<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/NCT03814538</url>
  </required_header>
  <id_info>
    <org_study_id>876/2018/OSS/AOUPR</org_study_id>
    <nct_id>NCT03814538</nct_id>
  </id_info>
  <brief_title>Expiratory Flow Limitation in Thoracic Surgery (EFLinTOR)</brief_title>
  <acronym>(EFLinTOR)</acronym>
  <official_title>Assessment of the Incidence of Expiratory Flow Limitation in Patients Undergoing Thoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Parma</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Parma</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background and rationale of the study: During general anesthesia, the residual functional&#xD;
      capacity (FRC) is reduced. If the FRC is lower than the minimum volume necessary to maintain&#xD;
      the airway opening (closing capacity, CC), a pulmonary parenchyma derecruitment leads to the&#xD;
      phenomenon of expiratory flow limitation (EFL). In recent years, new methods are being&#xD;
      studied to assess EFL. In the study by Marangoni E, et. al., has been shown how the sudden&#xD;
      subtraction of 3 cmH2O to the value of the tele-expiratory positive pressure (PEEP test) is&#xD;
      sufficient to establish the presence of the EFL.&#xD;
&#xD;
      The presence of EFL measured by this method seems to correlate, in abdominal surgery, with&#xD;
      the development of post-operative pulmonary complications. In the area of anesthesia in&#xD;
      thoracic surgery, neither the incidence nor the relevance of the EFL are known, so a study is&#xD;
      needed that evaluates both.&#xD;
&#xD;
      The aim of the study is to determine the incidence of expiratory flow limitation in patients&#xD;
      undergoing thoracic surgery and ventilated in bi and monopolmonary mode.&#xD;
&#xD;
      The protective ventilation is a mechanical ventilation with a current volume (TV) of 6-8 mL /&#xD;
      kg among to the ideal body weight (IBW), PEEP of 3-5 cmH2O and a FiO2 &lt;80%.&#xD;
&#xD;
      The aim of this study is to evaluate the incidence of EFL in patients undergoing thoracic&#xD;
      surgery, planned by thoracoscopy and thoracotomy in election, and to correlate this parameter&#xD;
      with the onset of postoperative pulmonary complications. The final aim will be to verify if&#xD;
      it is possible to identify a better approach, through the personalization of mechanical&#xD;
      ventilation during the surgery, to reduce mortality, morbidity and hospital stay after&#xD;
      thoracic surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It's a prospective and observational study, with 100 patients that undergo thoracic surgery.&#xD;
&#xD;
      The respiratory rate will be set to maintain PaCO2 at values close to eucapnia.&#xD;
&#xD;
      Controlled pressure ventilation (Pinsp ≤ 35 cmH2O) will be used only if the maximum airway&#xD;
      pressures are reached and exceeded with controlled ventilation.&#xD;
&#xD;
      The inspiratory mixture will consist of O2: Air and possibly the halogenated anesthetic.&#xD;
&#xD;
      At the end of the operation, the patients will be transferred to Intensive Care Unit for&#xD;
      post-operative monitoring. During the transfer will be supported with mechanical ventilation&#xD;
      manually performed by the Anesthesiologist.&#xD;
&#xD;
      The extubation will be performed in TICCH, according to the practice of the center.&#xD;
&#xD;
      Patients will be asked to join the study by giving informed consent.&#xD;
&#xD;
      The data will be collected through a special data collection form (Case Report Form, CRF).&#xD;
&#xD;
      The following information will be collected:&#xD;
&#xD;
      In the section dedicated to the preoperative patient data will be inserted related to:&#xD;
&#xD;
        -  age, weight, height, sex;&#xD;
&#xD;
        -  general health conditions&#xD;
&#xD;
        -  previous and concurrent diseases&#xD;
&#xD;
        -  positive respiratory history for: previous pleuro-parenchymal diseases in the 30 days&#xD;
           prior to surgery, previous interventions on the thorax, pleura or lung, presence of&#xD;
           pleural effusion; asthma; Chronic obstructive pulmonary disease.&#xD;
&#xD;
        -  history of cigarette smoking: active smoker (number of cigarettes), ex-smoker or&#xD;
           non-smoker;&#xD;
&#xD;
        -  Preoperative Therapy&#xD;
&#xD;
        -  SpO2, PaO2, PaO2 / FiO2, PaCO2 (if available);&#xD;
&#xD;
        -  cardiological anamnesis (echocardiography, ECG, etc.) other medical information relevant&#xD;
           to the study&#xD;
&#xD;
      The following data will be collected on the intra-operative card:&#xD;
&#xD;
        -  incidence of EFL and respiratory mechanics parameters, collected by the ventilator;&#xD;
&#xD;
        -  type of surgical intervention;&#xD;
&#xD;
        -  transfusion of blood derivatives;&#xD;
&#xD;
        -  eventual administration of cardio / vasoactive drugs;&#xD;
&#xD;
        -  duration of the surgery; other information related to the intra-operative relevant for&#xD;
           the purpose of the study&#xD;
&#xD;
      The EFL will be registered at the following time-points:&#xD;
&#xD;
        -  after the induction of anesthesia;&#xD;
&#xD;
        -  after lateral positioning of the patient;&#xD;
&#xD;
        -  start of One Lung Ventilation;&#xD;
&#xD;
        -  5 ' after cutting skin;&#xD;
&#xD;
        -  30 ' after cutting skin;&#xD;
&#xD;
        -  5 ' after closing skin;&#xD;
&#xD;
        -  Bipulmonary ventilation;&#xD;
&#xD;
        -  Positioning of the back of the patient.&#xD;
&#xD;
      The following data will be recorded in the postoperative card:&#xD;
&#xD;
        -  Post-operative mechanical ventilation time&#xD;
&#xD;
        -  postoperative respiratory complications;&#xD;
