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/NCT05977153</url>
    </required_header>
    <id_info>
      <org_study_id>AAAT8623</org_study_id>
      <secondary_id>5R01HL121228-09</secondary_id>
      <nct_id>NCT05977153</nct_id>
    </id_info>
    <brief_title>CT for Personalized Mechanical Ventilation</brief_title>
    <official_title>CT-Guided Personalized Mechanical Ventilation to Minimize Ventilator-Induced Lung Injury Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Columbia University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Columbia University</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 study is to compare two different ways of helping patients with a condition&#xD;
        called sepsis who need help breathing using a machine called a ventilator. The investigators&#xD;
        want to study which way of setting the ventilator is better for the lungs.&#xD;
  &#xD;
        Here are the main questions the investigators want to answer:&#xD;
  &#xD;
          1. How does the amount of air in the lungs and the way it moves differ between the two&#xD;
             ways?&#xD;
  &#xD;
          2. How does the way air spreads out in different parts of the lungs differ between the two&#xD;
             ways? In this study, the investigators will take special pictures of the lungs using a&#xD;
             machine called a CT scan. The pictures will show us how much the lungs stretch and how&#xD;
             much air is in different parts of the lungs. The investigators will compare two&#xD;
             different ways of using the ventilator: one personalized for each patient based on their&#xD;
             breathing, and another way that is commonly used.&#xD;
  &#xD;
        By comparing these two ways, the investigators hope to learn which one is better for helping&#xD;
        patients with sepsis who need the ventilator. This information can help doctors make better&#xD;
        decisions about how to care for these patients and improve their breathing.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Mechanical ventilation is a key life support method applied to millions of surgical and&#xD;
        critically ill patients. Ventilator-induced lung injury (VILI) is a major factor for&#xD;
        morbidity and mortality in patients with the acute respiratory distress syndrome (ARDS), the&#xD;
        most severe form of respiratory dysfunction. Furthermore, mechanical ventilation settings&#xD;
        also contribute to the risk for postoperative pulmonary complications (PPCs) in surgical&#xD;
        patients and lung injury in critically ill patients with normal lungs at onset of&#xD;
        ventilation. In summary, mitigation of VILI is critical to reduce perioperative and critical&#xD;
        care morbidity and mortality, with major impact on outcomes and health care costs.&#xD;
  &#xD;
        In this project, we propose to apply novel CT methods to assess spatial distributions of&#xD;
        strain and aeration and establish measures of global lung mechanics best indicative of the&#xD;
        PEEP leading to least injurious distributions and, thus, least VILI.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 10, 2023</start_date>
    <completion_date type="Anticipated">February 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 1, 2025</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>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Squared coefficient of variation of the tidal volumetric strain</measure>
      <time_frame>48 hours</time_frame>
      <description>Squared coefficient of variation (=variance normalized by the squared mean) of the tidal volumetric strain will be obtained and calculated from CT images.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Squared coefficient of variation of aeration</measure>
      <time_frame>48 hours</time_frame>
      <description>Squared coefficient of variation (=variance normalized by the squared mean) of aeration obtained and calculated from CT images.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average gas fraction</measure>
      <time_frame>48 hours</time_frame>
      <description>Average gas fraction will be obtained and calculated from CT images.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distribution of aeration categories</measure>
      <time_frame>48 hours</time_frame>
      <description>Distribution of aeration categories (non-aerated, poorly aerated, normally aerated and hyperinflated regions) will be obtained and calculated from CT images.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average tidal strain</measure>
      <time_frame>48 hours</time_frame>
      <description>Average of voxel level volumetric tidal strain will be obtained and calculated from CT images.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Time during mechanical ventilation</measure>
      <time_frame>Up to 5 days</time_frame>
      <description>Time during mechanical ventilation will be recorded in days.</description>
    </other_outcome>
    <other_outcome>
      <measure>Detection of Inflammatory cytokines</measure>
      <time_frame>48 hours</time_frame>
      <description>Inflammatory cytokine is a type of signaling molecule (a cytokine) that is secreted from immune cells like helper T cells (Th) and macrophages, and certain other cell types that promote inflammation; their presence will be measured by assays.</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Ventilator-Induced Lung Injury</condition>
    <condition>Sepsis Syndrome</condition>
    <condition>Mechanical Ventilation Complication</condition>
    <arm_group>
      <arm_group_label>Group 1: ARDSNet</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will receive standard ARDSNet low-stretch PEEP (positive end-expiratory pressure) protocol.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2: Individualized PEEP (positive end expiratory pressure) Strategy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive individualized PEEP (positive end-expiratory pressure).</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>PEEP (positive end-expiratory pressure) - maximum</intervention_name>
