<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/NCT03237806</url>
  </required_header>
  <id_info>
    <org_study_id>2012ZDIIKY22.0</org_study_id>
    <nct_id>NCT03237806</nct_id>
  </id_info>
  <brief_title>Effects of Sedation on Transpulmonary Pressure and Lung Homogenous</brief_title>
  <acronym>ARDS</acronym>
  <official_title>Effects of Sedation on Transpulmonary Pressure and Lung Homogenous of 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The acute respiratory distress syndrome (ARDS) is characterized by severe respiratory&#xD;
      failure. Open Lung and Lung Protective Strategy have been proved to improve mortality of ARDS&#xD;
      patients. Preserving spontaneous breathing (SB) is good for inflating the lung lobe near&#xD;
      diaphram during mechanical ventilation, however, strong respiratory drive could generate more&#xD;
      transpulmonary pressure in ARDS patients, which increase the stress and strain in injured&#xD;
      lung. Nonetheless, it's not clear if sedative has any effects on transpulmonary pressure of&#xD;
      ARDS patients.The purpose of this study is to investigate the effects of sedation on&#xD;
      transpulmonary pressure of ARDS patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Further study details as provided by Nanjing Zhong-da Hospital, School of Medicine, Southeast&#xD;
      University&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 31, 2015</start_date>
  <completion_date type="Actual">March 18, 2018</completion_date>
  <primary_completion_date type="Actual">January 18, 2018</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>
    <intervention_model_description>Self control</intervention_model_description>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>No Masking</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Transpulmonary pressure generate by patient during deep or light sedation</measure>
    <time_frame>15 minutes during deep or light sedation</time_frame>
    <description>Ispiratory transpulmonary pressure and expiratory transpulmonary pressure measured during sedation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>static compliance of respiratory system</measure>
    <time_frame>15min during deep or light sedation</time_frame>
    <description>Crs measured during deep or light sedation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PaO2</measure>
    <time_frame>15 minutes</time_frame>
    <description>ABG after deep or light sedation</description>
  </secondary_outcome>
  <other_outcome>
    <measure>MAP</measure>
    <time_frame>15 minutes</time_frame>
    <description>MAP during deep or light sedation</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>ARDS</condition>
  <arm_group>
    <arm_group_label>Baseline</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>In this phase, patients were sedated to the level of Ramsay 6 before Deep sedated or Light sedated</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Deep sedation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this Arm, patients were sedated to the level of Ramsay 5(Deep sedated) by Midazolam IV continuously</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Light sedation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this Arm, patients were sedated to the level of Ramsay 3(Light sedated)by Midazolam IV continuously</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Deep sedated</intervention_name>
    <description>Midazolam intravenous continusly infusion, Deep sedated (Ramsay 5)</description>
    <arm_group_label>Deep sedation</arm_group_label>
    <other_name>Deep sedation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Light sedated</intervention_name>
    <description>Midazolam intravenous continusly infusion, Light sedated (Ramsay 3)</description>
    <arm_group_label>Light sedation</arm_group_label>
    <other_name>Light sedation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. ARDS group patient (1) Acute onset of all of the following criteria within a 48-hour&#xD;
             period:&#xD;
&#xD;
               1. Requires positive pressure ventilation through an endotracheal tube&#xD;
&#xD;
               2. Bilateral infiltrates consistent with edema on frontal chest radiograph, with a&#xD;
                  duration of no more than 7 days&#xD;
&#xD;
               3. PaO2/FiO2 less than 300 while receiving positive end-expiratory pressure (PEEP)&#xD;
                  at more than 5 cm H2O for at least 4 hours, with a duration of no more than 7&#xD;
                  days&#xD;
&#xD;
               4. No clinical evidence of left atrial hypertension (2) Hemodynamics stable&#xD;
                  (dopamine &lt;10ug/kg•min or norepinephrine &lt;10ug/kg)&#xD;
&#xD;
