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/NCT05982639</url>
    </required_header>
    <id_info>
      <org_study_id>Lung inflammation trial</org_study_id>
      <nct_id>NCT05982639</nct_id>
    </id_info>
    <brief_title>Comparative Analysis of the Lung Inflammatory Response After Thoracic Surgery With Single or Double Lung Ventilation: a Randomized, Pilot, Trial</brief_title>
    <official_title>Comparative Analysis of the Lung Inflammatory Response After Thoracic Surgery With Single or Double Lung Ventilation: a Randomized, Pilot, Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude</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>
        The goal of this clinical trial is to compare in patients undergoing thoracic procedures the&#xD;
        lung inflammatory response in on one-lung ventilation and two-lung ventilation strategies The&#xD;
        main question to answer is:&#xD;
  &#xD;
        • Lung inflammation differs when comparing one to two-lung ventilation strategies during the&#xD;
        procedure? Participants will be divided in the classic one lung ventilation or two lung&#xD;
        ventilation (using pneumothorax with CO2) and different biomarkers of lung inflammation will&#xD;
        be measured after procedures.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 20, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">December 1, 2023</primary_completion_date>
    <phase>Phase 2</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>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Bronchoalveolar lavage fluid (BALF) levels of IL-6</measure>
      <time_frame>at a maximum 2 hours after the end of the thoracic procedure</time_frame>
      <description>It will be compared the levels of IL-6 in the BALF collected immediately before and after the thoracic procedure</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Bronchoalveolar lavage fluid (BALF) levels of IL-8</measure>
      <time_frame>at a maximum 2 hours after the end of the thoracic procedure</time_frame>
      <description>It will be compared the levels of IL-8 in the BALF collected immediately before and after the thoracic procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bronchoalveolar lavage fluid (BALF) levels of IL-1</measure>
      <time_frame>at a maximum 2 hours after the end of the thoracic procedure</time_frame>
      <description>It will be compared the levels of IL-1 in the BALF collected immediately before and after the thoracic procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bronchoalveolar lavage fluid (BALF) levels of TNF</measure>
      <time_frame>at a maximum 2 hours after the end of the thoracic procedure</time_frame>
      <description>It will be compared the levels of TNF in the BALF collected immediately before and after the thoracic procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bronchoalveolar lavage fluid (BALF) levels of oxidative stress</measure>
      <time_frame>at a maximum 2 hours after the end of the thoracic procedure</time_frame>
      <description>It will be compared the levels of malondialdehyde equivalents in the BALF collected immediately before and after the thoracic procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-procedure pulmonary complications</measure>
      <time_frame>Until hospital discharge</time_frame>
      <description>Composite outcome of associated pulmonary complications including pneumonia, re-expansion edema and postoperative non-re-expansion of the lung</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Systemic levels of inflammatory and oxidative markers</measure>
      <time_frame>at a maximum 2 hours after the end of the thoracic procedure</time_frame>
      <description>Plasma levels of IL-6, IL-8, IL-1, TNF and malondialdehyde equivalents</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Thoracic Diseases</condition>
    <condition>Surgery</condition>
    <arm_group>
      <arm_group_label>one-lung ventilation</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Usual care. One lung ventilation will be provided using a Carleans type double lumen orotracheal tube.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>two-lung ventilation and use of pneumothorax with CO2.</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Two lung ventilation will be provided using a single lumen orotracheal tube and CO2-induced pneumothorax</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>two lung ventilation</intervention_name>
      <description>The intervention do not involve a drug or device. It will be compared two different approaches to ventilate the lungs during the procedure . In this arm both lungs will be ventilated inserting a disposable trocar into the pleural cavity, and insufflating CO2 into the thoracic cavity via an insufflator. The insufflation pressure and the flow rate will be set as 8 mmHg and 10 l.min-1, of the cavity with CO2. The insufflator will be adjusted for cavity pressure in 8mmHg and flow of 10L/min.</description>
      <arm_group_label>two-lung ventilation and use of pneumothorax with CO2.</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>one lung ventilation</intervention_name>
      <description>In this arm only one lung (the contralateral lung) will be ventilated using a Carlens type orotracheal tube</description>
      <arm_group_label>one-lung ventilation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  A diagnosis of pleural or mediastinal pathology that requires diagnostic or&#xD;
               therapeutic surgical intervention;&#xD;
  &#xD;
            -  Written consent to participate&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women;&#xD;
  &#xD;
            -  Patients on mechanical ventilation prior to the procedure;&#xD;
  &#xD;
            -  Patients classified by the American Society of Anesthesiology (ASA) as class 4;&#xD;
  &#xD;
