<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/NCT02196870</url>
  </required_header>
  <id_info>
    <org_study_id>Chest wall Elastance in ARF</org_study_id>
    <nct_id>NCT02196870</nct_id>
  </id_info>
  <brief_title>Effects of Chest Wall Elastance on Pulmonary Mechanics of Acute Respiratory Failure (ARF)</brief_title>
  <official_title>Physiological Effects of Chest Wall Elastance on Pulmonary Mechanics of Acute Respiratory Failure Patientstranspulmonary Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southeast University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southeast University, China</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with chest wall elastance increasing could worsen lung function. Increasing of chest&#xD;
      wall elastance plays a great role in lung mechanics, and could influence mechanical&#xD;
      ventilation settings. Therefore, It could help the physicians to find appropriate indicators&#xD;
      and optimize the treatments of ARF patients to explore the mechanisms of lung mechanics&#xD;
      changse in the patients with high chest wall elastance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mechanical ventilation(MV) is an important treatment for acute respiratory failure(ARF)&#xD;
      patients, could improve hypoxemia, maintain lung volume and promote alveolar opening.&#xD;
      However, because of barotrauma, volutrauma and biotrauma, MV could cause or aggravate acute&#xD;
      lung injury not only in acute respiratory distress syndrome(ARDS) patients, but in patients&#xD;
      with normal lung function1,2.&#xD;
&#xD;
      Patients with chest wall elastance increasing could worsen lung function. Increasing of chest&#xD;
      wall elastance plays a great role in lung mechanics, and could influence mechanical&#xD;
      ventilation settings. Therefore, It could help the physicians to find appropriate indicators&#xD;
      and optimize the treatments of ARF patients to explore the mechanisms of lung mechanics&#xD;
      changse in the patients with high chest wall elastance.&#xD;
&#xD;
      The present study is set out to examine the effects of high chest wall elastance on changes&#xD;
      of lung mechanics and the correlation of airway pressure(Paw) stress index and transpulmonary&#xD;
      pressure(PL) stress index.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Changes of oxygenation and lung mechanics</measure>
    <time_frame>up to 24 months</time_frame>
  </primary_outcome>
  <enrollment type="Actual">12</enrollment>
  <condition>Airway Pressure Stress Index</condition>
  <condition>Transpulmonary Pressure Stress Index</condition>
  <condition>Acute Respiratory Failure</condition>
  <condition>Chest Wall Elastance</condition>
  <eligibility>
    <study_pop>
      <textblock>
        acute respiratory failure patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ARF&#xD;
&#xD;
          -  mechanical ventilation&#xD;
&#xD;
          -  cardiovascular stable&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt; 18y or &gt; 85y&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  COPD or chronic pulmonary disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianfeng Xie, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zhongda hospital, Southeast University, Jiangsu, China</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhongda Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>July 12, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>June 23, 2015</last_update_submitted>
  <last_update_submitted_qc>June 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Jianfeng Xie</investigator_full_name>
    <investigator_title>Department of Critical Care Medicine, Zhong-Da Hospital</investigator_title>
  </responsible_party>
  <keyword>Airway pressure stress index</keyword>
  <keyword>Transpulmonary pressure stress index</keyword>
  <keyword>Acute Respiratory Failure</keyword>
  <keyword>Chest wall elastance</keyword>
  <keyword>Lung stress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</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/NCT02196870
org study id: Chest wall Elastance in ARF
nct id: NCT02196870
lead sponsor: 
has dmc: Yes
Patients with chest wall elastance increasing could worsen lung function. Increasing of chest
      wall elastance plays a great role in lung mechanics, and could influence mechanical
      ventilation settings. Therefore, It could help the physicians to find appropriate indicators
      and optimize the treatments of ARF patients to explore the mechanisms of lung mechanics
      changse in the patients with high chest wall elastance.
Mechanical ventilation(MV) is an important treatment for acute respiratory failure(ARF)
      patients, could improve hypoxemia, maintain lung volume and promote alveolar opening.
      However, because of barotrauma, volutrauma and biotrauma, MV could cause or aggravate acute
      lung injury not only in acute respiratory distress syndrome(ARDS) patients, but in patients
      with normal lung function1,2.

      Patients with chest wall elastance increasing could worsen lung function. Increasing of chest
      wall elastance plays a great role in lung mechanics, and could influence mechanical
      ventilation settings. Therefore, It could help the physicians to find appropriate indicators
      and optimize the treatments of ARF patients to explore the mechanisms of lung mechanics
      changse in the patients with high chest wall elastance.

      The present study is set out to examine the effects of high chest wall elastance on changes
      of lung mechanics and the correlation of airway pressure(Paw) stress index and transpulmonary
      pressure(PL) stress index.
observational model: Case-Control
time perspective: Prospective
measure: Changes of oxygenation and lung mechanics
time frame: up to 24 months
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Jianfeng Xie, Dr.
role: Principal Investigator
affiliation: Zhongda hospital, Southeast University, Jiangsu, China
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Southeast University, China
investigator full name: Jianfeng Xie
investigator title: Department of Critical Care Medicine, Zhong-Da Hospital
mesh term: Respiratory Insufficiency
mesh term: Respiratory Distress Syndrome