      <description>Breathing assistance from the breathing assist machine using a method in which doctors try to find the pressures that expands the lungs the best. This is based on measurements of one's respiratory pressures and volumes. This is done by adjusting the pressure settings. This allows one's lungs to expand with the least amount of change in pressure during breathing.&#xD;
  PEEP (positive end-expiratory pressure) will be set at the maximum static respiratory system compliance (Crs) during a descending PEEP titration curve.</description>
      <arm_group_label>Group 2: Individualized PEEP (positive end expiratory pressure) Strategy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>PEEP (positive end-expiratory pressure) - standard</intervention_name>
      <description>Breathing assistance from the breathing assist machine using the pressure settings typical for your disease.&#xD;
  Standard ARDSNet low-stretch PEEP (positive end-expiratory pressure) protocol: PEEP will be set following a routinely used PEEP table according to patients' blood oxygenation status.</description>
      <arm_group_label>Group 1: ARDSNet</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Following onset of mechanical ventilation and not longer than 5 days after intubation.&#xD;
  &#xD;
            -  Sepsis as defined by the most recent criteria:&#xD;
  &#xD;
                 -  Life-threatening organ dysfunction caused by a dysregulated host response to&#xD;
                    infection operationalized by presumed or documented infection and a Sequential&#xD;
                    [Sepsis-related] Organ Failure Assessment (SOFA) score &gt;= 2 or a change by 2 from&#xD;
                    the baseline if baseline known to be different from 0;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Age &lt; 18 years;&#xD;
  &#xD;
            -  Hemodynamic instability, defined as: systolic blood pressure (SBP) &lt; 90 mmHg that is&#xD;
               not adequately stabilized by vasopressors or inotropic agents. For these purposes, SBP&#xD;
               will not be considered &quot;adequately stabilized&quot; if the dose of the vasopressor/inotrope&#xD;
               has not been stable for at least one hour;&#xD;
  &#xD;
            -  Hypoxemia, defined as: PaO2 &lt; 70 mmHg on an inspired oxygen fraction (FiO2) greater&#xD;
               than or equal to 0.9;&#xD;
  &#xD;
            -  Hemodynamic and/or respiratory instability (as defined, in items 2 and 3) that develop&#xD;
               when the patient is mobilized during routine nursing care such as&#xD;
               repositioning/washing the patient or changing their bed linens;&#xD;
  &#xD;
            -  Hemodynamic and/or respiratory instability (as defined, in items 2 and 3) that develop&#xD;
               when a 20 second respiratory pause is required to implement the study protocol. This&#xD;
               will be tested by inducing such a pause prior to transporting the patient;&#xD;
  &#xD;
            -  Any acute or chronic condition which, in the opinion of the investigators, might&#xD;
               confound the imaging measurements (such as, but not limited to, severe bronchospasm,&#xD;
               pulmonary infection, and lung tumor);&#xD;
  &#xD;
            -  Any acute or chronic condition which, in the opinion of the investigators or managing&#xD;
               critical care team, could prevent safe transport to the CT suite.&#xD;
  &#xD;
            -  &quot;Air leaks&quot; requiring tube thoracotomy (e.g., pneumothorax, bronchopleural fistula);&#xD;
  &#xD;
            -  Body mass index &gt; 40 kg/m2;&#xD;
  &#xD;
            -  Pregnancy (since this is a study that would expose a fetus to radiation risk);&#xD;
  &#xD;
            -  Patients who have taken part in other research studies involving radiation exposure,&#xD;
               or those patients for whom this research radiation history is unavailable at the time&#xD;
               of consent.&#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>Marcos F VIdal Melo, MD/PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Columbia University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marcos F Vidal Melo, MD/PhD</last_name>
      <phone>16178185934</phone>
      <email>mv2869@cumc.columbia.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Columbia University</name>
        <address>
          <city>New York</city>
          <state>New York</state>
          <zip>10025</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Marcos F Vidal Melo, MD/PhD</last_name>
        <phone>617-818-5934</phone>
        <email>mv2869@cumc.columbia.edu</email>
      </contact>
      <contact_backup>
        <last_name>Gebhard Wagener, MD</last_name>
        <email>gw72@cumc.columbia.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Marcos F VIdal Melo, MD/PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Columbia University</investigator_affiliation>
      <investigator_full_name>Marcos Vidal Melo</investigator_full_name>
      <investigator_title>Professor of Anesthesiology</investigator_title>
    </responsible_party>
    <keyword>Computed Tomography</keyword>
    <keyword>Registration Analysis</keyword>
    <keyword>Functional Lung Imaging</keyword>
    <keyword>Acute Lung Injury</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Toxemia</mesh_term>
      <mesh_term>Sepsis</mesh_term>
      <mesh_term>Lung Injury</mesh_term>
      <mesh_term>Ventilator-Induced Lung Injury</mesh_term>
      <mesh_term>Systemic Inflammatory Response Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>This is a NIH funded study. Data sharing will follow NIH guidelines.</ipd_description>
    </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/NCT05977153
  org study id: AAAT8623
  secondary id: 5R01HL121228-09
  nct id: NCT05977153
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to compare two different ways of helping patients with a condition
        called sepsis who need help breathing using a machine called a ventilator. The investigators
        want to study which way of setting the ventilator is better for the lungs.
  
