<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/NCT03763890</url>
  </required_header>
  <id_info>
    <org_study_id>20181129PEEP</org_study_id>
    <nct_id>NCT03763890</nct_id>
  </id_info>
  <brief_title>Post- End- Expiratory Pressure Affect the Alveolar Heterogeneity in Moderate and Sever ARDS Patients</brief_title>
  <official_title>Post- End- Expiratory Pressure Affect the Alveolar Heterogeneity in Moderate and Sever ARDS Patients</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study try to use EIT ( Electronic impedance tomography ) to evaluate the alveolar&#xD;
      heterogeneity and use trans-pulmonary pressure and stain to evaluate the lung injury . The&#xD;
      study use these methods to figure out how PEEP impact the alveolar heterogeneity and VILI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ARDS(Acute respiratory distress syndrome )is common in patients suffering Sepsis, trauma,&#xD;
      burning and other sever condition and characterized by diffuse alveolar damage and alveolar&#xD;
      heterogeneity.ARDS patient need MV(mechanical ventilation )to maintain oxygenation and need&#xD;
      unique MV tragedy to avoid VILI(Ventilator induced Lung injury ).PEEP(post-end-expiratory&#xD;
      pressure) is crucial to maintain oxygenation and avoid VILI according to researches. But&#xD;
      there are also some other research different voice. This study try to use EIT ( Electronic&#xD;
      impedance tomography ) to evaluate the alveolar heterogeneity and use trans-pulmonary&#xD;
      pressure and stain to evaluate the lung injury . The study use these methods to figure out&#xD;
      how PEEP impact the alveolar heterogeneity and VILI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Anticipated">December 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>alveolar hyper-distention; alveolar collapse；alveolar opening and closing；</measure>
    <time_frame>September,1,2018-December 30, 2020</time_frame>
    <description>The study use Pulmo Vista 500 device (Drager co.),is intended to perform thoracic bioimpedance measurements by applying the technique of electrical impedance tomography (EIT)to evaluate alveolar hyper-distention(%of the lung volume); alveolar collapse(% of the lung volume)；alveolar opening and closing(% of the lung volume).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trans-pulmonary pressure</measure>
    <time_frame>September,1,2018-December 30, 2020</time_frame>
    <description>The researchers place tube in the esophagus and connect it to transmitter to measure esophageal pressure (mmHg)and calculate trans-pulmonary pressure(mmHg) to evaluate stress</description>
  </primary_outcome>
  <primary_outcome>
    <measure>EELV</measure>
    <time_frame>September,1,2018-December 30, 2020</time_frame>
    <description>The research use nitrogen wash out to measure EELV（end-expiratory lung volume, ml） to calculate dynamic strain and evaluate the strain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>peak pressure</measure>
    <time_frame>September,1,2018-December 30, 2020</time_frame>
    <description>The researchers use ventilator to measure peak pressure(cmH2O) in patients with mechanical ventilation and without spontaneous breathing..</description>
  </primary_outcome>
  <primary_outcome>
    <measure>plateau pressure</measure>
    <time_frame>September,1,2018-December 30, 2020</time_frame>
    <description>The researchers use ventilator to do inspiration pause to measure plateau pressure(cmH2O) in patients with mechanical ventilation and without spontaneous breathing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>tidal volume</measure>
    <time_frame>September,1,2018-December 30, 2020</time_frame>
    <description>The researchers use ventilator to measure tidal volume(ml) in patients with mechanical ventilation and without spontaneous breathing..</description>
  </primary_outcome>
  <primary_outcome>
    <measure>respiratory rate</measure>
    <time_frame>September,1,2018-December 30, 2020</time_frame>
    <description>The researchers record the set respiratory rate(bpm) in patients with mechanical ventilation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>flow</measure>
    <time_frame>September,1,2018-December 30, 2020</time_frame>
    <description>The researchers record the set Flow (L/min) in patients with mechanical ventilation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FiO2</measure>
    <time_frame>September,1,2018-December 30, 2020</time_frame>
    <description>The researchers record the set FiO2 ( fraction of inspiratory oxygen, %) in patients with mechanical ventilation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PaO2</measure>
