<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/NCT02977143</url>
  </required_header>
  <id_info>
    <org_study_id>1609-101-793</org_study_id>
    <nct_id>NCT02977143</nct_id>
  </id_info>
  <brief_title>Positive End-expiratory Pressure-induced Increase in Central Venous Pressure as a Predictor of Fluid Responsiveness in Robot-assisted Laparoscopic Surgery</brief_title>
  <official_title>Comparison of Positive End-expiratory Pressure-induced Increase in Central Venous Pressure and Stroke Volume Variation to Predict Fluid Responsiveness in Robot-assisted Laparoscopic Surgery: A Prospective Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac preload&#xD;
      and cardiac output is important for clinical prognosis. Previous studies reported the&#xD;
      positive end-expiratory pressure (PEEP)-induced increase in central venous pressure (CVP)&#xD;
      could be a accurate predictor of fluid responsiveness in cardiac surgical patients. The&#xD;
      authors attempt to evaluate the predictability of PEEP-induced increase in CVP as well as&#xD;
      stroke volume variation in urologic robotic surgery with Steep Trendelenburg position.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac preload&#xD;
      and cardiac output is important for clinical prognosis. As a preload index, the&#xD;
      predictability of central venous pressure, pulse pressure variation and stroke volume&#xD;
      variations may be impaired due to the impaired hemodynamics that result from the effect of&#xD;
      increased abdominal pressure and decreased venous return. Previous studies reported the&#xD;
      positive end-expiratory pressure (PEEP)-induced increase in central venous pressure (CVP)&#xD;
      could be a accurate predictor of fluid responsiveness in cardiac surgical patients.&#xD;
      Therefore, the authors attempt to evaluate the predictability of PEEP-induced increase in CVP&#xD;
      as well as stroke volume variation in urologic robotic surgery with Steep Trendelenburg&#xD;
      position.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>fluid responsiveness</measure>
    <time_frame>5 minutes after administration of 300 ml volulyte</time_frame>
    <description>fluid responsiveness is determined when increase in cardiac index is more than 10%</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>central venous pressure</measure>
    <time_frame>one hour after the initiation of pneumoperitoneum</time_frame>
    <description>T1: baseline measurement of central venous pressure with positive end-expiratory pressure of zero</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiac index</measure>
    <time_frame>one hour after the initiation of pneumoperitoneum</time_frame>
    <description>T1: baseline measurement of cardiac index with positive end-expiratory pressure of zero</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stroke volume variation</measure>
    <time_frame>one hour after the initiation of pneumoperitoneum</time_frame>
    <description>T1: baseline measurement of stroke volume variation with positive end-expiratory pressure of zero</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>abdominal pressure</measure>
    <time_frame>one hour after the initiation of pneumoperitoneum</time_frame>
    <description>T1: baseline measurement of abdominal pressure with positive end-expiratory pressure of zero</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>central venous pressure</measure>
    <time_frame>5 minutes after the application of positive end-expiratory pressure of 10 cmH2O</time_frame>
    <description>T2: measurement of positive end-expiratory pressure-induce increase in central venous pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiac index</measure>
    <time_frame>5 minutes after the application of positive end-expiratory pressure of 10 cmH2O</time_frame>
    <description>T2: measurement of cardiac index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stroke volume variation</measure>
    <time_frame>5 minutes after the application of positive end-expiratory pressure of 10 cmH2O</time_frame>
    <description>T2: measurement of stroke volume variation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>abdominal pressure</measure>
    <time_frame>5 minutes after the application of positive end-expiratory pressure of 10 cmH2O</time_frame>
    <description>T2: measurement of abdominal pressure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>central venous pressure</measure>
    <time_frame>5 minutes after removal of positive end-expiratory pressure</time_frame>
    <description>T3: second baseline measurement of central venous pressure with positive end-expiratory pressure of zero</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiac index</measure>
    <time_frame>5 minutes after removal of positive end-expiratory pressure</time_frame>
    <description>T3: second baseline measurement of cardiac index with positive end-expiratory pressure of zero</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stroke volume variation</measure>
    <time_frame>5 minutes after removal of positive end-expiratory pressure</time_frame>
    <description>T3: second baseline measurement of stroke volume variation with positive end-expiratory pressure of zero</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>abdominal pressure</measure>
    <time_frame>5 minutes after removal of positive end-expiratory pressure</time_frame>
    <description>T3: second baseline measurement of abdominal pressure with positive end-expiratory pressure of zero</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>central venous pressure</measure>
    <time_frame>T4: 5 minutes after administration of volulyte 300 ml</time_frame>
