<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/NCT03830099</url>
  </required_header>
  <id_info>
    <org_study_id>KY 2018-006-01</org_study_id>
    <nct_id>NCT03830099</nct_id>
  </id_info>
  <brief_title>Inhomogeneous Ventilation in Adult Post-neurosurgical Patients</brief_title>
  <official_title>Inhomogeneous Ventilation in Adult Post-neurosurgical Patients: an Observational 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>
    <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>
      Inhomogeneous ventilation was more likely to happen in patients after general anesthesia.&#xD;
      Inhomogeneous ventilation may associate with ventilator-induced lung injury. A large number&#xD;
      of post-neurosurgical patients was delayed extubation and received mechanical ventilation, so&#xD;
      that, inhomogeneous ventilation was more likely to happen in the population. Electrical&#xD;
      impedance tomography (EIT) is an noninvasive, radiation-free, high temporal resolution,&#xD;
      relatively cheap technique in monitoring ventilation distribution bedside. The investigators&#xD;
      aimed to investigate the incidence of inhomogeneous ventilation and factors associated with&#xD;
      inhomogeneous ventilation in post-neurosurgical patients under mechanical ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Inhomogeneous ventilation was more likely to happen in patients after general anesthesia.&#xD;
      Inhomogeneous ventilation may associate with ventilator-induced lung injury since the&#xD;
      gravity-depend collapse and over-distention of nondependent regional in patients under&#xD;
      mechanical ventilation. A large number of post-neurosurgical patients was delayed extubation&#xD;
      and received mechanical ventilation, so that, inhomogeneous ventilation was more likely to&#xD;
      happen in the population. Up to now, there is no research reported about the prevalence of&#xD;
      inhomogeneous ventilation and the factors associated with inhomogeneous ventilation in&#xD;
      post-neurosurgical patients, in present study, The investigators prospectively enrolled adult&#xD;
      patients after neurosurgical operations. Electrical impedance tomography (EIT) is an&#xD;
      noninvasive, radiation-free, high temporal resolution, relatively cheap technique in&#xD;
      monitoring ventilation distribution bedside. The investigators aimed to investigate the&#xD;
      incidence of inhomogeneous ventilation and factors associated with inhomogeneous ventilation&#xD;
      in post-neurosurgical patients under mechanical ventilation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Anticipated">August 31, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of inhomogeneous ventilation</measure>
    <time_frame>within 24 hours after neurosurgical operative</time_frame>
    <description>In supine position, global image of EIT was divided into upper and lower part, each part accounting for 50%, which was named as non-dependent region and dependent region respectively. Inhomogeneous ventilation was defined as the ratio between tidal impedance variation of dependent region(VTdep) and global tidal impedance variation (VT) is less than 45% during stable Spontaneous breath, which was defined as variation of tidal volume less than 10% in continuous 6 breathes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The incidence of postoperative pulmonary complications(PPCs)</measure>
    <time_frame>28 days after neurosurgical operative</time_frame>
    <description>Postoperative pulmonary complication was defined as follows: Pneumonia was defined as recent pulmonary infiltration on chest radiography associated with at least 2 of the following signs: purulent tracheobronchial secretion, a body temperature &gt; 38.3℃，and leukocytes in peripheral blood &gt; 25% above the basal count. Tracheobronchitis was an increase in the volume or a change in the color or purulent aspect of tracheobronchial secretion with a normal chest radiograph. Atelectasis was evidence on chest radiography of pulmonary atelectasis associated with acute respiratory symptoms. Bronchoconstriction was classified as the presence of wheezing associated with acute respiratory symptoms with a good response to inhalatory bronchodilator medication.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of ICU stay</measure>
    <time_frame>through study completion, an average of 7 days</time_frame>
    <description>The number of days that patients stay in ICU.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>through study completion, an average of 28 days</time_frame>
    <description>The number of days that patients stay in hospital.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Mechanical Ventilation</condition>
  <condition>Electrical Impedance Tomography</condition>
  <condition>Inhomogeneous Ventilation</condition>
  <condition>Neurosurgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult post-neurosurgical patients under mechanical ventilation(MV).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing elective neurosurgery operation&#xD;
&#xD;
          -  Trachea intubated and mechanical ventilated&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age under 18 years-old&#xD;
&#xD;
          -  Unstable hemodynamics patients (mean arterial pressure under 65mmHg) after&#xD;
             pharmacotherapy&#xD;
&#xD;
          -  History of chronic obstructive pulmonary disease(COPD) or asthma&#xD;
&#xD;
          -  Contraindication of using EIT (pacemaker, defibrillator, and implantable pumps)&#xD;
&#xD;
          -  Unable to install EIT belt (skin infection, wound)&#xD;
&#xD;
          -  Incompleteness of thorax (e.g. pneumothorax, rib fracture and etc.) or malformation of&#xD;
             thorax.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Gender was based on basic information collected at the moment when patients was admitted to hospital.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</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>
  <overall_contact>
    <last_name>Jian-Xin Zhou, MD</last_name>
    <phone>8610 67096579</phone>
    <email>zhoujx.cn@icloud.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>ICU, Beijing Tiantan Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jian-Xin Zhou, MD</last_name>
      <email>zhoujx.cn@icloud.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>February 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</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>
  <!-- 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/NCT03830099
org study id: KY 2018-006-01
nct id: NCT03830099
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Inhomogeneous ventilation was more likely to happen in patients after general anesthesia.
