<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/NCT02198625</url>
  </required_header>
  <id_info>
    <org_study_id>18826410080</org_study_id>
    <nct_id>NCT02198625</nct_id>
  </id_info>
  <brief_title>Influence of Moderate Inspired Oxygen Fraction (FiO2) and Protective Ventilation on Postoperative Pulmonary Complication</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fenmei Shi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Affiliated Hospital, Sun Yat-Sen University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the influence of moderate FiO2 and the lung&#xD;
      protective ventilation on postoperative pulmonary complications following hepatic resection&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>March 2014</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">June 2015</primary_completion_date>
  <phase>Phase 4</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>a composite of pulmonary and extrapulmonary complications occurring by day 7 after surgery.</measure>
    <time_frame>during the first seven days after surgery</time_frame>
    <description>The primary outcome was a composite of major pulmonary complications (defined as pneumonia or need for invasive or noninvasive ventilation for acute respiratory failure) and extrapulmonary complications (defined as sepsis, septic shock, or death) within the first 7 days after surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of pulmonary complications</measure>
    <time_frame>within the 30-day follow-up period</time_frame>
    <description>the incidence of pulmonary complications due to any cause, graded on a scale from 0 (no pulmonary complications) to 4 (the most severe complications);extrapulmonary complications; durations of ICU and hospital stays;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxidative stress markers</measure>
    <time_frame>2 days</time_frame>
    <description>Oxidative stress markers variation in blood before anesthesia,during and after surgery , and compare with controls.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">280</enrollment>
  <condition>Hepatectomy</condition>
  <arm_group>
    <arm_group_label>FiO2 80%,Nonprotective Lung Ventilation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>FiO2 30%,Nonprotective Lung Ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FiO2 30%,Nonprotective Lung Ventilation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FiO2 80%,protective Lung Ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FiO2 80% and protective Lung Ventilation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>FiO2 30%,protective Lung Ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FiO2 30% and protective Lung Ventilation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Moderate FiO2 and Protective Lung Ventilation Using</intervention_name>
    <arm_group_label>FiO2 30%,Nonprotective Lung Ventilation</arm_group_label>
    <arm_group_label>FiO2 30%,protective Lung Ventilation</arm_group_label>
    <arm_group_label>FiO2 80%,protective Lung Ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA 1~2,Planned intrabdominal hepatic resection surgery;&#xD;
&#xD;
          -  Expected duration 2 hours to 6 hours;&#xD;
&#xD;
          -  Age 40 yr to 70 yr);&#xD;
&#xD;
          -  BMI 18-26.9kg/m2&#xD;
&#xD;
          -  Risk of postoperative pulmonary complications (Arozullah score ≥2);&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Noninvasive ventilation in the last 30 days;&#xD;
&#xD;
          -  Recent history of pneumonia, ALI/ARDS (in the last 30 days);&#xD;
&#xD;
          -  History of pulmonary resection;&#xD;
&#xD;
          -  History of neuromuscular disease;&#xD;
&#xD;
          -  Child-Pugh&gt;A grade；&#xD;
&#xD;
          -  Patient refusal;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Fenmei Shi, M.M.</last_name>
    <email>shifenmei2006@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>First Affiliated Hospital, Sun Yat-Sen University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ying Xiao, MD,PhD</last_name>
      <email>xying2603@163.com</email>
    </contact>
    <investigator>
      <last_name>Ying Xiao, MD,PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 13, 2014</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <last_update_submitted>July 22, 2014</last_update_submitted>
  <last_update_submitted_qc>July 22, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>First Affiliated Hospital, Sun Yat-Sen University</investigator_affiliation>
    <investigator_full_name>Fenmei Shi</investigator_full_name>
    <investigator_title>resident</investigator_title>
  </responsible_party>
  <keyword>Moderate FiO2</keyword>
  <keyword>Protective lung ventilation</keyword>
  <keyword>Postoperative pulmonary complications</keyword>
  <keyword>Positive end-expiratory pressure</keyword>
  <keyword>recruitment maneuvers</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/NCT02198625
org study id: 18826410080
nct id: NCT02198625
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine the influence of moderate FiO2 and the lung
      protective ventilation on postoperative pulmonary complications following hepatic resection
      surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: a composite of pulmonary and extrapulmonary complications occurring by day 7 after surgery.
time frame: during the first seven days after surgery
description: The primary outcome was a composite of major pulmonary complications (defined as pneumonia or need for invasive or noninvasive ventilation for acute respiratory failure) and extrapulmonary complications (defined as sepsis, septic shock, or death) within the first 7 days after surgery.
measure: incidence of pulmonary complications
time frame: within the 30-day follow-up period
description: the incidence of pulmonary complications due to any cause, graded on a scale from 0 (no pulmonary complications) to 4 (the most severe complications);extrapulmonary complications; durations of ICU and hospital stays;
measure: Oxidative stress markers
time frame: 2 days
description: Oxidative stress markers variation in blood before anesthesia,during and after surgery , and compare with controls.
arm group label: FiO2 80%,Nonprotective Lung Ventilation
arm group type: No Intervention
arm group label: FiO2 30%,Nonprotective Lung Ventilation
arm group type: Experimental
description: FiO2 30%,Nonprotective Lung Ventilation
arm group label: FiO2 80%,protective Lung Ventilation
arm group type: Experimental
description: FiO2 80% and protective Lung Ventilation
arm group label: FiO2 30%,protective Lung Ventilation
arm group type: Experimental
description: FiO2 30% and protective Lung Ventilation
intervention type: Other
intervention name: Moderate FiO2 and Protective Lung Ventilation Using
arm group label: FiO2 30%,Nonprotective Lung Ventilation
arm group label: FiO2 30%,protective Lung Ventilation
arm group label: FiO2 80%,protective Lung Ventilation
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Fenmei Shi, M.M.
email: shifenmei2006@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: First Affiliated Hospital, Sun Yat-Sen University
investigator full name: Fenmei Shi
investigator title: resident