<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/NCT03770793</url>
  </required_header>
  <id_info>
    <org_study_id>JHSeo_LungSono</org_study_id>
    <nct_id>NCT03770793</nct_id>
  </id_info>
  <brief_title>Effectiveness of Lung Sono in One-lung Ventilation</brief_title>
  <official_title>Effectiveness of Ultrasound-guided Alveolar Recruitment in Thoracic Surgery With One-lung Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</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>
      To observe the effectiveness of ultrasound-guided alveolar recruitment in thoracic surgery&#xD;
      with one-lung ventilation(OLV).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One-lung ventilation(OLV) is essential in thoracic surgery for patient safety and better&#xD;
      surgical view. However, pulmonary complications such as hypoxemia may be caused by OLV which&#xD;
      might be preventable with adequate alveolar recruitment and positive end-expiratory&#xD;
      pressure(PEEP). Alveolar recruitment has been performed with conventional methods without&#xD;
      diagnostic tools in clinical setting.&#xD;
&#xD;
      Ultrasound is a non-invasive, radiation-free device with high accuracy for the diagnosis of&#xD;
      lung atelectasis. There are a few reports regarding the usefulness of lung ultrasound in&#xD;
      other surgeries, but not in thoracic surgeries with OLV.&#xD;
&#xD;
      Thus, investigators designed a study to observe the effectiveness of ultrasound-guided&#xD;
      alveolar recruitment in thoracic surgery with OLV.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2018</start_date>
  <completion_date type="Actual">May 7, 2019</completion_date>
  <primary_completion_date type="Actual">May 7, 2019</primary_completion_date>
  <phase>N/A</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of desaturation</measure>
    <time_frame>intraoperative</time_frame>
    <description>SpO2&lt;95%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>P/F ratio</measure>
    <time_frame>30 minutes after one-lung ventilation</time_frame>
    <description>PaO2/FiO2 ratio</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Lung ultrasound score</measure>
    <time_frame>just after anesthesia induction, end of surgery</time_frame>
    <description>Lung ultrasound score of atelectasis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alveolar dead space</measure>
    <time_frame>30 minutes after one-lung ventilation</time_frame>
    <description>(PaCO2-PetCO2)xVt/PaCO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary complications</measure>
    <time_frame>intraoperative, during hospital stay(an average of 3 days)</time_frame>
    <description>respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, atelectasis, bronchospasm, aspiration pneumonitis</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">166</enrollment>
  <condition>One Lung Ventilation</condition>
  <arm_group>
    <arm_group_label>Lung-sono guided</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Before starting one-lung ventilation, alveolar recruitment is performed under the examination with ultrasound. Find the minimal airway pressure that actually starts to resolve the observed atelectasis. Repeat alveolar recruitment with the minimal pressure untill the atlelectasis is not visible.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Before starting one-lung ventilation, alveolar recruitment is performed with the pressure of 30mmHg for 10 seconds which is a conventional method.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lung-sono guided</intervention_name>
    <description>The patient undergoing thoracic surgery is intubated with double lumen tube after induction of general anesthesia with propofol and remifentanil.&#xD;
In the intervention group, alveolar recruitment is performed to the non-surgical side of lung under examination with ultrasound just after anesthesia induction.&#xD;
During the gradual increment in the pressure of recruitment, the anesthesiologist can find the opening pressure that means the minimal pressure at which observed atelectasis starts to disappear.&#xD;
Then, alveolar recruitment is performed with the opening pressure until the atelectasis is not visible.</description>
    <arm_group_label>Lung-sono guided</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective thoracic surgery which requires one-lung ventilation with lateral decubitus&#xD;
             position&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who refuse to agree&#xD;
&#xD;
          -  Previous lung surgical history&#xD;
&#xD;
          -  History of pneumothorax or bullae&#xD;
&#xD;
          -  Severe cardiopulmonary disease, COPD&#xD;
&#xD;
          -  Operation time &lt; 1hr&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jeong-Hwa Seo, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Song IK, Kim EH, Lee JH, Kang P, Kim HS, Kim JT. Utility of Perioperative Lung Ultrasound in Pediatric Cardiac Surgery: A Randomized Controlled Trial. Anesthesiology. 2018 Apr;128(4):718-727. doi: 10.1097/ALN.0000000000002069.</citation>
    <PMID>29309282</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>November 9, 2020</last_update_submitted>
  <last_update_submitted_qc>November 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jeong-Hwa Seo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>One lung ventilation</keyword>
  <keyword>Lung ultrasound</keyword>
  <keyword>Alveolar recruitment</keyword>
  <!-- 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/NCT03770793
org study id: JHSeo_LungSono
nct id: NCT03770793
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To observe the effectiveness of ultrasound-guided alveolar recruitment in thoracic surgery
      with one-lung ventilation(OLV).