    <description>measurement of central venous pressure after fluid administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cardiac index</measure>
    <time_frame>T4: 5 minutes after administration of volulyte 300 ml</time_frame>
    <description>measurement of cardiac index after fluid administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>stroke volume variation</measure>
    <time_frame>T4: 5 minutes after administration of volulyte 300 ml</time_frame>
    <description>measurement of stroke volume variation after fluid administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>abdominal pressure</measure>
    <time_frame>T4: 5 minutes after administration of volulyte 300 ml</time_frame>
    <description>measurement of abdominal pressure after fluid administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>arterial oxygen partial pressure (mmHg)</measure>
    <time_frame>5 minutes after anesthesia induction</time_frame>
    <description>arterial blood gas analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>arterial carbon dioxide partial pressure (mmHg)</measure>
    <time_frame>5 minutes after anesthesia induction</time_frame>
    <description>arterial blood gas analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>arterial oxygen partial pressure (mmHg)</measure>
    <time_frame>1 minutes after the application of positive end-expiratory pressure of 10 cmH2O</time_frame>
    <description>arterial blood gas analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>arterial carbon dioxide partial pressure (mmHg)</measure>
    <time_frame>1 minutes after the application of positive end-expiratory pressure of 10 cmH2O</time_frame>
    <description>arterial blood gas analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>arterial oxygen partial pressure (mmHg)</measure>
    <time_frame>1 minutes after the start of skin closure</time_frame>
    <description>arterial blood gas analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>arterial carbon dioxide partial pressure (mmHg)</measure>
    <time_frame>1 minutes after the start of skin closure</time_frame>
    <description>arterial blood gas analysis</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Prostatic Neoplasm</condition>
  <condition>Urinary Bladder Neoplasm</condition>
  <arm_group>
    <arm_group_label>Fluid responsiveness test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First, apply 10 cmH2O positive endexpiratory pressure (PEEP) and measure the increase in central venous pressure (CVP) as well as other preload indexes (central venous pressure, mean arterial pressure, stroke volume variation).&#xD;
Second, measure the increase in cardiac index after administration of volulyte 300 ml.&#xD;
If cardiac index increase more than 10%, fluid responsiveness is confirmed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fluid loading of volulyte 300 ml</intervention_name>
    <description>Administration of volulyte 300 ml and measurement of increase in cardiac index</description>
    <arm_group_label>Fluid responsiveness test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient undergoing robot-assisted laparoscopic radical prostatectomy or&#xD;
             cystectomy.&#xD;
&#xD;
          -  American Society of Anesthesiologist Physical Status Classification of 1, 2 or 3.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medical history of arrhythmia or new-onset arrhythmia after anesthesia induction.&#xD;
&#xD;
          -  Valvular or ischemic heart disease or left ventricular ejection fraction less than&#xD;
             40%.&#xD;
&#xD;
          -  Any significant pulmonary disease or history of chronic obstructive pulmonary disease&#xD;
&#xD;
          -  End-stage renal disease or preoperative creatinine &gt; 1.4 mg/dl&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>November 27, 2016</study_first_submitted>
  <study_first_submitted_qc>November 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>April 1, 2018</last_update_submitted>
  <last_update_submitted_qc>April 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Won Ho Kim, MD</investigator_full_name>
    <investigator_title>Clinical Associate Professor</investigator_title>
  </responsible_party>
  <keyword>fluid responsiveness</keyword>
  <keyword>central venous pressure</keyword>
  <keyword>positive end-expiratory pressure</keyword>
  <keyword>robot surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Urinary Bladder Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT02977143
org study id: 1609-101-793
nct id: NCT02977143
lead sponsor: 
has dmc: Yes
In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac preload
      and cardiac output is important for clinical prognosis. Previous studies reported the
      positive end-expiratory pressure (PEEP)-induced increase in central venous pressure (CVP)
      could be a accurate predictor of fluid responsiveness in cardiac surgical patients. The
      authors attempt to evaluate the predictability of PEEP-induced increase in CVP as well as
      stroke volume variation in urologic robotic surgery with Steep Trendelenburg position.
In urologic robotic surgery with steep Trendelenburg position, maintenance of cardiac preload
      and cardiac output is important for clinical prognosis. As a preload index, the
      predictability of central venous pressure, pulse pressure variation and stroke volume
      variations may be impaired due to the impaired hemodynamics that result from the effect of
      increased abdominal pressure and decreased venous return. Previous studies reported the
      positive end-expiratory pressure (PEEP)-induced increase in central venous pressure (CVP)
      could be a accurate predictor of fluid responsiveness in cardiac surgical patients.