        Here are the main questions the investigators want to answer:
  
          1. How does the amount of air in the lungs and the way it moves differ between the two
             ways?
  
          2. How does the way air spreads out in different parts of the lungs differ between the two
             ways? In this study, the investigators will take special pictures of the lungs using a
             machine called a CT scan. The pictures will show us how much the lungs stretch and how
             much air is in different parts of the lungs. The investigators will compare two
             different ways of using the ventilator: one personalized for each patient based on their
             breathing, and another way that is commonly used.
  
        By comparing these two ways, the investigators hope to learn which one is better for helping
        patients with sepsis who need the ventilator. This information can help doctors make better
        decisions about how to care for these patients and improve their breathing.
  Mechanical ventilation is a key life support method applied to millions of surgical and
        critically ill patients. Ventilator-induced lung injury (VILI) is a major factor for
        morbidity and mortality in patients with the acute respiratory distress syndrome (ARDS), the
        most severe form of respiratory dysfunction. Furthermore, mechanical ventilation settings
        also contribute to the risk for postoperative pulmonary complications (PPCs) in surgical
        patients and lung injury in critically ill patients with normal lungs at onset of
        ventilation. In summary, mitigation of VILI is critical to reduce perioperative and critical
        care morbidity and mortality, with major impact on outcomes and health care costs.
  
        In this project, we propose to apply novel CT methods to assess spatial distributions of
        strain and aeration and establish measures of global lung mechanics best indicative of the
        PEEP leading to least injurious distributions and, thus, least VILI.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Single (Participant)
  measure: Squared coefficient of variation of the tidal volumetric strain
  time frame: 48 hours
  description: Squared coefficient of variation (=variance normalized by the squared mean) of the tidal volumetric strain will be obtained and calculated from CT images.
  measure: Squared coefficient of variation of aeration
  time frame: 48 hours
  description: Squared coefficient of variation (=variance normalized by the squared mean) of aeration obtained and calculated from CT images.
  measure: Average gas fraction
  time frame: 48 hours
  description: Average gas fraction will be obtained and calculated from CT images.
  measure: Distribution of aeration categories
  time frame: 48 hours
  description: Distribution of aeration categories (non-aerated, poorly aerated, normally aerated and hyperinflated regions) will be obtained and calculated from CT images.
  measure: Average tidal strain
  time frame: 48 hours
  description: Average of voxel level volumetric tidal strain will be obtained and calculated from CT images.
  measure: Time during mechanical ventilation
  time frame: Up to 5 days
  description: Time during mechanical ventilation will be recorded in days.
  measure: Detection of Inflammatory cytokines
  time frame: 48 hours
  description: Inflammatory cytokine is a type of signaling molecule (a cytokine) that is secreted from immune cells like helper T cells (Th) and macrophages, and certain other cell types that promote inflammation; their presence will be measured by assays.
  arm group label: Group 1: ARDSNet
  arm group type: Active Comparator
  description: Participants will receive standard ARDSNet low-stretch PEEP (positive end-expiratory pressure) protocol.
  arm group label: Group 2: Individualized PEEP (positive end expiratory pressure) Strategy
  arm group type: Experimental
  description: Participants will receive individualized PEEP (positive end-expiratory pressure).
  intervention type: Procedure
  intervention name: PEEP (positive end-expiratory pressure) - maximum
  description: Breathing assistance from the breathing assist machine using a method in which doctors try to find the pressures that expands the lungs the best. This is based on measurements of one's respiratory pressures and volumes. This is done by adjusting the pressure settings. This allows one's lungs to expand with the least amount of change in pressure during breathing.
  PEEP (positive end-expiratory pressure) will be set at the maximum static respiratory system compliance (Crs) during a descending PEEP titration curve.
  arm group label: Group 2: Individualized PEEP (positive end expiratory pressure) Strategy
  intervention type: Procedure
  intervention name: PEEP (positive end-expiratory pressure) - standard
  description: Breathing assistance from the breathing assist machine using the pressure settings typical for your disease.
  Standard ARDSNet low-stretch PEEP (positive end-expiratory pressure) protocol: PEEP will be set following a routinely used PEEP table according to patients' blood oxygenation status.
  arm group label: Group 1: ARDSNet
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Marcos F VIdal Melo, MD/PhD
  role: Principal Investigator
  affiliation: Columbia University
  last name: Marcos F Vidal Melo, MD/PhD
  phone: 16178185934
  email: mv2869@cumc.columbia.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Columbia University
  investigator full name: Marcos Vidal Melo
  investigator title: Professor of Anesthesiology
  mesh term: Toxemia
  mesh term: Sepsis
  mesh term: Lung Injury
  mesh term: Ventilator-Induced Lung Injury
  mesh term: Systemic Inflammatory Response Syndrome
  sharing ipd: No
  ipd description: This is a NIH funded study. Data sharing will follow NIH guidelines.