<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/NCT01729637</url>
  </required_header>
  <id_info>
    <org_study_id>SI-EVLP</org_study_id>
    <nct_id>NCT01729637</nct_id>
  </id_info>
  <brief_title>SI-EVLP Study: STRESS INDEX in Lung Reconditioning</brief_title>
  <official_title>Normothermic Ex-vivo Lung Perfusion: Clinical Experience of the Pressure/Time Curve Profile Study (Stress Index)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Turin, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Turin, Italy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In order to minimize mechanical stress the investigators propose to implement EVLP procedure&#xD;
      with a ventilation monitoring guided by the analysis of the Paw-t shape.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Increase of interest about technique of Ex-Vivo Lung Perfusion (EVLP) has highlighted the&#xD;
      need of new approaches to respiratory mechanics monitoring to prevent lung stress in atypical&#xD;
      physiological settings.&#xD;
&#xD;
      Airway pressure/time curve (Paw-t) shape analysis at constant flow ventilation (Stress Index,&#xD;
      SI) is thought to be predictor of lung stress; so the SI coefficient may therefore identify&#xD;
      and quantify mechanical stress during ventilation. (1) In experimental studies, the threshold&#xD;
      values for SI that best discriminated lungs with signs of Ventilator Induced Lung Injury&#xD;
      ranged between 0.9 and 1.1. (2) During EVLP, the isolated lungs are free from the effect of&#xD;
      chest wall impairment and represent the effective response of lung parenchyma to ventilatory&#xD;
      setting.&#xD;
&#xD;
      Use of SI monitoring in isolated and perfuse lung reconditioning, may be an useful tool to&#xD;
      prevent hyperinflation and opening-closing conditions by titrating optimal protective&#xD;
      ventilation As previously reported by our group, in the first trial of lung reconditioning,&#xD;
      signs of mechanical stress were detected with Paw-t curve. (3) Therefore we implemented EVLP&#xD;
      procedure with continuous stress index analysis to detect and quantify the occurrence of&#xD;
      hyperinflation or opening closing condition.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">February 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of mechanical stress as assessed by analysis of the &quot;Stress Index&quot;</measure>
    <time_frame>During EVLP procedure (4 hours)</time_frame>
    <description>Stress index is the exponential coefficient of the equation describing the shape of the airway opening pressure vs time (Paw-t) curve during constant flow. This approach is based on the observation that, at constant flow the rate of change of the Paw-t curve corresponds to the rate of change of the compliance of the respiratory system during tidal inflation. A progressive increase in slope (i.e. a downward concavity of the curve) indicates that compliance is progressively increasing with tidal inflation (tidal recruitment). A progressive decrease in slope (i.e. a upward convexity of the curve) indicates that compliance is decreasing with tidal inflation (tidal hyperinflation). Clinical and experimental data show that presence of Stress Index values indicating mechanical stress are associated to morphological, histological and inflammatory evidence of ventilator induce lung injury.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Association between values of Stress Index and occurrence of physiological criteria for EVLP success</measure>
    <time_frame>During EVLP procedure (4 hours)</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">11</enrollment>
  <condition>Lung Transplantation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        consecutive patient sampling from University Ward of Cardio Surgery of St. Giovanni&#xD;
        Battista Hospital of Turin&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  High risk donor lung, define as:&#xD;
&#xD;
          -  the ratio of partial pressure arterial oxygen and fraction of inspired oxygen less&#xD;
             than 300&#xD;
&#xD;
          -  pulmonary edema&#xD;
&#xD;
          -  poor lung deflation or inflation&#xD;
&#xD;
          -  blood transfusions exceeding 10 units&#xD;
&#xD;
          -  donation after cardiac death as defined by Maastricht category III o IV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  donors lung with established pneumonia&#xD;
&#xD;
          -  donors lung with severe mechanical lung injury&#xD;
&#xD;
          -  donors lung with gross gastric aspiration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pier Paolo Terragni, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Turin - Department of Anesthesia and Intensive Care Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Turin - Department of Anesthesia and Intensive Care Medicine</name>
      <address>
        <city>Turin</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>July 2013</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>July 5, 2013</last_update_submitted>
  <last_update_submitted_qc>July 5, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 8, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Turin, Italy</investigator_affiliation>
    <investigator_full_name>Marco Ranieri</investigator_full_name>
    <investigator_title>MD Professor</investigator_title>
  </responsible_party>
  <keyword>Lung Transplantation</keyword>
  <keyword>Respiratory Mechanics</keyword>
  <keyword>Isolated lung perfusion</keyword>
  <keyword>Ex-vivo lung perfusion</keyword>
  <keyword>Lung mechanics</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/NCT01729637
org study id: SI-EVLP
nct id: NCT01729637
lead sponsor: 
has dmc: No
In order to minimize mechanical stress the investigators propose to implement EVLP procedure
      with a ventilation monitoring guided by the analysis of the Paw-t shape.
Increase of interest about technique of Ex-Vivo Lung Perfusion (EVLP) has highlighted the
      need of new approaches to respiratory mechanics monitoring to prevent lung stress in atypical
      physiological settings.

      Airway pressure/time curve (Paw-t) shape analysis at constant flow ventilation (Stress Index,
      SI) is thought to be predictor of lung stress; so the SI coefficient may therefore identify
      and quantify mechanical stress during ventilation. (1) In experimental studies, the threshold
      values for SI that best discriminated lungs with signs of Ventilator Induced Lung Injury
      ranged between 0.9 and 1.1. (2) During EVLP, the isolated lungs are free from the effect of
      chest wall impairment and represent the effective response of lung parenchyma to ventilatory
      setting.

      Use of SI monitoring in isolated and perfuse lung reconditioning, may be an useful tool to
      prevent hyperinflation and opening-closing conditions by titrating optimal protective
      ventilation As previously reported by our group, in the first trial of lung reconditioning,
      signs of mechanical stress were detected with Paw-t curve. (3) Therefore we implemented EVLP
      procedure with continuous stress index analysis to detect and quantify the occurrence of
      hyperinflation or opening closing condition.
time perspective: Prospective
measure: Presence of mechanical stress as assessed by analysis of the "Stress Index"
time frame: During EVLP procedure (4 hours)
description: Stress index is the exponential coefficient of the equation describing the shape of the airway opening pressure vs time (Paw-t) curve during constant flow. This approach is based on the observation that, at constant flow the rate of change of the Paw-t curve corresponds to the rate of change of the compliance of the respiratory system during tidal inflation. A progressive increase in slope (i.e. a downward concavity of the curve) indicates that compliance is progressively increasing with tidal inflation (tidal recruitment). A progressive decrease in slope (i.e. a upward convexity of the curve) indicates that compliance is decreasing with tidal inflation (tidal hyperinflation). Clinical and experimental data show that presence of Stress Index values indicating mechanical stress are associated to morphological, histological and inflammatory evidence of ventilator induce lung injury.
measure: Association between values of Stress Index and occurrence of physiological criteria for EVLP success
time frame: During EVLP procedure (4 hours)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Pier Paolo Terragni, MD
role: Principal Investigator
affiliation: University of Turin - Department of Anesthesia and Intensive Care Medicine
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Turin, Italy
investigator full name: Marco Ranieri
investigator title: MD Professor