      Therefore, the authors attempt to evaluate the predictability of PEEP-induced increase in CVP
      as well as stroke volume variation in urologic robotic surgery with Steep Trendelenburg
      position.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: fluid responsiveness
time frame: 5 minutes after administration of 300 ml volulyte
description: fluid responsiveness is determined when increase in cardiac index is more than 10%
measure: central venous pressure
time frame: one hour after the initiation of pneumoperitoneum
description: T1: baseline measurement of central venous pressure with positive end-expiratory pressure of zero
measure: cardiac index
time frame: one hour after the initiation of pneumoperitoneum
description: T1: baseline measurement of cardiac index with positive end-expiratory pressure of zero
measure: stroke volume variation
time frame: one hour after the initiation of pneumoperitoneum
description: T1: baseline measurement of stroke volume variation with positive end-expiratory pressure of zero
measure: abdominal pressure
time frame: one hour after the initiation of pneumoperitoneum
description: T1: baseline measurement of abdominal pressure with positive end-expiratory pressure of zero
measure: central venous pressure
time frame: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
description: T2: measurement of positive end-expiratory pressure-induce increase in central venous pressure
measure: cardiac index
time frame: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
description: T2: measurement of cardiac index
measure: stroke volume variation
time frame: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
description: T2: measurement of stroke volume variation
measure: abdominal pressure
time frame: 5 minutes after the application of positive end-expiratory pressure of 10 cmH2O
description: T2: measurement of abdominal pressure
measure: central venous pressure
time frame: 5 minutes after removal of positive end-expiratory pressure
description: T3: second baseline measurement of central venous pressure with positive end-expiratory pressure of zero
measure: cardiac index
time frame: 5 minutes after removal of positive end-expiratory pressure
description: T3: second baseline measurement of cardiac index with positive end-expiratory pressure of zero
measure: stroke volume variation
time frame: 5 minutes after removal of positive end-expiratory pressure
description: T3: second baseline measurement of stroke volume variation with positive end-expiratory pressure of zero
measure: abdominal pressure
time frame: 5 minutes after removal of positive end-expiratory pressure
description: T3: second baseline measurement of abdominal pressure with positive end-expiratory pressure of zero
measure: central venous pressure
time frame: T4: 5 minutes after administration of volulyte 300 ml
description: measurement of central venous pressure after fluid administration
measure: cardiac index
time frame: T4: 5 minutes after administration of volulyte 300 ml
description: measurement of cardiac index after fluid administration
measure: stroke volume variation
time frame: T4: 5 minutes after administration of volulyte 300 ml
description: measurement of stroke volume variation after fluid administration
measure: abdominal pressure
time frame: T4: 5 minutes after administration of volulyte 300 ml
description: measurement of abdominal pressure after fluid administration
measure: arterial oxygen partial pressure (mmHg)
time frame: 5 minutes after anesthesia induction
description: arterial blood gas analysis
measure: arterial carbon dioxide partial pressure (mmHg)
time frame: 5 minutes after anesthesia induction
description: arterial blood gas analysis
measure: arterial oxygen partial pressure (mmHg)
time frame: 1 minutes after the application of positive end-expiratory pressure of 10 cmH2O
description: arterial blood gas analysis
measure: arterial carbon dioxide partial pressure (mmHg)
time frame: 1 minutes after the application of positive end-expiratory pressure of 10 cmH2O
description: arterial blood gas analysis
measure: arterial oxygen partial pressure (mmHg)
time frame: 1 minutes after the start of skin closure
description: arterial blood gas analysis
measure: arterial carbon dioxide partial pressure (mmHg)
time frame: 1 minutes after the start of skin closure
description: arterial blood gas analysis
arm group label: Fluid responsiveness test
arm group type: Experimental
description: First, apply 10 cmH2O positive endexpiratory pressure (PEEP) and measure the increase in central venous pressure (CVP) as well as other preload indexes (central venous pressure, mean arterial pressure, stroke volume variation).
Second, measure the increase in cardiac index after administration of volulyte 300 ml.
If cardiac index increase more than 10%, fluid responsiveness is confirmed.
intervention type: Procedure
intervention name: Fluid loading of volulyte 300 ml
description: Administration of volulyte 300 ml and measurement of increase in cardiac index
arm group label: Fluid responsiveness test
criteria: 
gender: Male
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Won Ho Kim, MD
investigator title: Clinical Associate Professor
mesh term: Neoplasms
mesh term: Prostatic Neoplasms
mesh term: Urinary Bladder Neoplasms
sharing ipd: No