One-lung ventilation(OLV) is essential in thoracic surgery for patient safety and better
      surgical view. However, pulmonary complications such as hypoxemia may be caused by OLV which
      might be preventable with adequate alveolar recruitment and positive end-expiratory
      pressure(PEEP). Alveolar recruitment has been performed with conventional methods without
      diagnostic tools in clinical setting.

      Ultrasound is a non-invasive, radiation-free device with high accuracy for the diagnosis of
      lung atelectasis. There are a few reports regarding the usefulness of lung ultrasound in
      other surgeries, but not in thoracic surgeries with OLV.

      Thus, investigators designed a study to observe the effectiveness of ultrasound-guided
      alveolar recruitment in thoracic surgery with OLV.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Incidence of desaturation
time frame: intraoperative
description: SpO2<95%
measure: P/F ratio
time frame: 30 minutes after one-lung ventilation
description: PaO2/FiO2 ratio
measure: Lung ultrasound score
time frame: just after anesthesia induction, end of surgery
description: Lung ultrasound score of atelectasis
measure: Alveolar dead space
time frame: 30 minutes after one-lung ventilation
description: (PaCO2-PetCO2)xVt/PaCO2
measure: Pulmonary complications
time frame: intraoperative, during hospital stay(an average of 3 days)
description: respiratory infection, respiratory failure, pleural effusion, atelectasis, pneumothorax, atelectasis, bronchospasm, aspiration pneumonitis
arm group label: Lung-sono guided
arm group type: Experimental
description: Before starting one-lung ventilation, alveolar recruitment is performed under the examination with ultrasound. Find the minimal airway pressure that actually starts to resolve the observed atelectasis. Repeat alveolar recruitment with the minimal pressure untill the atlelectasis is not visible.
arm group label: Conventional
arm group type: No Intervention
description: Before starting one-lung ventilation, alveolar recruitment is performed with the pressure of 30mmHg for 10 seconds which is a conventional method.
intervention type: Procedure
intervention name: Lung-sono guided
description: The patient undergoing thoracic surgery is intubated with double lumen tube after induction of general anesthesia with propofol and remifentanil.
In the intervention group, alveolar recruitment is performed to the non-surgical side of lung under examination with ultrasound just after anesthesia induction.
During the gradual increment in the pressure of recruitment, the anesthesiologist can find the opening pressure that means the minimal pressure at which observed atelectasis starts to disappear.
Then, alveolar recruitment is performed with the opening pressure until the atelectasis is not visible.
arm group label: Lung-sono guided
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jeong-Hwa Seo, PhD
role: Study Chair
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
citation: Song IK, Kim EH, Lee JH, Kang P, Kim HS, Kim JT. Utility of Perioperative Lung Ultrasound in Pediatric Cardiac Surgery: A Randomized Controlled Trial. Anesthesiology. 2018 Apr;128(4):718-727. doi: 10.1097/ALN.0000000000002069.
PMID: 29309282
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jeong-Hwa Seo
investigator title: Professor