<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/NCT03027180</url>
  </required_header>
  <id_info>
    <org_study_id>UNICID/CNPq 442709/2014-5</org_study_id>
    <nct_id>NCT03027180</nct_id>
  </id_info>
  <brief_title>Pressure Levels on Lung Expansion</brief_title>
  <official_title>DIFFERENT LEVELS OF NONINVASIVE POSITIVE AIRWAY PRESSURE FOR LUNG EXPANSION ON PATIENTS WITH PLEURAL DRAINAGE: A STUDY VIA COMPUTED TOMOGRAPHY</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Cidade de Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Cidade de Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Question: What level of noninvasive positive airway pressure is able to expand the lungs of&#xD;
      people with pleural drainage? Design: Cross-sectional, experimental and randomized study.&#xD;
      Participants: Four consecutive people with pleural effusion drained within 24 hours, with&#xD;
      controlled pain and without contraindications to use of noninvasive positive pressure.&#xD;
      Intervention: Each person will be randomly subjected to three levels of noninvasive positive&#xD;
      airway pressure: 0 (zero), 4 and 15 cmH2O for evaluation via chest computed tomography.&#xD;
      Outcome measures: Lung area.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lung area</measure>
    <time_frame>20 seconds after pressure application</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Pleural Effusion</condition>
  <arm_group>
    <arm_group_label>0 (zero) cmH2O</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>After draining, people will be asked about the level of pain via visual numeric scale and then subjected to chest computed tomography (Aquilion 64-Toshiba Medical Systems®, Japan), using positive airway pressure in the airways with 0 cmH2O</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4 cmH2O</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After draining, people will be asked about the level of pain via visual numeric scale and then subjected to chest computed tomography (Aquilion 64-Toshiba Medical Systems®, Japan), using positive airway pressure in the airways with 4 cmH2O</description>
  </arm_group>
  <arm_group>
    <arm_group_label>15 cmH2O</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>After draining, people will be asked about the level of pain via visual numeric scale and then subjected to chest computed tomography (Aquilion 64-Toshiba Medical Systems®, Japan), using positive airway pressure in the airways with 15 cmH2O</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Noninvasive positive airway pressure with different levels</intervention_name>
    <arm_group_label>0 (zero) cmH2O</arm_group_label>
    <arm_group_label>15 cmH2O</arm_group_label>
    <arm_group_label>4 cmH2O</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age over 18 years&#xD;
&#xD;
          -  presence of pleural drainage after traumatic hemothorax&#xD;
&#xD;
          -  thoracic drainage within 24 hours&#xD;
&#xD;
          -  controlled pain (below 3 points in the visual numeric scale, varying from zero to ten)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contraindication for use of noninvasive positive pressure in the airways, such as&#xD;
             reduced level of consciousness (drowsiness, agitation or confusion), use of vasoactive&#xD;
             drugs, complex arrhythmias, upper airway obstruction or trauma in the face, esophagus&#xD;
             or upper airway, ineffective cough, inability to swallow, distended abdomen, nausea,&#xD;
             vomiting, upper gastrointestinal bleeding&#xD;
&#xD;
          -  previous application of any sort of lung expansion technique after thoracic drainage.&#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>Adriana C Lunardi, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Cidade de São Paulo</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>January 20, 2017</last_update_submitted>
  <last_update_submitted_qc>January 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Cidade de Sao Paulo</investigator_affiliation>
    <investigator_full_name>Adriana Claudia Lunardi</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pleural Effusion</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03027180
org study id: UNICID/CNPq 442709/2014-5
nct id: NCT03027180
lead sponsor: 
has dmc: No
Question: What level of noninvasive positive airway pressure is able to expand the lungs of
      people with pleural drainage? Design: Cross-sectional, experimental and randomized study.
      Participants: Four consecutive people with pleural effusion drained within 24 hours, with
      controlled pain and without contraindications to use of noninvasive positive pressure.
      Intervention: Each person will be randomly subjected to three levels of noninvasive positive
      airway pressure: 0 (zero), 4 and 15 cmH2O for evaluation via chest computed tomography.
      Outcome measures: Lung area.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Lung area
time frame: 20 seconds after pressure application
arm group label: 0 (zero) cmH2O
arm group type: Active Comparator
description: After draining, people will be asked about the level of pain via visual numeric scale and then subjected to chest computed tomography (Aquilion 64-Toshiba Medical Systems®, Japan), using positive airway pressure in the airways with 0 cmH2O
arm group label: 4 cmH2O
arm group type: Experimental
description: After draining, people will be asked about the level of pain via visual numeric scale and then subjected to chest computed tomography (Aquilion 64-Toshiba Medical Systems®, Japan), using positive airway pressure in the airways with 4 cmH2O
arm group label: 15 cmH2O
arm group type: Experimental
description: After draining, people will be asked about the level of pain via visual numeric scale and then subjected to chest computed tomography (Aquilion 64-Toshiba Medical Systems®, Japan), using positive airway pressure in the airways with 15 cmH2O
intervention type: Device
intervention name: Noninvasive positive airway pressure with different levels
arm group label: 0 (zero) cmH2O
arm group label: 15 cmH2O
arm group label: 4 cmH2O
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Adriana C Lunardi, PhD
role: Principal Investigator
affiliation: Universidade Cidade de São Paulo
responsible party type: Principal Investigator
investigator affiliation: Universidade Cidade de Sao Paulo
investigator full name: Adriana Claudia Lunardi
investigator title: Professor
mesh term: Pleural Effusion
sharing ipd: No