    <time_frame>September,1,2018-December 30, 2020</time_frame>
    <description>The researchers use blood gas analysis to measure PaO2( arterial oxygen pressure,mmHg)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PaCO2</measure>
    <time_frame>September,1,2018-December 30, 2020</time_frame>
    <description>The researchers use blood gas analysis to measure PaCO2( arterial carbon dioxide pressure,mmHg) .</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SBP</measure>
    <time_frame>September,1,2018-December 30, 2020</time_frame>
    <description>Recording SBP(systolic pressure, mmHg),which is always continuously monitored with invasive pressure monitor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DBP</measure>
    <time_frame>September,1,2018-December 30, 2020</time_frame>
    <description>Recording DBP(Diastolic pressure, mmHg),which is always continuously monitored with invasive pressure monitor.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVP</measure>
    <time_frame>September,1,2018-December 30, 2020</time_frame>
    <description>Recording CVP(central venous Pressure）,which is always discontinuously monitored with jugular pressure monitor mmHg).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>vasopressor</measure>
    <time_frame>September,1,2018-December 30, 2020</time_frame>
    <description>Recording clinical vasopressor usage including Norepinephrine（ μg/Kg/min;）Epinephrine（μg/Kg/min） Dobutamine （ μg/Kg/min)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Ards</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Post-end-Expiratory pressure</intervention_name>
    <description>Titrate the PEEP from 24 cmH2O to 6 cmH2O, 2 cmH2O/step and record EIT, trans-pulmonary pressure, hemodynamic parameter and Blood-gas analysis.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Moderate or sever ARDS in 2012 &lt;Berlin definition&gt;;&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age≥18 or&lt;80；&#xD;
&#xD;
          2. Moderate or sever ARDS in 2012 &lt;Berlin definition&gt;;&#xD;
&#xD;
          3. Applied mechanical ventilation;&#xD;
&#xD;
          4. Consent signed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Asthma or COPD；&#xD;
&#xD;
          2. Cardiogenic edema；&#xD;
&#xD;
          3. Sever neutropenia(&lt;500/mm3)；&#xD;
&#xD;
          4. Hemodynamic astatic: DOPA or Dobutamine &gt;15 µg/kg/ min; NE &gt; 15ug /min；&#xD;
&#xD;
          5. GCS coma score ≤12；&#xD;
&#xD;
          6. Thoracic injury or surgery patients contradict EIT ；&#xD;
&#xD;
          7. Refuse to join in trail；&#xD;
&#xD;
          8. Included in other clinical trail。&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>haibo qiu, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>ling Liu, Phd</last_name>
    <phone>13851435472</phone>
    <email>liulingdoctor@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>haibo qiu, PhD</last_name>
    <phone>13951965301</phone>
    <phone_ext>professor</phone_ext>
    <email>haiboq@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Nanjing Zhong-Da Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ling Liu, MD.</last_name>
      <phone>86-25-83272201</phone>
      <email>liulingdoctor@126.com</email>
    </contact>
    <contact_backup>
      <last_name>Haibo Qiu, PhD.,MD.</last_name>
      <phone>86-25-83272200</phone>
      <email>haiboq2000@yahoo.com.cn</email>
    </contact_backup>
    <investigator>
      <last_name>ling Liu, Phd</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>July 17, 2022</last_update_submitted>
  <last_update_submitted_qc>July 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Ling Liu</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <keyword>ARDS（Acute respiratory syndrome）;</keyword>
  <keyword>stress;</keyword>
  <keyword>strain;</keyword>
  <keyword>Trans-pulmonary pressure;</keyword>
  <keyword>FRC(functional residual capacity )</keyword>
  <keyword>PEEP（post end-expiratory pressure）;</keyword>
  <keyword>EIT（Electronic impedance tomography）;</keyword>
  <keyword>RVD(region ventilation delay)</keyword>
  <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/NCT03763890
org study id: 20181129PEEP
nct id: NCT03763890
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study try to use EIT ( Electronic impedance tomography ) to evaluate the alveolar
      heterogeneity and use trans-pulmonary pressure and stain to evaluate the lung injury . The
      study use these methods to figure out how PEEP impact the alveolar heterogeneity and VILI.
