopic(VATS)
      surgery. The primary aim of this study was to investigate respiratory complications after
      OLVby using bedside lung ultrasonography combine with diaphragmatic ultrasonography.
Perioperative lung-protective strategies had been advocated in One-lung Ventilation(OLV) of
      videoassisted thoracoscopic(VATS) surgery but normal respiratory functions were yet impacted
      during general anesthesia, mechanical ventilation, loss of respiratory muscle tone and
      intrathoracic surgery. Lung ultrasonography has been confirmed to be a available tool for
      rapid confirming atelectasis, pleural effusion , pneumonia and pneumothorax. Diaphragmatic
      excursion were well correlated with vital capacity by lung function testing and diaphragmatic
      ultrasound imaging was demonstrated accurately to identify atrophy and impaired contractility
      or motion of the diaphragm.The primary aim of this present study was to investigate
      respiratory complications after OLV in the postoperative period by using bedside lung
      ultrasonography.The secondary aim was to evaluate the variation of lung ventilation during
      thoracoscopic surgery through lung ultrasonography combine with diaphragm ultrasound and
      assess the accuracy of ultrasound to confirm proper endobronchial intubation.
observational model: Cohort
time perspective: Prospective
measure: Rate of respiratory complications after one-lung ventiltion(OLV) in the postoperative period by using bedside lung ultrasonography
time frame: 15 minutes after tracheal extubation
measure: The variation of lung ventilation during thoracoscopic surgery through lung ultrasound combined with diaphragm ultrasound
time frame: before induction, 5 minutes after intubation, 5 minutes after surgery,15 minutes after tracheal extubation
measure: Accuracy of Lung ultrasound in confirming proper endobronchial intubation
time frame: 5 minutes after one- lung ventilation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Min Yan, Doctor
role: Study Chair
affiliation: Zhejiang University
last name: Chen Xie, Master
phone: 13252017900
phone ext: 13252017900
email: 1228617258@qq.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
sharing ipd: No