&#xD;
        -  postoperative non-respiratory (cardiovascular, infectious, renal, surgical)&#xD;
           complications;&#xD;
&#xD;
        -  need for re-intubation in the postoperative period;&#xD;
&#xD;
        -  need for ventilatory support (non-invasive ventilation, invasive ventilation) in the&#xD;
           postoperative period;&#xD;
&#xD;
        -  need for hospitalization in intensive care (expected, unexpected, cause of&#xD;
           hospitalization, length of stay);&#xD;
&#xD;
        -  duration of hospital stay; other postoperative information relevant for the purpose of&#xD;
           the study.&#xD;
&#xD;
      Data will be analyzed using statistical software.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</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>Incidence of EFL</measure>
    <time_frame>From the induction of general anesthesia, until the end of the surgical procedure, up to 10 hours</time_frame>
    <description>Evaluate the incidence of the EFL in patients undergoing thoracic surgery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of postoperative pulmonary complications (PPC) related to EFL</measure>
    <time_frame>From immediately after surgery until hospital discharge, up to 26 weeks</time_frame>
    <description>Evaluate the relationship between the incidence of EFL and the onset of PPC in patients undergoing thoracic surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of length of in-hospital stay</measure>
    <time_frame>From immediately after surgery until hospital discharge, up to 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of Intensive Care Unit admission and its duration</measure>
    <time_frame>From immediately after surgery until hospital discharge, up to 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation</measure>
    <time_frame>From immediately after surgery until hospital discharge, up to 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of cardiovascular postoperative complications</measure>
    <time_frame>From immediately after surgery until hospital discharge, up to 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of neurological postoperative complications</measure>
    <time_frame>From immediately after surgery until hospital discharge, up to 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of surgical postoperative complications</measure>
    <time_frame>From immediately after surgery until hospital discharge, up to 26 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of mortality</measure>
    <time_frame>From immediately after surgery until hospital discharge, up to 26 weeks</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Thoracic Surgery</condition>
  <condition>General Anesthesia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        non critical ill patients (with no high risk of desaturation) undergoing general anesthesia&#xD;
        before elective surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age &gt;18 years old&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
          -  elective thoracic surgery&#xD;
&#xD;
          -  planned thoracic surgery with thoracotomy and thoracosthomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Patients undergoing emergency or emergency surgery&#xD;
&#xD;
          -  Patients underwent cardiac and surgery&#xD;
&#xD;
          -  patients underwent thoracic surgery with median sthernotomy&#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>Michela Tosi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Benedetta Siroli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Samantha Gorgoglione, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Valentina Bellini, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anna Cozzolino, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Parma</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Cristina Montanino, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Parma</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Elena Giovann Bignami, Professor</last_name>
    <phone>+390521033609</phone>
    <email>elenagiovanna.bignami@unipr.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Azienda Ospedaliera-Universitaria di Parma</name>
      <address>
        <city>Parma</city>
        <zip>43125</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elena Giovanna Bignami, MD Professor</last_name>
      <phone>+390521703567</phone>
      <email>elenagiovanna.bignami@unipr.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>January 22, 2019</last_update_submitted>
  <last_update_submitted_qc>January 22, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 24, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Parma</investigator_affiliation>
    <investigator_full_name>Elena Giovanna Bignami</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Postoperative pulmonary complications</keyword>
  <keyword>Incidence of EFL</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Dissection</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/NCT03814538
org study id: 876/2018/OSS/AOUPR
nct id: NCT03814538
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background and rationale of the study: During general anesthesia, the residual functional
      capacity (FRC) is reduced. If the FRC is lower than the minimum volume necessary to maintain
      the airway opening (closing capacity, CC), a pulmonary parenchyma derecruitment leads to the
      phenomenon of expiratory flow limitation (EFL). In recent years, new methods are being
      studied to assess EFL. In the study by Marangoni E, et. al., has been shown how the sudden
      subtraction of 3 cmH2O to the value of the tele-expiratory positive pressure (PEEP test) is
      sufficient to establish the presence of the EFL.

