<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/NCT04451421</url>
  </required_header>
  <id_info>
    <org_study_id>transpulmonary pressure</org_study_id>
    <nct_id>NCT04451421</nct_id>
  </id_info>
  <brief_title>Effects of Standing at Different Angles on Transpulmonary Pressure</brief_title>
  <official_title>Effects of Standing at Different Angles on Transpulmonary Pressure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese PLA General Hospital</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>
      Effects of standing at different angles on transpulmonary pressure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: To study the effect of different standing angles on cross-lung&#xD;
      pressure.Background: Long-term bed rest in ICU patients leads to upward movement of diaphragm&#xD;
      and increased intrathoracic pressure in mechanically ventilated patients, resulting in lower&#xD;
      cross-lung pressure. If the end-expiratory cross-lung pressure is negative, lung tissue&#xD;
      compression and atelectasis will occur.Standing can lower the diaphragm, improve the pressure&#xD;
      across the lungs, and improve ventilation.Selection methods: patients with invasive&#xD;
      mechanical ventilation in the ICU, on the premise of stable hemodynamics, with the aid of&#xD;
      electric bed training in standing in different angles, start from 20 degrees, 5 degrees up&#xD;
      every five minutes, the largest up to 80 degrees, each Angle across the pulmonary pressure,&#xD;
      die cavity ratio, tidal volume and breathe out carbon dioxide at the end of the record, and&#xD;
      record whether low blood pressure, an accident in the process of take off the tube and other&#xD;
      adverse reactions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2020</start_date>
  <completion_date type="Anticipated">October 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>transpulmonary pressure</measure>
    <time_frame>5 minutes</time_frame>
    <description>End-expiratory pressure across the lungs is recommended at 0-5cmH2O.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Esophageal pressure</measure>
    <time_frame>5 minutes</time_frame>
    <description>The change in esophageal pressure represents the degree of inspiratory effort.The greater the variation, the harder the inhale.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Dead space rate</measure>
    <time_frame>5 minutes</time_frame>
    <description>the smaller，the better</description>
  </primary_outcome>
  <primary_outcome>
    <measure>tidal volume</measure>
    <time_frame>5 minutes</time_frame>
    <description>Standard tidal volume: standard weight based on height, 6 to 8ml per kg body weight</description>
  </primary_outcome>
  <primary_outcome>
    <measure>partial pressure of carbon dioxide in endexpiratory gas</measure>
    <time_frame>5 minutes</time_frame>
    <description>The smaller the difference between pCO2 and arterial blood gas, the better</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>adverse reaction</measure>
    <time_frame>an hour</time_frame>
    <description>hypotension、Accident to take off the tube、Drop of bed，Record the number of times it happens.The more it happens, the less safe it is.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Standing Angle</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Assist the electric hospital bed to conduct different Angle standing training, starting from 20 degrees, every five minutes to rise 5 degrees, the maximum rise to 80 degrees</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Change of standing Angle</intervention_name>
    <description>Change the patient's standing Angle by using an electric bed</description>
    <arm_group_label>Standing Angle</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The age is ≥ 18 years old;&#xD;
&#xD;
          -  the hemodynamics is stable;&#xD;
&#xD;
          -  50 &lt; heart rate &lt; 120 beats / min ;&#xD;
&#xD;
          -  90 &lt; systolic blood pressure &lt; 200mmHg ;&#xD;
&#xD;
          -  55 &lt; mean arterial pressure &lt; 120mmHg;&#xD;
&#xD;
          -  do not increase the dose of pressor drugs for at least 2 hours;&#xD;
&#xD;
          -  intracranial pressure is stable and there are no seizures within 24 hours;&#xD;
&#xD;
          -  the respiratory state is stable;&#xD;
&#xD;
          -  the patient's finger pulse oxygen saturation ≥ 88%;&#xD;
&#xD;
          -  10 &lt; respiratory frequency &lt; 35 beats / min.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy;&#xD;
&#xD;
          -  acute cardio-cerebrovascular events;&#xD;
&#xD;
          -  spinal or limb fractures;&#xD;
&#xD;
          -  active bleeding.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>95 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>xin li xie, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Medical Center of PLA General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zhao Ying</last_name>
    <phone>17600953801</phone>
    <phone_ext>17600953801</phone_ext>
    <email>1412888703@qq.com</email>
  </overall_contact>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
    <investigator_full_name>wang kaifei</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</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/NCT04451421
org study id: transpulmonary pressure
nct id: NCT04451421
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Effects of standing at different angles on transpulmonary pressure
Objective: To study the effect of different standing angles on cross-lung
      pressure.Background: Long-term bed rest in ICU patients leads to upward movement of diaphragm
      and increased intrathoracic pressure in mechanically ventilated patients, resulting in lower
      cross-lung pressure. If the end-expiratory cross-lung pressure is negative, lung tissue
      compression and atelectasis will occur.Standing can lower the diaphragm, improve the pressure
      across the lungs, and improve ventilation.Selection methods: patients with invasive
      mechanical ventilation in the ICU, on the premise of stable hemodynamics, with the aid of
      electric bed training in standing in different angles, start from 20 degrees, 5 degrees up
      every five minutes, the largest up to 80 degrees, each Angle across the pulmonary pressure,
      die cavity ratio, tidal volume and breathe out carbon dioxide at the end of the record, and
      record whether low blood pressure, an accident in the process of take off the tube and other
      adverse reactions.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: transpulmonary pressure
time frame: 5 minutes
description: End-expiratory pressure across the lungs is recommended at 0-5cmH2O.
measure: Esophageal pressure
time frame: 5 minutes
description: The change in esophageal pressure represents the degree of inspiratory effort.The greater the variation, the harder the inhale.
measure: Dead space rate
time frame: 5 minutes
description: the smaller，the better
measure: tidal volume
time frame: 5 minutes
description: Standard tidal volume: standard weight based on height, 6 to 8ml per kg body weight
measure: partial pressure of carbon dioxide in endexpiratory gas
time frame: 5 minutes
description: The smaller the difference between pCO2 and arterial blood gas, the better
measure: adverse reaction
time frame: an hour
description: hypotension、Accident to take off the tube、Drop of bed，Record the number of times it happens.The more it happens, the less safe it is.
arm group label: Standing Angle
arm group type: Experimental
description: Assist the electric hospital bed to conduct different Angle standing training, starting from 20 degrees, every five minutes to rise 5 degrees, the maximum rise to 80 degrees
intervention type: Behavioral
intervention name: Change of standing Angle
description: Change the patient's standing Angle by using an electric bed
arm group label: Standing Angle
criteria: 
gender: All
minimum age: 18 Years
maximum age: 95 Years
healthy volunteers: No
last name: xin li xie, Ph.D.
role: Principal Investigator
affiliation: The First Medical Center of PLA General Hospital
last name: Zhao Ying
phone: 17600953801
phone ext: 17600953801
email: 1412888703@qq.com
responsible party type: Principal Investigator
investigator affiliation: Chinese PLA General Hospital
investigator full name: wang kaifei
investigator title: Director
mesh term: Lung Diseases