            -  Patients with subpulmonary or diaphragmatic pathologies, where it is believed that the&#xD;
               two pulmonary technique is superior;&#xD;
  &#xD;
            -  Impossibility of using a double-lumen tube or difficult intubation;&#xD;
  &#xD;
            -  Patient does not support one-lung ventilation;&#xD;
  &#xD;
            -  Patient with previous lung resection surgery&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Eduardo Balleter, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Felipe Dal Pizzol, MD, PhD</last_name>
      <phone>+5548991852300</phone>
      <email>fdpizzol@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hospital Azambuja</name>
        <address>
          <city>Brusque</city>
          <state>Santa Catarina</state>
          <zip>88353-902</zip>
          <country>Brazil</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Eugenio Jose P Maciel, MD</last_name>
        <phone>+55473396-2200</phone>
        <email>sac@haccr.org.br</email>
      </contact>
    </location>
    <location_countries>
      <country>Brazil</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>August 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 5, 2023</last_update_submitted>
    <last_update_submitted_qc>August 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude</investigator_affiliation>
      <investigator_full_name>Felipe Dal Pizzol</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>Thoracic Diseases</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/NCT05982639
  org study id: Lung inflammation trial
  nct id: NCT05982639
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to compare in patients undergoing thoracic procedures the
        lung inflammatory response in on one-lung ventilation and two-lung ventilation strategies The
        main question to answer is:
  
        • Lung inflammation differs when comparing one to two-lung ventilation strategies during the
        procedure? Participants will be divided in the classic one lung ventilation or two lung
        ventilation (using pneumothorax with CO2) and different biomarkers of lung inflammation will
        be measured after procedures.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  measure: Bronchoalveolar lavage fluid (BALF) levels of IL-6
  time frame: at a maximum 2 hours after the end of the thoracic procedure
  description: It will be compared the levels of IL-6 in the BALF collected immediately before and after the thoracic procedure
  measure: Bronchoalveolar lavage fluid (BALF) levels of IL-8
  time frame: at a maximum 2 hours after the end of the thoracic procedure
  description: It will be compared the levels of IL-8 in the BALF collected immediately before and after the thoracic procedure
  measure: Bronchoalveolar lavage fluid (BALF) levels of IL-1
  time frame: at a maximum 2 hours after the end of the thoracic procedure
  description: It will be compared the levels of IL-1 in the BALF collected immediately before and after the thoracic procedure
  measure: Bronchoalveolar lavage fluid (BALF) levels of TNF
  time frame: at a maximum 2 hours after the end of the thoracic procedure
  description: It will be compared the levels of TNF in the BALF collected immediately before and after the thoracic procedure
  measure: Bronchoalveolar lavage fluid (BALF) levels of oxidative stress
  time frame: at a maximum 2 hours after the end of the thoracic procedure
  description: It will be compared the levels of malondialdehyde equivalents in the BALF collected immediately before and after the thoracic procedure
  measure: Post-procedure pulmonary complications
  time frame: Until hospital discharge
  description: Composite outcome of associated pulmonary complications including pneumonia, re-expansion edema and postoperative non-re-expansion of the lung
  measure: Systemic levels of inflammatory and oxidative markers
  time frame: at a maximum 2 hours after the end of the thoracic procedure
  description: Plasma levels of IL-6, IL-8, IL-1, TNF and malondialdehyde equivalents
  arm group label: one-lung ventilation
  arm group type: Other
  description: Usual care. One lung ventilation will be provided using a Carleans type double lumen orotracheal tube.
  arm group label: two-lung ventilation and use of pneumothorax with CO2.
  arm group type: Experimental
  description: Two lung ventilation will be provided using a single lumen orotracheal tube and CO2-induced pneumothorax
  intervention type: Procedure
  intervention name: two lung ventilation
  description: The intervention do not involve a drug or device. It will be compared two different approaches to ventilate the lungs during the procedure . In this arm both lungs will be ventilated inserting a disposable trocar into the pleural cavity, and insufflating CO2 into the thoracic cavity via an insufflator. The insufflation pressure and the flow rate will be set as 8 mmHg and 10 l.min-1, of the cavity with CO2. The insufflator will be adjusted for cavity pressure in 8mmHg and flow of 10L/min.
  arm group label: two-lung ventilation and use of pneumothorax with CO2.
  intervention type: Procedure
  intervention name: one lung ventilation
  description: In this arm only one lung (the contralateral lung) will be ventilated using a Carlens type orotracheal tube
  arm group label: one-lung ventilation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Eduardo Balleter, MD
  role: Principal Investigator
  affiliation: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
  last name: Felipe Dal Pizzol, MD, PhD
  phone: +5548991852300
  email: fdpizzol@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Brazil
  responsible party type: Principal Investigator
  investigator affiliation: Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
  investigator full name: Felipe Dal Pizzol
  investigator title: Professor
  mesh term: Thoracic Diseases
  sharing ipd: Undecided