<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/NCT03794414</url>
  </required_header>
  <id_info>
    <org_study_id>2018-11-028</org_study_id>
    <nct_id>NCT03794414</nct_id>
  </id_info>
  <brief_title>Positive End-expiratory Pressure (PEEP) in Predicting Fluid Responsiveness in Patients Undergoing One-lung Ventilation</brief_title>
  <official_title>The Influence of Positive End-expiratory Pressure (PEEP) in Predicting Fluid Responsiveness in Patients Undergoing One-lung Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hallym University Kangnam Sacred Heart Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hallym University Kangnam Sacred Heart 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>
      The present study is to evaluate the effect of positive end-expiratory pressure (PEEP) in&#xD;
      predicting fluid responsiveness in patients undergoing one-lung ventilation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Appropriate fluid challenge is crucial during lung surgery under one-lung ventilation.&#xD;
      Applying PEEP in mechanically ventilating patients changes dynamic hemodynamic parameters&#xD;
      (stroke volume variation, pulse pressure variation), which is more pronounced in hypovolemic&#xD;
      patients. The aim of the present study is to evaluate the mechanically ventilating patients&#xD;
      under one-lung ventilation requiring fluid resuscitation by applying PEEP to predict fluid&#xD;
      responsiveness.&#xD;
&#xD;
      The investigators hypothesized that applying PEEP in one-lung ventilating patients can also&#xD;
      change dynamic parameters and the magnitude of the change of stroke volume variation, pulse&#xD;
      pressure variation can predict fluid responsiveness. The investigator applied PEEP 10 mmHg in&#xD;
      one-lung ventilating patients and observed the dynamic parameters including stroke volume&#xD;
      variation, pulse pressure variation and then infused 6ml/kg of crystalloid for fluid&#xD;
      challenge and diagnosed fluid responsiveness as 10% increase of stroke volume after fluid&#xD;
      challenge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2019</start_date>
  <completion_date type="Actual">June 26, 2020</completion_date>
  <primary_completion_date type="Actual">June 26, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pulse pressure variation</measure>
    <time_frame>5 minutes after PEEP challenge</time_frame>
    <description>Temporary increase of PEEP will be able to predict fluid responsiveness using increase of pulse pressure variation over 1%.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>stroke volume variation</measure>
    <time_frame>5 minutes after PEEP challenge</time_frame>
    <description>Temporary increase of PEEP will be able to predict fluid responsiveness using increase of stroke volume variation over 1%.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Lung Cancer</condition>
  <condition>Lung Diseases</condition>
  <arm_group>
    <arm_group_label>fluid responder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with 10% or more increase in stroke volume after fluid challenge. Both arms receive PEEP challenge.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>fluid non-responder</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients with no increase or less than 10% increase in stroke volume after fluid challenge. Both arms receive PEEP challenge</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>PEEP challenge</intervention_name>
    <description>apply PEEP 10 mmHg in one-lung ventilating patients.</description>
    <arm_group_label>fluid non-responder</arm_group_label>
    <arm_group_label>fluid responder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing lung surgery under one-lung ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  arrhythmia&#xD;
&#xD;
          -  moderate to severe valvular heart disease moderate to severe pericardial effusion left&#xD;
             ventricular ejection fraction &lt; 40%&#xD;
&#xD;
          -  moderate to severe chronic obstructive lung disease&#xD;
&#xD;
          -  unable to insert oesophageal Doppler Monitor (ODM) probe ( esophageal stent,&#xD;
             esophageal cancer, previous esophageal surgery, esophageal stricture, esophageal&#xD;
             varices, pharyngeal pouch and severe coagulopathy )&#xD;
&#xD;
          -  patient refusal&#xD;
&#xD;
          -  cannot understand the protocol&#xD;
&#xD;
          -  less than 50kg or over 100kg in weight&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eun-mi Choi, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Kangnam Sungshim Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Kangnam Sungshim Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <last_update_submitted>July 26, 2020</last_update_submitted>
  <last_update_submitted_qc>July 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hallym University Kangnam Sacred Heart Hospital</investigator_affiliation>
    <investigator_full_name>Choi Eun MI</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>Lung Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>However, I can always share if required.</ipd_description>
  </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/NCT03794414
org study id: 2018-11-028
nct id: NCT03794414
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The present study is to evaluate the effect of positive end-expiratory pressure (PEEP) in
      predicting fluid responsiveness in patients undergoing one-lung ventilation.
Appropriate fluid challenge is crucial during lung surgery under one-lung ventilation.
      Applying PEEP in mechanically ventilating patients changes dynamic hemodynamic parameters
      (stroke volume variation, pulse pressure variation), which is more pronounced in hypovolemic
      patients. The aim of the present study is to evaluate the mechanically ventilating patients
      under one-lung ventilation requiring fluid resuscitation by applying PEEP to predict fluid
      responsiveness.

      The investigators hypothesized that applying PEEP in one-lung ventilating patients can also
      change dynamic parameters and the magnitude of the change of stroke volume variation, pulse
      pressure variation can predict fluid responsiveness. The investigator applied PEEP 10 mmHg in
      one-lung ventilating patients and observed the dynamic parameters including stroke volume
      variation, pulse pressure variation and then infused 6ml/kg of crystalloid for fluid
      challenge and diagnosed fluid responsiveness as 10% increase of stroke volume after fluid
      challenge.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: pulse pressure variation
time frame: 5 minutes after PEEP challenge
description: Temporary increase of PEEP will be able to predict fluid responsiveness using increase of pulse pressure variation over 1%.
measure: stroke volume variation
time frame: 5 minutes after PEEP challenge
description: Temporary increase of PEEP will be able to predict fluid responsiveness using increase of stroke volume variation over 1%.
arm group label: fluid responder
arm group type: Experimental
description: patients with 10% or more increase in stroke volume after fluid challenge. Both arms receive PEEP challenge.
arm group label: fluid non-responder
arm group type: Experimental
description: patients with no increase or less than 10% increase in stroke volume after fluid challenge. Both arms receive PEEP challenge
intervention type: Procedure
intervention name: PEEP challenge
description: apply PEEP 10 mmHg in one-lung ventilating patients.
arm group label: fluid non-responder
arm group label: fluid responder
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Eun-mi Choi, Professor
role: Study Chair
affiliation: Kangnam Sungshim Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Hallym University Kangnam Sacred Heart Hospital
investigator full name: Choi Eun MI
investigator title: Professor
mesh term: Lung Diseases
sharing ipd: No
ipd description: However, I can always share if required.