      Inhomogeneous ventilation may associate with ventilator-induced lung injury. A large number
      of post-neurosurgical patients was delayed extubation and received mechanical ventilation, so
      that, inhomogeneous ventilation was more likely to happen in the population. Electrical
      impedance tomography (EIT) is an noninvasive, radiation-free, high temporal resolution,
      relatively cheap technique in monitoring ventilation distribution bedside. The investigators
      aimed to investigate the incidence of inhomogeneous ventilation and factors associated with
      inhomogeneous ventilation in post-neurosurgical patients under mechanical ventilation.
Inhomogeneous ventilation was more likely to happen in patients after general anesthesia.
      Inhomogeneous ventilation may associate with ventilator-induced lung injury since the
      gravity-depend collapse and over-distention of nondependent regional in patients under
      mechanical ventilation. A large number of post-neurosurgical patients was delayed extubation
      and received mechanical ventilation, so that, inhomogeneous ventilation was more likely to
      happen in the population. Up to now, there is no research reported about the prevalence of
      inhomogeneous ventilation and the factors associated with inhomogeneous ventilation in
      post-neurosurgical patients, in present study, The investigators prospectively enrolled adult
      patients after neurosurgical operations. Electrical impedance tomography (EIT) is an
      noninvasive, radiation-free, high temporal resolution, relatively cheap technique in
      monitoring ventilation distribution bedside. The investigators aimed to investigate the
      incidence of inhomogeneous ventilation and factors associated with inhomogeneous ventilation
      in post-neurosurgical patients under mechanical ventilation.
observational model: Other
time perspective: Other
measure: Incidence of inhomogeneous ventilation
time frame: within 24 hours after neurosurgical operative
description: In supine position, global image of EIT was divided into upper and lower part, each part accounting for 50%, which was named as non-dependent region and dependent region respectively. Inhomogeneous ventilation was defined as the ratio between tidal impedance variation of dependent region(VTdep) and global tidal impedance variation (VT) is less than 45% during stable Spontaneous breath, which was defined as variation of tidal volume less than 10% in continuous 6 breathes.
measure: The incidence of postoperative pulmonary complications(PPCs)
time frame: 28 days after neurosurgical operative
description: Postoperative pulmonary complication was defined as follows: Pneumonia was defined as recent pulmonary infiltration on chest radiography associated with at least 2 of the following signs: purulent tracheobronchial secretion, a body temperature > 38.3℃，and leukocytes in peripheral blood > 25% above the basal count. Tracheobronchitis was an increase in the volume or a change in the color or purulent aspect of tracheobronchial secretion with a normal chest radiograph. Atelectasis was evidence on chest radiography of pulmonary atelectasis associated with acute respiratory symptoms. Bronchoconstriction was classified as the presence of wheezing associated with acute respiratory symptoms with a good response to inhalatory bronchodilator medication.
measure: Length of ICU stay
time frame: through study completion, an average of 7 days
description: The number of days that patients stay in ICU.
measure: Length of hospital stay
time frame: through study completion, an average of 28 days
description: The number of days that patients stay in hospital.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: Gender was based on basic information collected at the moment when patients was admitted to hospital.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jian-Xin Zhou, MD
role: Principal Investigator
affiliation: Beijing Tiantan Hospital
last name: Jian-Xin Zhou, MD
phone: 8610 67096579
email: zhoujx.cn@icloud.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Capital Medical University
investigator full name: Jian-Xin Zhou
investigator title: Professor