          2. Surgical patient Surgical patient requires positive pressure ventilation through an&#xD;
             endotracheal tube PaO2/FiO2 more than 300 Hemodynamics stable (dopamine &lt;10ug/kg•min&#xD;
             or norepinephrine &lt;10ug/kg)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age younger than 18 years or older than 85 years&#xD;
&#xD;
          -  Cardiac failure&#xD;
&#xD;
          -  Known pregnancy&#xD;
&#xD;
          -  Increased intracranial pressure&#xD;
&#xD;
          -  Severe neuromuscular disease&#xD;
&#xD;
          -  Recent injury or other pathologic condition of the esophagus&#xD;
&#xD;
          -  Pneumothorax&#xD;
&#xD;
          -  Pleural effusion&#xD;
&#xD;
          -  Diaphragmatic hernia&#xD;
&#xD;
          -  Severe chronic respiratory disease&#xD;
&#xD;
          -  End-stage chronic organ failure&#xD;
&#xD;
          -  Expected survival of less than 24 hours&#xD;
&#xD;
          -  Participation in another interventional study&#xD;
&#xD;
          -  Attending physician declines to give consent for participant to enroll&#xD;
&#xD;
          -  Patient or surrogate declines or is unable to give consent&#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>Songqiao Liu, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University</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>March 2018</verification_date>
  <study_first_submitted>May 21, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>March 18, 2018</last_update_submitted>
  <last_update_submitted_qc>March 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Songqiao Liu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>ARDS,</keyword>
  <keyword>Transpulmonary pressure,</keyword>
  <keyword>Sedation</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/NCT03237806
org study id: 2012ZDIIKY22.0
nct id: NCT03237806
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The acute respiratory distress syndrome (ARDS) is characterized by severe respiratory
      failure. Open Lung and Lung Protective Strategy have been proved to improve mortality of ARDS
      patients. Preserving spontaneous breathing (SB) is good for inflating the lung lobe near
      diaphram during mechanical ventilation, however, strong respiratory drive could generate more
      transpulmonary pressure in ARDS patients, which increase the stress and strain in injured
      lung. Nonetheless, it's not clear if sedative has any effects on transpulmonary pressure of
      ARDS patients.The purpose of this study is to investigate the effects of sedation on
      transpulmonary pressure of ARDS patients.
Further study details as provided by Nanjing Zhong-da Hospital, School of Medicine, Southeast
      University
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Self control
primary purpose: Screening
masking: None (Open Label)
masking description: No Masking
measure: Transpulmonary pressure generate by patient during deep or light sedation
time frame: 15 minutes during deep or light sedation
description: Ispiratory transpulmonary pressure and expiratory transpulmonary pressure measured during sedation
measure: static compliance of respiratory system
time frame: 15min during deep or light sedation
description: Crs measured during deep or light sedation
measure: PaO2
time frame: 15 minutes
description: ABG after deep or light sedation
measure: MAP
time frame: 15 minutes
description: MAP during deep or light sedation
arm group label: Baseline
arm group type: No Intervention
description: In this phase, patients were sedated to the level of Ramsay 6 before Deep sedated or Light sedated
arm group label: Deep sedation
arm group type: Experimental
description: In this Arm, patients were sedated to the level of Ramsay 5(Deep sedated) by Midazolam IV continuously
arm group label: Light sedation
arm group type: Experimental
description: In this Arm, patients were sedated to the level of Ramsay 3(Light sedated)by Midazolam IV continuously
intervention type: Drug
intervention name: Deep sedated
description: Midazolam intravenous continusly infusion, Deep sedated (Ramsay 5)
arm group label: Deep sedation
other name: Deep sedation
intervention type: Drug
intervention name: Light sedated
description: Midazolam intravenous continusly infusion, Light sedated (Ramsay 3)
arm group label: Light sedation
other name: Light sedation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Songqiao Liu, Doctor
role: Principal Investigator
affiliation: Department of Critical Care Medicine, Nanjing Zhong-da Hospital, School of Medicine, Southeast University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Southeast University, China
investigator full name: Songqiao Liu
investigator title: Principal Investigator
sharing ipd: No