<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/NCT03234621</url>
  </required_header>
  <id_info>
    <org_study_id>JHBahk_PV</org_study_id>
    <nct_id>NCT03234621</nct_id>
  </id_info>
  <brief_title>Protective Ventilation Strategy</brief_title>
  <official_title>Protective Ventilation Strategy During One-lung Ventilation: Effect on Postoperative Pulmonary Complications</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find a proper ventilation strategy for one-lung ventilation&#xD;
      to prevent postoperative pulmonary complications&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 12, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">October 12, 2017</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative pulmonary complications</measure>
    <time_frame>immediately after operation</time_frame>
    <description>PaO2/FiO2 and/or newly appeared atelectasis, lung infiltration</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">87</enrollment>
  <condition>One-lung Ventilation</condition>
  <arm_group>
    <arm_group_label>conventional tidal group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>provide tidal volume of 6ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>low tidal group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>provide tidal volume of 4ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high tidal group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>provide tidal volume of 8ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ventilator setting during one-lung ventilation</intervention_name>
    <description>providing various tidal volumes according to the groups with constant PEEP</description>
    <arm_group_label>conventional tidal group</arm_group_label>
    <arm_group_label>high tidal group</arm_group_label>
    <arm_group_label>low tidal group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing elective thoracic surgery&#xD;
&#xD;
          -  ASA I, II, III&#xD;
&#xD;
          -  scheduled &gt; 2 hours of surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  denied patients&#xD;
&#xD;
          -  age under 18 years&#xD;
&#xD;
          -  FEV1/FVC or FEV1&lt;70% in preoperative pulmonary function test&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jae Hyon Bahk, MD PhD</last_name>
      <phone>82-2-2072-2818</phone>
      <email>bahkjh@snu.ac.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>July 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>July 26, 2017</last_update_submitted>
  <last_update_submitted_qc>July 26, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jae-Hyon Bahk, MD, PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>protective ventilation strategy</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/NCT03234621
org study id: JHBahk_PV
nct id: NCT03234621
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to find a proper ventilation strategy for one-lung ventilation
      to prevent postoperative pulmonary complications
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: postoperative pulmonary complications
time frame: immediately after operation
description: PaO2/FiO2 and/or newly appeared atelectasis, lung infiltration
arm group label: conventional tidal group
arm group type: Experimental
description: provide tidal volume of 6ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation
arm group label: low tidal group
arm group type: Experimental
description: provide tidal volume of 4ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation
arm group label: high tidal group
arm group type: Experimental
description: provide tidal volume of 8ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation
intervention type: Other
intervention name: ventilator setting during one-lung ventilation
description: providing various tidal volumes according to the groups with constant PEEP
arm group label: conventional tidal group
arm group label: high tidal group
arm group label: low tidal group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jae-Hyon Bahk, MD, PhD
investigator title: Professor