ARDS(Acute respiratory distress syndrome )is common in patients suffering Sepsis, trauma,
      burning and other sever condition and characterized by diffuse alveolar damage and alveolar
      heterogeneity.ARDS patient need MV(mechanical ventilation )to maintain oxygenation and need
      unique MV tragedy to avoid VILI(Ventilator induced Lung injury ).PEEP(post-end-expiratory
      pressure) is crucial to maintain oxygenation and avoid VILI according to researches. But
      there are also some other research different voice. This study try to use EIT ( Electronic
      impedance tomography ) to evaluate the alveolar heterogeneity and use trans-pulmonary
      pressure and stain to evaluate the lung injury . The study use these methods to figure out
      how PEEP impact the alveolar heterogeneity and VILI.
observational model: Case-Crossover
time perspective: Prospective
measure: alveolar hyper-distention; alveolar collapse；alveolar opening and closing；
time frame: September,1,2018-December 30, 2020
description: The study use Pulmo Vista 500 device (Drager co.),is intended to perform thoracic bioimpedance measurements by applying the technique of electrical impedance tomography (EIT)to evaluate alveolar hyper-distention(%of the lung volume); alveolar collapse(% of the lung volume)；alveolar opening and closing(% of the lung volume).
measure: Trans-pulmonary pressure
time frame: September,1,2018-December 30, 2020
description: The researchers place tube in the esophagus and connect it to transmitter to measure esophageal pressure (mmHg)and calculate trans-pulmonary pressure(mmHg) to evaluate stress
measure: EELV
time frame: September,1,2018-December 30, 2020
description: The research use nitrogen wash out to measure EELV（end-expiratory lung volume, ml） to calculate dynamic strain and evaluate the strain
measure: peak pressure
time frame: September,1,2018-December 30, 2020
description: The researchers use ventilator to measure peak pressure(cmH2O) in patients with mechanical ventilation and without spontaneous breathing..
measure: plateau pressure
time frame: September,1,2018-December 30, 2020
description: The researchers use ventilator to do inspiration pause to measure plateau pressure(cmH2O) in patients with mechanical ventilation and without spontaneous breathing.
measure: tidal volume
time frame: September,1,2018-December 30, 2020
description: The researchers use ventilator to measure tidal volume(ml) in patients with mechanical ventilation and without spontaneous breathing..
measure: respiratory rate
time frame: September,1,2018-December 30, 2020
description: The researchers record the set respiratory rate(bpm) in patients with mechanical ventilation.
measure: flow
time frame: September,1,2018-December 30, 2020
description: The researchers record the set Flow (L/min) in patients with mechanical ventilation.
measure: FiO2
time frame: September,1,2018-December 30, 2020
description: The researchers record the set FiO2 ( fraction of inspiratory oxygen, %) in patients with mechanical ventilation.
measure: PaO2
time frame: September,1,2018-December 30, 2020
description: The researchers use blood gas analysis to measure PaO2( arterial oxygen pressure,mmHg)
measure: PaCO2
time frame: September,1,2018-December 30, 2020
description: The researchers use blood gas analysis to measure PaCO2( arterial carbon dioxide pressure,mmHg) .
measure: SBP
time frame: September,1,2018-December 30, 2020
description: Recording SBP(systolic pressure, mmHg),which is always continuously monitored with invasive pressure monitor.
measure: DBP
time frame: September,1,2018-December 30, 2020
description: Recording DBP(Diastolic pressure, mmHg),which is always continuously monitored with invasive pressure monitor.
measure: CVP
time frame: September,1,2018-December 30, 2020
description: Recording CVP(central venous Pressure）,which is always discontinuously monitored with jugular pressure monitor mmHg).
measure: vasopressor
time frame: September,1,2018-December 30, 2020
description: Recording clinical vasopressor usage including Norepinephrine（ μg/Kg/min;）Epinephrine（μg/Kg/min） Dobutamine （ μg/Kg/min)
intervention type: Device
intervention name: Post-end-Expiratory pressure
description: Titrate the PEEP from 24 cmH2O to 6 cmH2O, 2 cmH2O/step and record EIT, trans-pulmonary pressure, hemodynamic parameter and Blood-gas analysis.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: haibo qiu, PhD
role: Study Director
affiliation: Nanjing Zhong-Da Hospital, Southeast University School of Medicine,China
last name: ling Liu, Phd
phone: 13851435472
email: liulingdoctor@126.com
last name: haibo qiu, PhD
phone: 13951965301
phone ext: professor
email: haiboq@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Southeast University, China
investigator full name: Ling Liu
investigator title: Director
sharing ipd: No