<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/NCT01725971</url>
  </required_header>
  <id_info>
    <org_study_id>Silicose2012</org_study_id>
    <secondary_id>Silicose2012</secondary_id>
    <nct_id>NCT01725971</nct_id>
  </id_info>
  <brief_title>Oscillation Mechanics of the Respiratory System in Never-smoking Patients With Silicosis</brief_title>
  <official_title>The Use of Forced Oscillation Technique in the Analysis of Respiratory System in Never-smoking Patients With Silicosis:Pathophysiological Study and Evaluation of Diagnostic Accuracy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rio de Janeiro State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rio de Janeiro State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Silicosis is a chronic and incurable occupational disease that can progress independent of&#xD;
      the end of exposure. Recent works suggest that the Forced Oscillation Technique (FOT) may&#xD;
      help to improve our understanding of the changes in lung mechanics, as well as in the&#xD;
      detection of these changes.&#xD;
&#xD;
      Objectives: Analyze the effects of airway obstruction in silicosis on the respiratory&#xD;
      impedance and evaluated the diagnostic use of the FOT in these patients. For this, the&#xD;
      investigators used spirometry to classify airway obstruction, which resulted in four&#xD;
      categories: control, patients with normal exam, mild obstruction, and moderate-to-severe&#xD;
      obstruction. Resistive data were interpreted using the zero-intercept resistance (R0), the&#xD;
      resistance at 4 Hz (Rrs4) and the mean resistance (Rm). The investigators also analyzed the&#xD;
      mean reactance (Xm) and the dynamic compliance (Crs,dyn). The total mechanical load was&#xD;
      evaluated using the absolute value of the respiratory impedance (Z4Hz). The diagnostic&#xD;
      potential was evaluated by investigating the area under the receiver operating characteristic&#xD;
      curve (AUC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2010</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">December 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>spirometric</measure>
    <time_frame>1 day</time_frame>
    <description>Spirometry was used to classify airway obstruction, which resulted in four categories: control (n=21), patients with normal exam (n=12), mild obstruction (n=22), and moderate-to-severe obstruction (n=12).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Forced Oscillation technique</measure>
    <time_frame>1 day</time_frame>
    <description>In the analysis of the forced oscillation technique was used the following data: Resistive data were interpreted using the zero-intercept resistance (R0), the resistance at 4 Hz (Rrs4) and the mean resistance (Rm). The researchers also analyzed the mean reactance (Xm) and the dynamic compliance (Crs,dyn). The total mechanical load was evaluated using the absolute value of the respiratory impedance (Z4Hz).</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">67</enrollment>
  <condition>Silicosis</condition>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Group of nonsmokers individuals without respiratory disease.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>normal exam</arm_group_label>
    <description>subjects with silicosis , but with normal spirometric data</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mild obstruction</arm_group_label>
    <description>subjects with silicosis with mild obstruction in spirometric data</description>
  </arm_group>
  <arm_group>
    <arm_group_label>moderate to severe obstruction</arm_group_label>
    <description>subjects with silicosis with moderate to severe obstruction in spirometric data</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The control group will consist of healthy subjects, nonsmokers, who had no episode of&#xD;
        respiratory infection thirty days before the examinations.&#xD;
&#xD;
        The group with diagnosis of silicosis was established based on a history of substantial&#xD;
        exposure to silica dusts and compatible radiological features, together with exclusion of&#xD;
        other competing diagnoses.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Volunteers with silicosis for Patients Group;&#xD;
&#xD;
               -  Volunteers without any respiratory disease for the control group.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Laboratório de Instrumentação Biomédica</name>
      <address>
        <city>Rio de janeiro</city>
        <zip>21550-013</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>October 30, 2012</study_first_submitted>
  <study_first_submitted_qc>November 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>October 21, 2014</last_update_submitted>
  <last_update_submitted_qc>October 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 23, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rio de Janeiro State University</investigator_affiliation>
    <investigator_full_name>Paula Morisco de Sá</investigator_full_name>
    <investigator_title>researcher</investigator_title>
  </responsible_party>
  <keyword>Silicosis</keyword>
  <keyword>forced oscillations</keyword>
  <keyword>respiratory mechanics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Silicosis</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/NCT01725971
org study id: Silicose2012
secondary id: Silicose2012
nct id: NCT01725971
lead sponsor: 
has dmc: No
Silicosis is a chronic and incurable occupational disease that can progress independent of
      the end of exposure. Recent works suggest that the Forced Oscillation Technique (FOT) may
      help to improve our understanding of the changes in lung mechanics, as well as in the
      detection of these changes.

      Objectives: Analyze the effects of airway obstruction in silicosis on the respiratory
      impedance and evaluated the diagnostic use of the FOT in these patients. For this, the
      investigators used spirometry to classify airway obstruction, which resulted in four
      categories: control, patients with normal exam, mild obstruction, and moderate-to-severe
      obstruction. Resistive data were interpreted using the zero-intercept resistance (R0), the
      resistance at 4 Hz (Rrs4) and the mean resistance (Rm). The investigators also analyzed the
      mean reactance (Xm) and the dynamic compliance (Crs,dyn). The total mechanical load was
      evaluated using the absolute value of the respiratory impedance (Z4Hz). The diagnostic
      potential was evaluated by investigating the area under the receiver operating characteristic
      curve (AUC).
time perspective: Cross-Sectional
measure: spirometric
time frame: 1 day
description: Spirometry was used to classify airway obstruction, which resulted in four categories: control (n=21), patients with normal exam (n=12), mild obstruction (n=22), and moderate-to-severe obstruction (n=12).
measure: Forced Oscillation technique
time frame: 1 day
description: In the analysis of the forced oscillation technique was used the following data: Resistive data were interpreted using the zero-intercept resistance (R0), the resistance at 4 Hz (Rrs4) and the mean resistance (Rm). The researchers also analyzed the mean reactance (Xm) and the dynamic compliance (Crs,dyn). The total mechanical load was evaluated using the absolute value of the respiratory impedance (Z4Hz).
arm group label: Control group
description: Group of nonsmokers individuals without respiratory disease.
arm group label: normal exam
description: subjects with silicosis , but with normal spirometric data
arm group label: mild obstruction
description: subjects with silicosis with mild obstruction in spirometric data
arm group label: moderate to severe obstruction
description: subjects with silicosis with moderate to severe obstruction in spirometric data
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Rio de Janeiro State University
investigator full name: Paula Morisco de Sá
investigator title: researcher
mesh term: Silicosis