<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/NCT02976844</url>
  </required_header>
  <id_info>
    <org_study_id>KY-2016-11-22</org_study_id>
    <nct_id>NCT02976844</nct_id>
  </id_info>
  <brief_title>Effect of Positive End-expiratory Pressure on Optimal Balloon Volume During Esophageal Pressure Monitoring</brief_title>
  <official_title>Effect of Positive End-expiratory Pressure on Optimal Balloon Volume During Esophageal Pressure Monitoring in Mechanical Ventilated Patients: A Clinical Feasibility 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Esophageal pressure (PES), which has been used as a surrogate for pleural pressure. The&#xD;
      volume of esophageal balloon can influence the accuracy of monitoring esophageal pressure.&#xD;
      The optimal balloon volume is directly dependent on surrounding pressure. In the present&#xD;
      study,the investigators will observe the optimal volume of esophageal balloon during the&#xD;
      different PEEP in bench and clinical study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The esophageal pressure (Pes) is used as a surrogate for pleural pressure to obtain&#xD;
      transpulmonary pressure. Catheter with air balloon is the most commonly used method to&#xD;
      measure the Pes. The optimal injected volume of the balloon is the key factor in accurate&#xD;
      measurement of Pes. The recoil pressure of the balloon turns up while the balloon is&#xD;
      over-filled, resulting in over-estimation of the PES; on the other hand, an under-filled&#xD;
      balloon also cannot properly transmit the surrounding pressure of balloon. However, the&#xD;
      researchers showed the optimal balloon volumes is related to the surrounding pressure and&#xD;
      even is not correspond with manufacturer's recommendations. Theoretically, when balloon&#xD;
      transmural pressure(PTM) is zero, representing the balloon in a condition with equivalent&#xD;
      pressure inside and outside of the balloon, it was defined as optimal volume. However, in&#xD;
      clinical settings, it is difficult to determine the balloon PTM, and therefore the optimal&#xD;
      volume cannot be obtained, because the surrounding pressure of the balloon cannot be&#xD;
      conveniently measured.&#xD;
&#xD;
      In the present study, the investigators will develop a simple method to obtain the optimal&#xD;
      balloon volume and observe the effect of positive end-expiratory pressure on optimal balloon&#xD;
      volume during esophageal pressure monitoring. The investigators want to validate the accuracy&#xD;
      of method in the bench study and clinical feasibility in mechanical ventilated patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 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 optimal balloon volume at different PEEP</measure>
    <time_frame>within 3 minutes after esophageal balloon volume changing</time_frame>
    <description>The 3 minutes after esophageal balloon volume changing, the investigators will record the end-expiratory and end-inspiratory esophageal pressure. The pressure and volume curve will be drawn to determine the optimal volume.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The transpulmonary pressure</measure>
    <time_frame>within 3 minutes after esophageal balloon volume changing</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">12</enrollment>
  <condition>Mechanical Ventilation</condition>
  <arm_group>
    <arm_group_label>Low PEEP group</arm_group_label>
    <description>The positive end-expiratory pressure was less than 10cmH2O</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High PEEP group</arm_group_label>
    <description>The positive end-expiratory pressure was higher or equal to 10cmH2O.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Positive end-expiratory Pressure</intervention_name>
    <description>Positive end-expiratory pressure will be used during mechanical ventilation.</description>
    <arm_group_label>High PEEP group</arm_group_label>
    <arm_group_label>Low PEEP group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        postoperative patients receiving mechanical ventilation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  postoperative patients with delayed emergence from general anesthesia admitted to the&#xD;
             ICU for mechanical ventilation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age under 18 years;&#xD;
&#xD;
          -  diagnosed or suspected esophageal varices;&#xD;
&#xD;
          -  history of chronic obstructive pulmonary diseases or asthma;&#xD;
&#xD;
          -  history of esophageal, gastric or lung surgery;&#xD;
&#xD;
          -  evidence of active air leak from the lung, including bronchopleural fistula,&#xD;
             pneumothorax, pneumomediastinum, or an existing chest tube;&#xD;
&#xD;
          -  evidence of severe coagulopathy.&#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>ICU, Beijing Tiantan Hospital, Capital Medical University</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>January 2017</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>August 3, 2017</last_update_submitted>
  <last_update_submitted_qc>August 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 7, 2017</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>
  <keyword>optimal balloon volume</keyword>
  <keyword>positive end-expiratory pressure</keyword>
  <!-- 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/NCT02976844
org study id: KY-2016-11-22
nct id: NCT02976844
lead sponsor: 
has dmc: Yes
Esophageal pressure (PES), which has been used as a surrogate for pleural pressure. The
      volume of esophageal balloon can influence the accuracy of monitoring esophageal pressure.
      The optimal balloon volume is directly dependent on surrounding pressure. In the present
      study,the investigators will observe the optimal volume of esophageal balloon during the
      different PEEP in bench and clinical study.
The esophageal pressure (Pes) is used as a surrogate for pleural pressure to obtain
      transpulmonary pressure. Catheter with air balloon is the most commonly used method to
      measure the Pes. The optimal injected volume of the balloon is the key factor in accurate
      measurement of Pes. The recoil pressure of the balloon turns up while the balloon is
      over-filled, resulting in over-estimation of the PES; on the other hand, an under-filled
      balloon also cannot properly transmit the surrounding pressure of balloon. However, the
      researchers showed the optimal balloon volumes is related to the surrounding pressure and
      even is not correspond with manufacturer's recommendations. Theoretically, when balloon
      transmural pressure(PTM) is zero, representing the balloon in a condition with equivalent
      pressure inside and outside of the balloon, it was defined as optimal volume. However, in
      clinical settings, it is difficult to determine the balloon PTM, and therefore the optimal
      volume cannot be obtained, because the surrounding pressure of the balloon cannot be
      conveniently measured.

      In the present study, the investigators will develop a simple method to obtain the optimal
      balloon volume and observe the effect of positive end-expiratory pressure on optimal balloon
      volume during esophageal pressure monitoring. The investigators want to validate the accuracy
      of method in the bench study and clinical feasibility in mechanical ventilated patients.
observational model: Case-Crossover
time perspective: Prospective
measure: The optimal balloon volume at different PEEP
time frame: within 3 minutes after esophageal balloon volume changing
description: The 3 minutes after esophageal balloon volume changing, the investigators will record the end-expiratory and end-inspiratory esophageal pressure. The pressure and volume curve will be drawn to determine the optimal volume.
measure: The transpulmonary pressure
time frame: within 3 minutes after esophageal balloon volume changing
arm group label: Low PEEP group
description: The positive end-expiratory pressure was less than 10cmH2O
arm group label: High PEEP group
description: The positive end-expiratory pressure was higher or equal to 10cmH2O.
intervention type: Procedure
intervention name: Positive end-expiratory Pressure
description: Positive end-expiratory pressure will be used during mechanical ventilation.
arm group label: High PEEP group
arm group label: Low PEEP group
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