xml: <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/NCT06013098</url>
    </required_header>
    <id_info>
      <org_study_id>20230724-2</org_study_id>
      <nct_id>NCT06013098</nct_id>
    </id_info>
    <brief_title>Effects of Different Oxygen Concentrations on Pulmonary Complications in Patients Undergoing Radical Resection of Esophageal Cancer</brief_title>
    <acronym>DOICA-E</acronym>
    <official_title>Effects of Different Oxygen Concentrations on Pulmonary Complications in Patients Undergoing Radical Resection of Esophageal Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>China Medical University, China</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>China Medical University, China</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>
        Radical operation of esophageal cancer is complicated and traumatic, and ventilation with one&#xD;
        lung in lateral position and ventilation with both lungs after supine position requires&#xD;
        long-term tracheal intubation and ventilator-assisted ventilation, and the incidence of&#xD;
        postoperative pulmonary complications is high.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Therefore, we should explore the most appropriate lung protection ventilation strategy to&#xD;
        reduce the occurrence of pulmonary complications. The recommended standard of international&#xD;
        expert group on lung protective ventilation strategy points out that the lowest concentration&#xD;
        of oxygen (≤40%) should be inhaled as much as possible during mechanical ventilation to&#xD;
        maintain normal blood oxygen level (SpO2≥94%). If the mixed gas with low inhaled oxygen&#xD;
        concentration can achieve ideal oxygen saturation and arterial oxygen partial pressure, it&#xD;
        may reduce the postoperative pulmonary complications of the subjects. However, there are few&#xD;
        reports on the influence of different oxygen concentrations on pulmonary complications in&#xD;
        patients undergoing radical resection of esophageal cancer. This study intends to explore the&#xD;
        influence of different oxygen concentrations on pulmonary complications in patients&#xD;
        undergoing radical resection of esophageal cancer.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2026</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2025</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>the occurrence of atelectasis</measure>
      <time_frame>On the operating room within 40 minutes after awakening</time_frame>
      <description>The primary outcome is the occurrence of atelectasis scanned by computerized tomography in the operating room within 40 minutes after awakening</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>oxygenation index</measure>
      <time_frame>On the operating room within 40 minutes after awakening</time_frame>
      <description>The secondary outcome is the comparison of the oxygenation index between the two groups, which is calculated and compared from the results of intraoperative blood gas analysis</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Atelectasis, Postoperative</condition>
    <arm_group>
      <arm_group_label>Experimental: 30% Oxygen</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Before anesthesia induction, the participants inhaled pure oxygen through the mask for 5 minuets. After successful anesthesia induction, FiO2 will be adjusted to 60% in one lung ventilation and 30% FIO2 in both lungs ventilation, and the total gas flow rate will be set at 2L/min. All patients will be performed via the lung protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cm H2O, RR: 1:2. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation, however when intraoperative oxygen saturation is less than 92% the manual lung recruitment maneuver will be done too. Arterial blood will be collected for blood gas analysis. Patients in both groups will be extubation the operating room and then sent to the PACU. patients should transfer to 60% Oxygen group if intraoperative oxygen saturation less than 85%.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Experimental: 60% Oxygen</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Before anesthesia induction, the participants inhaled pure oxygen through the mask for 5 minutes. After successful anesthesia induction, FiO2 will be adjusted to 100% in one lung ventilation and 60% FIO2 in both lungs ventilation, and the total gas flow rate will be set at 2L/min. All patients will be performed via the lung protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cm H2O, RR: 1:2. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation, however when intraoperative oxygen saturation is less than 92% the manual lung recruitment maneuver will be done too. Arterial blood will be collected for blood gas analysis. Patients in both groups will be extubation the operating room and then sent to the PACU.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>30%Oxygen</intervention_name>
      <description>60%FiO2 in one lung ventilation and 30% FIO2 in both lungs ventilation</description>
      <arm_group_label>Experimental: 30% Oxygen</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>60%Oxygen</intervention_name>
      <description>100%FiO2 in one lung ventilation and 60% FIO2 in both lungs ventilation</description>
      <arm_group_label>Experimental: 60% Oxygen</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  American Association of Anesthesiologists (ASA) patients with I-II physical condition;&#xD;
  &#xD;
            -  Patients with preoperative partial pressure of blood gas and oxygen greater than&#xD;
               80mmHg who were scheduled for elective esophageal cancer surgery were operated in the&#xD;
               right lateral position first and then in the supine position.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  there is a history of acute lung injury with acute respiratory distress syndrome&#xD;
               within three months;&#xD;
  &#xD;
            -  Heart failure (classified by new york Heart Association) is greater than grade IV,&#xD;
  &#xD;
            -  there is a serious liver and kidney dysfunction (children with grade B or C liver&#xD;
               failure, glomerular filtration rate &lt; 30 ml/min);&#xD;
  &#xD;
            -  Body mass index &gt; 30kg/m2；&#xD;
  &#xD;
            -  coagulation dysfunction;&#xD;
  &#xD;
            -  Patients receiving neoadjuvant chemotherapy;&#xD;
  &#xD;
            -  Operation time exceeds 10h&#xD;
  &#xD;
            -  The amount of bleeding is more than 800ml, and the total fluid volume is more than&#xD;
               3000ml.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>the First Hospital of China Medical University</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <zip>110001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wenfei Tan, M.D.,Ph.D</last_name>
        <phone>024-83283100</phone>
        <email>winfieldtan@hotmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>China Medical University, China</investigator_affiliation>
      <investigator_full_name>Wenfei Tan</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Esophageal Neoplasms</mesh_term>
      <mesh_term>Pulmonary Atelectasis</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06013098
  org study id: 20230724-2
  nct id: NCT06013098
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Radical operation of esophageal cancer is complicated and traumatic, and ventilation with one
        lung in lateral position and ventilation with both lungs after supine position requires
        long-term tracheal intubation and ventilator-assisted ventilation, and the incidence of
        postoperative pulmonary complications is high.
