<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/NCT02229591</url>
  </required_header>
  <id_info>
    <org_study_id>17082014</org_study_id>
    <nct_id>NCT02229591</nct_id>
  </id_info>
  <brief_title>Expiratory Flow Limitation and Postoperative Complications</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>
      Expiratory flow limitation (EFL) occurs when flow ceases to increase with increasing&#xD;
      expiratory effort. In any circumstances EFL predisposes to pulmonary dynamic hyperinflation&#xD;
      and its unfavorable effects such as increased elastic work of breathing, inspiratory muscles&#xD;
      dysfunction, and progressive neuroventilatory dissociation, leading to reduced exercise&#xD;
      tolerance, marked breathlessness during effort, and severe chronic dyspnea. Our hypothesis is&#xD;
      that EFL should affect post operative outcomes like incidence of pulmonary complication and&#xD;
      length of stay in hospital&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">August 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 complication</measure>
    <time_frame>28 days</time_frame>
    <description>Postoperative pulmonary complication such infection, acute respiratory distress, post operative desaturation</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">330</enrollment>
  <condition>Postoperative Respiratory Complications</condition>
  <arm_group>
    <arm_group_label>EFL patients</arm_group_label>
    <description>Patients with Expiratory Flow Limitation undergoing surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Patients withouth Expiratory Flow Limitation undergoing surgery</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing abdominal, thyroid or vascular surgery in Sant'Anna Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  General anesthesia&#xD;
&#xD;
          -  Duration of the surgery &gt;2 hours&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt;18 years&#xD;
&#xD;
          -  Consensus not given&#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>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 1, 2014</study_first_posted>
  <last_update_submitted>October 25, 2016</last_update_submitted>
  <last_update_submitted_qc>October 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 26, 2016</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>Universitary Researcher</investigator_title>
  </responsible_party>
  <!-- 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/NCT02229591
org study id: 17082014
nct id: NCT02229591
lead sponsor: 
has dmc: Yes
Expiratory flow limitation (EFL) occurs when flow ceases to increase with increasing
      expiratory effort. In any circumstances EFL predisposes to pulmonary dynamic hyperinflation
      and its unfavorable effects such as increased elastic work of breathing, inspiratory muscles
      dysfunction, and progressive neuroventilatory dissociation, leading to reduced exercise
      tolerance, marked breathlessness during effort, and severe chronic dyspnea. Our hypothesis is
      that EFL should affect post operative outcomes like incidence of pulmonary complication and
      length of stay in hospital
observational model: Cohort
time perspective: Prospective
measure: Pulmonary complication
time frame: 28 days
description: Postoperative pulmonary complication such infection, acute respiratory distress, post operative desaturation
arm group label: EFL patients
description: Patients with Expiratory Flow Limitation undergoing surgery
arm group label: Control group
description: Patients withouth Expiratory Flow Limitation undergoing surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Università degli Studi di Ferrara
investigator full name: Savino Spadaro
investigator title: Universitary Researcher