      The presence of EFL measured by this method seems to correlate, in abdominal surgery, with
      the development of post-operative pulmonary complications. In the area of anesthesia in
      thoracic surgery, neither the incidence nor the relevance of the EFL are known, so a study is
      needed that evaluates both.

      The aim of the study is to determine the incidence of expiratory flow limitation in patients
      undergoing thoracic surgery and ventilated in bi and monopolmonary mode.

      The protective ventilation is a mechanical ventilation with a current volume (TV) of 6-8 mL /
      kg among to the ideal body weight (IBW), PEEP of 3-5 cmH2O and a FiO2 <80%.

      The aim of this study is to evaluate the incidence of EFL in patients undergoing thoracic
      surgery, planned by thoracoscopy and thoracotomy in election, and to correlate this parameter
      with the onset of postoperative pulmonary complications. The final aim will be to verify if
      it is possible to identify a better approach, through the personalization of mechanical
      ventilation during the surgery, to reduce mortality, morbidity and hospital stay after
      thoracic surgery.
It's a prospective and observational study, with 100 patients that undergo thoracic surgery.

      The respiratory rate will be set to maintain PaCO2 at values close to eucapnia.

      Controlled pressure ventilation (Pinsp ≤ 35 cmH2O) will be used only if the maximum airway
      pressures are reached and exceeded with controlled ventilation.

      The inspiratory mixture will consist of O2: Air and possibly the halogenated anesthetic.

      At the end of the operation, the patients will be transferred to Intensive Care Unit for
      post-operative monitoring. During the transfer will be supported with mechanical ventilation
      manually performed by the Anesthesiologist.

      The extubation will be performed in TICCH, according to the practice of the center.

      Patients will be asked to join the study by giving informed consent.

      The data will be collected through a special data collection form (Case Report Form, CRF).