  Therefore, we should explore the most appropriate lung protection ventilation strategy to
        reduce the occurrence of pulmonary complications. The recommended standard of international
        expert group on lung protective ventilation strategy points out that the lowest concentration
        of oxygen (≤40%) should be inhaled as much as possible during mechanical ventilation to
        maintain normal blood oxygen level (SpO2≥94%). If the mixed gas with low inhaled oxygen
        concentration can achieve ideal oxygen saturation and arterial oxygen partial pressure, it
        may reduce the postoperative pulmonary complications of the subjects. However, there are few
        reports on the influence of different oxygen concentrations on pulmonary complications in
        patients undergoing radical resection of esophageal cancer. This study intends to explore the
        influence of different oxygen concentrations on pulmonary complications in patients
        undergoing radical resection of esophageal cancer.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: the occurrence of atelectasis
  time frame: On the operating room within 40 minutes after awakening
  description: The primary outcome is the occurrence of atelectasis scanned by computerized tomography in the operating room within 40 minutes after awakening
  measure: oxygenation index
  time frame: On the operating room within 40 minutes after awakening
  description: The secondary outcome is the comparison of the oxygenation index between the two groups, which is calculated and compared from the results of intraoperative blood gas analysis
  arm group label: Experimental: 30% Oxygen
  arm group type: Experimental
  description: Before anesthesia induction, the participants inhaled pure oxygen through the mask for 5 minuets. After successful anesthesia induction, FiO2 will be adjusted to 60% in one lung ventilation and 30% FIO2 in both lungs ventilation, and the total gas flow rate will be set at 2L/min. All patients will be performed via the lung protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cm H2O, RR: 1:2. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation, however when intraoperative oxygen saturation is less than 92% the manual lung recruitment maneuver will be done too. Arterial blood will be collected for blood gas analysis. Patients in both groups will be extubation the operating room and then sent to the PACU. patients should transfer to 60% Oxygen group if intraoperative oxygen saturation less than 85%.
  arm group label: Experimental: 60% Oxygen
  arm group type: Placebo Comparator
  description: Before anesthesia induction, the participants inhaled pure oxygen through the mask for 5 minutes. After successful anesthesia induction, FiO2 will be adjusted to 100% in one lung ventilation and 60% FIO2 in both lungs ventilation, and the total gas flow rate will be set at 2L/min. All patients will be performed via the lung protective ventilation strategy. The respiratory parameters are VT: 6-8ml/kg, PEEP: 6-8 cm H2O, RR: 1:2. Manual lung recruitment maneuvers will be performed after tracheal intubation and before tracheal extubation, however when intraoperative oxygen saturation is less than 92% the manual lung recruitment maneuver will be done too. Arterial blood will be collected for blood gas analysis. Patients in both groups will be extubation the operating room and then sent to the PACU.
  intervention type: Drug
  intervention name: 30%Oxygen
  description: 60%FiO2 in one lung ventilation and 30% FIO2 in both lungs ventilation
  arm group label: Experimental: 30% Oxygen
  intervention type: Drug
  intervention name: 60%Oxygen
  description: 100%FiO2 in one lung ventilation and 60% FIO2 in both lungs ventilation
  arm group label: Experimental: 60% Oxygen
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: China Medical University, China
  investigator full name: Wenfei Tan
  investigator title: Professor
  mesh term: Esophageal Neoplasms
  mesh term: Pulmonary Atelectasis
  sharing ipd: Undecided