<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/NCT03241654</url>
  </required_header>
  <id_info>
    <org_study_id>KY-2017-001</org_study_id>
    <nct_id>NCT03241654</nct_id>
  </id_info>
  <brief_title>Decreasing Trigger Sensitivity Could Assist PEEP to Further Improve Regional Ventilation Distribution</brief_title>
  <official_title>Decreasing Trigger Sensitivity Could Assist PEEP to Further Improve Regional Aeration and Homogeneity During Pressure Assist Ventilation: A Preliminarily Physiological Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Capital Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Capital Medical University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In mechanically ventilated patients during supine position, alveolar collapse usually&#xD;
      distributes in dependent lung region.Decrease of flow trigger sensitivity might improve&#xD;
      homogeneous of tidal volume distribution.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In mechanically ventilated patients during supine position, alveolar collapse usually&#xD;
      distributes in dependent lung region. High positive end expiratory pressure (PEEP) has been&#xD;
      applied to improve the homogeneous distribution of ventilation by increasing the end&#xD;
      expiratory lung ventilation (EELV) and alveolar recruitment. However, for patients who&#xD;
      increasing PEEP in some extent still existed poor aeration in the dependent region, further&#xD;
      elevating PEEP seems to be unreasonable that perhaps lead to overdistension. Decreasing&#xD;
      trigger sensitivity might further evoke inspiratory efforts to improve the ventilation for&#xD;
      this type of patients.The Electrical impedance tomography (EIT) was applied in monitoring the&#xD;
      regional ventilation distribution at the bedside.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Actual">February 1, 2018</completion_date>
  <primary_completion_date type="Actual">August 20, 2017</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>The homogeneity of distribution of tidal volume</measure>
    <time_frame>within 20 minutes after changing flow trigger</time_frame>
    <description>EIT was used to monitoring the homogeneity of distribution of tidal volume that was divided into two contiguous regions of interest (ROI) equally, the dependent and non-dependent area. The ratio of relative distribution of tidal ventilation of two ROI was calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in global and regional EELV</measure>
    <time_frame>within 20 minutes after changing flow trigger</time_frame>
    <description>The change of EELV was measured after changing flow trigger based on the baseline level.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Mechanical Ventilation</condition>
  <arm_group>
    <arm_group_label>the lowest trigger sensitivity</arm_group_label>
    <description>The flow trigger of ventilator was set as the lowest level of sensitivity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>the highest trigger sensitivity</arm_group_label>
    <description>The flow trigger of ventilator was set as the highest level of sensitivity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>flow trigger</intervention_name>
    <description>The flow trigger will be adjust during the pressure assist ventilation.</description>
    <arm_group_label>the highest trigger sensitivity</arm_group_label>
    <arm_group_label>the lowest trigger sensitivity</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The postoperative patients receiving pressure support ventilation and existing heterogenous&#xD;
        ventilation.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The post operative patients who received pressure support ventilation;&#xD;
&#xD;
          2. After the clinical PEEP was evaluated 5cmH2O, the tidal volume distribution still&#xD;
             existed heterogeneity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Under 18 years;&#xD;
&#xD;
          2. History of diaphragm dysfunction and surgery;&#xD;
&#xD;
          3. Central respiratory drive dysfunction;&#xD;
&#xD;
          4. history of esophageal, gastric or lung surgery;&#xD;
&#xD;
          5. The contraindication of using EIT (pacemaker, defibrillator, and implantable pumps).&#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>Jian-Xin Zhou, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Tiantan Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jian-Xin Zhou</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2017</study_first_posted>
  <last_update_submitted>February 9, 2018</last_update_submitted>
  <last_update_submitted_qc>February 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Capital Medical University</investigator_affiliation>
    <investigator_full_name>Jian-Xin Zhou</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>Hypersensitivity</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/NCT03241654
org study id: KY-2017-001
nct id: NCT03241654
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In mechanically ventilated patients during supine position, alveolar collapse usually
      distributes in dependent lung region.Decrease of flow trigger sensitivity might improve
      homogeneous of tidal volume distribution.
In mechanically ventilated patients during supine position, alveolar collapse usually
      distributes in dependent lung region. High positive end expiratory pressure (PEEP) has been
      applied to improve the homogeneous distribution of ventilation by increasing the end
      expiratory lung ventilation (EELV) and alveolar recruitment. However, for patients who
      increasing PEEP in some extent still existed poor aeration in the dependent region, further
      elevating PEEP seems to be unreasonable that perhaps lead to overdistension. Decreasing
      trigger sensitivity might further evoke inspiratory efforts to improve the ventilation for
      this type of patients.The Electrical impedance tomography (EIT) was applied in monitoring the
      regional ventilation distribution at the bedside.
observational model: Case-Crossover
time perspective: Prospective
measure: The homogeneity of distribution of tidal volume
time frame: within 20 minutes after changing flow trigger
description: EIT was used to monitoring the homogeneity of distribution of tidal volume that was divided into two contiguous regions of interest (ROI) equally, the dependent and non-dependent area. The ratio of relative distribution of tidal ventilation of two ROI was calculated.
measure: Changes in global and regional EELV
time frame: within 20 minutes after changing flow trigger
description: The change of EELV was measured after changing flow trigger based on the baseline level.
arm group label: the lowest trigger sensitivity
description: The flow trigger of ventilator was set as the lowest level of sensitivity.
arm group label: the highest trigger sensitivity
description: The flow trigger of ventilator was set as the highest level of sensitivity.
intervention type: Procedure
intervention name: flow trigger
description: The flow trigger will be adjust during the pressure assist ventilation.
arm group label: the highest trigger sensitivity
arm group label: the lowest trigger sensitivity
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jian-Xin Zhou, MD
role: Principal Investigator
affiliation: Beijing Tiantan Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Jian-Xin Zhou
investigator title: Professor
mesh term: Hypersensitivity