<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/NCT03802175</url>
  </required_header>
  <id_info>
    <org_study_id>2018-177</org_study_id>
    <nct_id>NCT03802175</nct_id>
  </id_info>
  <brief_title>The Application Of Lung Ultrasound In Postoperative Hypoxemia Patients</brief_title>
  <official_title>The Application Of Lung Ultrasound About Pulmonary Complications In Postoperative Hypoxemia Patients After General Anesthesia：A Prospective Observational Study</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>
      Postoperative hypoxemia was persistent and common after surgery.Rapid diagnosis and&#xD;
      subsequent therapeutic measures must be adopted by anesthesiologists.Lung ultrasound has been&#xD;
      confirmed to be more sensitive and accurate for diagnosis of pulmonary ailment than chest&#xD;
      radiography.The primary objective of the present study was to evaluate lung complications by&#xD;
      bedside lung ultrasonography on patients suffered from hypoxemia after general anesthesia in&#xD;
      the postoperative period.&#xD;
    </textblock>
  </brief_summary>
  <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">August 2019</completion_date>
  <primary_completion_date type="Anticipated">June 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>8 Months</target_duration>
  <primary_outcome>
    <measure>Pulmonary Complications of Lung Ultrasound</measure>
    <time_frame>20 minutes after tracheal extubation</time_frame>
    <description>Pulmonary disease including atelectasis, pneumonia, pneumothorax and pleural effusion would be discovered by lung ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of Lung Ultrasound and Computed Tomography(CT)</measure>
    <time_frame>Within 1 hour after examnation of Lung Ultrasound</time_frame>
    <description>Lung ultrasound offers high sensitivity and specificity when compared with CT</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Correlative Factors of Lung Ultrasound Score</measure>
    <time_frame>Through study completion, up to 8 months</time_frame>
    <description>Higher score value represent more ventilation loss</description>
  </other_outcome>
  <enrollment type="Anticipated">113</enrollment>
  <condition>Hypoxemia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Parients in postoperative care unit(PACU) of 18 years at least and suffering from hypoxemia&#xD;
        after general anesthesia and noncardiac surgeries were included in our study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - at least 18 years of age, hypoxemia after general anesthesia ( definded as a SPO2&#xD;
        &lt;92%,greater than 30s)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Covered with surgical dressings from opening thoracic and breast surgery, noncooperate&#xD;
             from schizophrenia or delirium, a BMI higher than 40 kg/m2, unstable hemodynamics,&#xD;
             dyspnea from residual opioids or muscle relaxants, hemoglobin of 8g/L or less, risk of&#xD;
             bleeding, body temperature was more than 38℃ or less than 36℃&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 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>
    <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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypoxia</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/NCT03802175
org study id: 2018-177
nct id: NCT03802175
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Postoperative hypoxemia was persistent and common after surgery.Rapid diagnosis and
      subsequent therapeutic measures must be adopted by anesthesiologists.Lung ultrasound has been
      confirmed to be more sensitive and accurate for diagnosis of pulmonary ailment than chest
      radiography.The primary objective of the present study was to evaluate lung complications by
      bedside lung ultrasonography on patients suffered from hypoxemia after general anesthesia in
      the postoperative period.
observational model: Cohort
time perspective: Prospective
measure: Pulmonary Complications of Lung Ultrasound
time frame: 20 minutes after tracheal extubation
description: Pulmonary disease including atelectasis, pneumonia, pneumothorax and pleural effusion would be discovered by lung ultrasound
measure: Comparison of Lung Ultrasound and Computed Tomography(CT)
time frame: Within 1 hour after examnation of Lung Ultrasound
description: Lung ultrasound offers high sensitivity and specificity when compared with CT
measure: Correlative Factors of Lung Ultrasound Score
time frame: Through study completion, up to 8 months
description: Higher score value represent more ventilation loss
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Min Yan, Doctor
role: Study Chair
affiliation: Zhejiang University
last name: Chen Xie, Master
phone: 13252017900
email: 1228617258@qq.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor
mesh term: Hypoxia
sharing ipd: No