      The following information will be collected:

      In the section dedicated to the preoperative patient data will be inserted related to:

        -  age, weight, height, sex;

        -  general health conditions

        -  previous and concurrent diseases

        -  positive respiratory history for: previous pleuro-parenchymal diseases in the 30 days
           prior to surgery, previous interventions on the thorax, pleura or lung, presence of
           pleural effusion; asthma; Chronic obstructive pulmonary disease.

        -  history of cigarette smoking: active smoker (number of cigarettes), ex-smoker or
           non-smoker;

        -  Preoperative Therapy

        -  SpO2, PaO2, PaO2 / FiO2, PaCO2 (if available);

        -  cardiological anamnesis (echocardiography, ECG, etc.) other medical information relevant
           to the study

      The following data will be collected on the intra-operative card:

        -  incidence of EFL and respiratory mechanics parameters, collected by the ventilator;

        -  type of surgical intervention;

        -  transfusion of blood derivatives;

        -  eventual administration of cardio / vasoactive drugs;

        -  duration of the surgery; other information related to the intra-operative relevant for
           the purpose of the study

      The EFL will be registered at the following time-points:

        -  after the induction of anesthesia;

        -  after lateral positioning of the patient;

        -  start of One Lung Ventilation;

        -  5 ' after cutting skin;

        -  30 ' after cutting skin;

        -  5 ' after closing skin;

        -  Bipulmonary ventilation;

        -  Positioning of the back of the patient.

      The following data will be recorded in the postoperative card:

        -  Post-operative mechanical ventilation time

        -  postoperative respiratory complications;

        -  postoperative non-respiratory (cardiovascular, infectious, renal, surgical)
           complications;

        -  need for re-intubation in the postoperative period;

        -  need for ventilatory support (non-invasive ventilation, invasive ventilation) in the
           postoperative period;

        -  need for hospitalization in intensive care (expected, unexpected, cause of
           hospitalization, length of stay);

        -  duration of hospital stay; other postoperative information relevant for the purpose of
           the study.

      Data will be analyzed using statistical software.
observational model: Cohort
time perspective: Prospective
measure: Incidence of EFL
time frame: From the induction of general anesthesia, until the end of the surgical procedure, up to 10 hours
description: Evaluate the incidence of the EFL in patients undergoing thoracic surgery
measure: Incidence of postoperative pulmonary complications (PPC) related to EFL
time frame: From immediately after surgery until hospital discharge, up to 26 weeks
description: Evaluate the relationship between the incidence of EFL and the onset of PPC in patients undergoing thoracic surgery
measure: Incidence of length of in-hospital stay
time frame: From immediately after surgery until hospital discharge, up to 26 weeks
measure: Incidence of Intensive Care Unit admission and its duration
time frame: From immediately after surgery until hospital discharge, up to 26 weeks
measure: Duration of mechanical ventilation
time frame: From immediately after surgery until hospital discharge, up to 26 weeks
measure: Incidence of cardiovascular postoperative complications
time frame: From immediately after surgery until hospital discharge, up to 26 weeks
measure: Incidence of neurological postoperative complications
time frame: From immediately after surgery until hospital discharge, up to 26 weeks
measure: Incidence of surgical postoperative complications
time frame: From immediately after surgery until hospital discharge, up to 26 weeks
measure: Incidence of mortality
time frame: From immediately after surgery until hospital discharge, up to 26 weeks
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Michela Tosi, MD
role: Principal Investigator
affiliation: University of Parma
last name: Benedetta Siroli, MD
role: Principal Investigator
affiliation: University of Parma
last name: Samantha Gorgoglione, MD
role: Principal Investigator
affiliation: University of Parma
last name: Valentina Bellini, MD
role: Principal Investigator
affiliation: University of Parma
last name: Anna Cozzolino, MD
role: Principal Investigator
affiliation: University of Parma
last name: Cristina Montanino, MD
role: Principal Investigator
affiliation: University of Parma
last name: Elena Giovann Bignami, Professor
phone: +390521033609
email: elenagiovanna.bignami@unipr.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Parma
investigator full name: Elena Giovanna Bignami
investigator title: Professor
mesh term: Aortic Dissection