<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/NCT03282032</url>
  </required_header>
  <id_info>
    <org_study_id>JHSeo_preconditioning</org_study_id>
    <nct_id>NCT03282032</nct_id>
  </id_info>
  <brief_title>Preconditioning of One-lung Ventilation</brief_title>
  <official_title>Preconditioning of One-lung Ventilation for Lung Protection</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>No</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 effect of one-lung ventilation (OLV) preconditioning on perioperative&#xD;
      oxygenation during thoracic surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      For lung isolation and better surgical view, one-lung ventilation(OLV) is essential for&#xD;
      thoracic surgery. However, OLV may cause serious pulmonary complications due to&#xD;
      intraoperative hypoxia.&#xD;
&#xD;
      Animal studies showed a positive effect of OLV preconditioning (Intermittent OLV before&#xD;
      surgical intervention) on perioperative pulmonary oxygenation.&#xD;
&#xD;
      Thus, we designed a study to observe the effect of OLV preconditioning on perioperative&#xD;
      oxygenation during thoracic surgery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 22, 2017</start_date>
  <completion_date type="Actual">October 13, 2018</completion_date>
  <primary_completion_date type="Actual">October 9, 2018</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 hypoxemia</measure>
    <time_frame>during one-lung ventilation, up to 5 hours</time_frame>
    <description>SpO2 &lt; 95%</description>
  </primary_outcome>
  <primary_outcome>
    <measure>P/F ratio</measure>
    <time_frame>30min after surgical incision</time_frame>
    <description>PaO2/FIO2 ratio</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pulmonary complications</measure>
    <time_frame>6, 24, 48 hours after surgery, during hospital stay.</time_frame>
    <description>Acute lung injury, acute respiratory distress syndrome, atelectasis, pneumonia</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">136</enrollment>
  <condition>One Lung Ventilation</condition>
  <arm_group>
    <arm_group_label>One-lung ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Before surgical incision, 2-min of OLV followed by 2-min of TLV (1 cycle) is performed for 5 cycles.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Two-lung ventilation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Maintain two-lung ventilation until surgical incision</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>One-lung ventilation</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, 5 cycles of one-lung ventilation preconditioning (2-min of one-lung ventilation and 2-min of two-lung ventilation for 1 cycle) is performed before surgical incision. One-lung ventilation is done at dependent lung with FiO2 100% and tidal volume 6 ml kg-1. Two-lung ventilation is done with FiO2 50%, tidal volume 8 ml kg-1.</description>
    <arm_group_label>One-lung ventilation</arm_group_label>
    <other_name>Preconditioning</other_name>
  </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 with severe cardiopulmonary disease, COPD, previous surgical history of&#xD;
             pulmonary disease&#xD;
&#xD;
          -  Thoracic surgery for pneumonectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 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>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Benumof JL. Intermittent hypoxia increases lobar hypoxic pulmonary vasoconstriction. Anesthesiology. 1983 May;58(5):399-404. doi: 10.1097/00000542-198305000-00001.</citation>
    <PMID>6837992</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>November 28, 2018</last_update_submitted>
  <last_update_submitted_qc>November 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 30, 2018</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>
  <!-- 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/NCT03282032
org study id: JHSeo_preconditioning
nct id: NCT03282032
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To observe the effect of one-lung ventilation (OLV) preconditioning on perioperative
      oxygenation during thoracic surgery.
For lung isolation and better surgical view, one-lung ventilation(OLV) is essential for
      thoracic surgery. However, OLV may cause serious pulmonary complications due to
      intraoperative hypoxia.

      Animal studies showed a positive effect of OLV preconditioning (Intermittent OLV before
      surgical intervention) on perioperative pulmonary oxygenation.

      Thus, we designed a study to observe the effect of OLV preconditioning on perioperative
      oxygenation during thoracic surgery
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Incidence of hypoxemia
time frame: during one-lung ventilation, up to 5 hours
description: SpO2 < 95%
measure: P/F ratio
time frame: 30min after surgical incision
description: PaO2/FIO2 ratio
measure: Pulmonary complications
time frame: 6, 24, 48 hours after surgery, during hospital stay.
description: Acute lung injury, acute respiratory distress syndrome, atelectasis, pneumonia
arm group label: One-lung ventilation
arm group type: Experimental
description: Before surgical incision, 2-min of OLV followed by 2-min of TLV (1 cycle) is performed for 5 cycles.
arm group label: Two-lung ventilation
arm group type: No Intervention
description: Maintain two-lung ventilation until surgical incision
intervention type: Other
intervention name: One-lung ventilation
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, 5 cycles of one-lung ventilation preconditioning (2-min of one-lung ventilation and 2-min of two-lung ventilation for 1 cycle) is performed before surgical incision. One-lung ventilation is done at dependent lung with FiO2 100% and tidal volume 6 ml kg-1. Two-lung ventilation is done with FiO2 50%, tidal volume 8 ml kg-1.
arm group label: One-lung ventilation
other name: Preconditioning
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jeong-Hwa Seo, PhD
role: Study Chair
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
citation: Benumof JL. Intermittent hypoxia increases lobar hypoxic pulmonary vasoconstriction. Anesthesiology. 1983 May;58(5):399-404. doi: 10.1097/00000542-198305000-00001.
PMID: 6837992
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jeong-Hwa Seo
investigator title: Professor