<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/NCT02968550</url>
  </required_header>
  <id_info>
    <org_study_id>SEAT</org_study_id>
    <nct_id>NCT02968550</nct_id>
  </id_info>
  <brief_title>Shunt Evaluation With ALPE System in Thoracic Surgery</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università degli Studi di Ferrara</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università degli Studi di Ferrara</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      . The aim of this study, thus, is to evaluate shunt fraction and markers of alveolar distress&#xD;
      during one lung ventilation (OLV) at different levels of positive end expiratory pressure&#xD;
      (PEEP). Moreover, investigators will focus on predicting factors of high shunt levels during&#xD;
      OLV.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Pulmonary shunt evaluated with ALPE system</measure>
    <time_frame>every 30 minutes after the start of surgery up to 3 evaluations, up to 90 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>predictors of high intraoperative shunt</measure>
    <time_frame>The outcome is assessed 15 minutes after one lung ventilation</time_frame>
    <description>All patients admitted to the study received a preoperative physiologic assessment with a cardiovascular evaluation and spirometry. After 15 minutes of one lung ventilation, the pulmonary shunt is evaluated. Therefore, all clinical variable evaluated during preoperative assessment will be compared with the pulmonary shunt</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">41</enrollment>
  <condition>Mechanical Ventilation</condition>
  <condition>Thoracic Diseases</condition>
  <arm_group>
    <arm_group_label>Low shunt group</arm_group_label>
    <description>patients with shunt less than 30% in one-lung ventilation at ZEEP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High shunt group</arm_group_label>
    <description>Patients with shunt equal or more than 30% in one-lung ventilation at ZEEP</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing thoracoscopic surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients scheduled for thoracoscopic lobectomy or thoracoscopic wedge resection in&#xD;
             lateral decubitus.&#xD;
&#xD;
          -  patients American Society of Anesthesiologists Physical Status Classiﬁcation score of&#xD;
             1-3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with hemodynamic instability,&#xD;
&#xD;
          -  Patients with severe chronic respiratory failure&#xD;
&#xD;
          -  Patients with preoperative anemia (hemoglobin &lt;10 g 100 ml-1)&#xD;
&#xD;
          -  Patients requiring unplanned conversion to thoracotomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria Sant'Anna</name>
      <address>
        <city>Ferrara</city>
        <zip>44121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Beck DH, Doepfmer UR, Sinemus C, Bloch A, Schenk MR, Kox WJ. Effects of sevoflurane and propofol on pulmonary shunt fraction during one-lung ventilation for thoracic surgery. Br J Anaesth. 2001 Jan;86(1):38-43. doi: 10.1093/bja/86.1.38.</citation>
    <PMID>11575407</PMID>
  </reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>November 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>March 29, 2017</last_update_submitted>
  <last_update_submitted_qc>March 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università degli Studi di Ferrara</investigator_affiliation>
    <investigator_full_name>Savino Spadaro</investigator_full_name>
    <investigator_title>MD</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>
  <!-- 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/NCT02968550
org study id: SEAT
nct id: NCT02968550
lead sponsor: 
has dmc: Yes
. The aim of this study, thus, is to evaluate shunt fraction and markers of alveolar distress
      during one lung ventilation (OLV) at different levels of positive end expiratory pressure
      (PEEP). Moreover, investigators will focus on predicting factors of high shunt levels during
      OLV.
observational model: Cohort
time perspective: Prospective
measure: Pulmonary shunt evaluated with ALPE system
time frame: every 30 minutes after the start of surgery up to 3 evaluations, up to 90 minutes
measure: predictors of high intraoperative shunt
time frame: The outcome is assessed 15 minutes after one lung ventilation
description: All patients admitted to the study received a preoperative physiologic assessment with a cardiovascular evaluation and spirometry. After 15 minutes of one lung ventilation, the pulmonary shunt is evaluated. Therefore, all clinical variable evaluated during preoperative assessment will be compared with the pulmonary shunt
arm group label: Low shunt group
description: patients with shunt less than 30% in one-lung ventilation at ZEEP
arm group label: High shunt group
description: Patients with shunt equal or more than 30% in one-lung ventilation at ZEEP
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
citation: Beck DH, Doepfmer UR, Sinemus C, Bloch A, Schenk MR, Kox WJ. Effects of sevoflurane and propofol on pulmonary shunt fraction during one-lung ventilation for thoracic surgery. Br J Anaesth. 2001 Jan;86(1):38-43. doi: 10.1093/bja/86.1.38.
PMID: 11575407
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi di Ferrara
investigator full name: Savino Spadaro
investigator title: MD
mesh term: Thoracic Diseases