<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/NCT02208570</url>
  </required_header>
  <id_info>
    <org_study_id>JHBahk_PPV_predictability</org_study_id>
    <nct_id>NCT02208570</nct_id>
  </id_info>
  <brief_title>Predictability of the Pulse Pressure Variation (PPV) During Spontaneous Ventilation on the Incidence of Hypotension During Induction of Anesthesia</brief_title>
  <official_title>Predictability of the Pulse Pressure Variation During Spontaneous Ventilation on the Incidence of Hypotension During Induction of Anesthesia</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>
  <brief_summary>
    <textblock>
      The purpose of this study is to find out the predictability of the pulse pressure variation&#xD;
      during spontaneous ventilation on the incidence of hypotension during induction of&#xD;
      anesthesia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2014</start_date>
  <primary_completion_date type="Anticipated">December 2016</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes of heart rate and systolic arterial blood pressure from baseline values immediately before tracheal intubation</measure>
    <time_frame>Three minutes after anesthesia agent injection</time_frame>
    <description>First, we measure the baseline heart rate and systolic arterial blood pressure and calculate the baseline heart rate and blood pressure.&#xD;
At 3 minutes after anesthesia agent injection we record the heart rate and blood pressure, and perform endotracheal intubation. Then we calculate the percentile change of blood pressure and heart rate from the baseline values.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes of heart rate and systolic arterial blood pressure from baseline values, three minutes before intubation</measure>
    <time_frame>Three minutes before endotracheal intubation</time_frame>
    <description>We collect the patient's vital signs for 1 second interval during anesthesia induction. We collect the patient's heart rate and blood pressure values for three minutes before endotracheal intubation, and average the numbers. Then we compare the numbers from the baseline value and calculate the changes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes of heart rate and systolic arterial blood pressure from baseline values, three minutes after intubation</measure>
    <time_frame>Three minutes after endotracheal intubation</time_frame>
    <description>We collect the patient's vital signs for 1 second interval during anesthesia induction. We collect the patient's heart rate and blood pressure values for three minutes after endotracheal intubation, and average the numbers. Then we compare the numbers from the baseline value and calculate the changes.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">172</enrollment>
  <condition>Hypotension</condition>
  <arm_group>
    <arm_group_label>P(+)V(+)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PPV&gt;14% before anesthesia induction, HES 6ml/kg infused</description>
  </arm_group>
  <arm_group>
    <arm_group_label>P(+)V(-)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PPV&gt;14% before anesthesia induction, no additional volume infused</description>
  </arm_group>
  <arm_group>
    <arm_group_label>P(-)V(+)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PPV&lt;14% before anesthesia induction, HES 6ml/kg infused</description>
  </arm_group>
  <arm_group>
    <arm_group_label>P(-)V(-)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PPV&lt;14% before anesthesia induction, no additional volume infused</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PPV&gt;14%</intervention_name>
    <description>Patients whose preoperative pulse pressure variation during spontaneous ventilation exceed 14</description>
    <arm_group_label>P(+)V(+)</arm_group_label>
    <arm_group_label>P(+)V(-)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Volume loading</intervention_name>
    <description>Hydroxyethyl starch solution 6ml/kg iv injection</description>
    <arm_group_label>P(+)V(+)</arm_group_label>
    <arm_group_label>P(-)V(+)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PPV&lt;14%</intervention_name>
    <description>Patients whose preoperative pulse pressure variation during spontaneous ventilation does not exceed 14</description>
    <arm_group_label>P(-)V(+)</arm_group_label>
    <arm_group_label>P(-)V(-)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing general anesthesia induction with intravenous anesthesia using&#xD;
             propofol and remifentanil&#xD;
&#xD;
          -  Patients requiring invasive arterial blood pressure monitoring for the surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of consent&#xD;
&#xD;
          -  Patients with heart disease (symptomatic valvular heart disease, intracardiac shunt,&#xD;
             pulmonary hypertension with pulmonary systolic arterial pressure exceeding 40mmHg)&#xD;
&#xD;
          -  FEV1 ≤ 50% predicted FEV1&#xD;
&#xD;
          -  Patients with chronic renal failure&#xD;
&#xD;
          -  ASA class IV, V, VI&#xD;
&#xD;
          -  Systolic arterial blood pressure below 90mmHg before induction of anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jae-Hyon Bahk</last_name>
    <phone>82-2-2072-2818</phone>
    <email>bahkjh@snu.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jae-Hyon Bahk</last_name>
      <phone>82-2-2072-0641</phone>
      <email>bahkjh@snu.ac.kr</email>
    </contact>
    <investigator>
      <last_name>Jae-Hyon Bahk</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>July 14, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 5, 2014</study_first_posted>
  <last_update_submitted>April 19, 2016</last_update_submitted>
  <last_update_submitted_qc>April 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jae-Hyon Bahk, MD, PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Hypotension during anesthesia induction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</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/NCT02208570
org study id: JHBahk_PPV_predictability
nct id: NCT02208570
lead sponsor: 
The purpose of this study is to find out the predictability of the pulse pressure variation
      during spontaneous ventilation on the incidence of hypotension during induction of
      anesthesia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Changes of heart rate and systolic arterial blood pressure from baseline values immediately before tracheal intubation
time frame: Three minutes after anesthesia agent injection
description: First, we measure the baseline heart rate and systolic arterial blood pressure and calculate the baseline heart rate and blood pressure.
At 3 minutes after anesthesia agent injection we record the heart rate and blood pressure, and perform endotracheal intubation. Then we calculate the percentile change of blood pressure and heart rate from the baseline values.
measure: Changes of heart rate and systolic arterial blood pressure from baseline values, three minutes before intubation
time frame: Three minutes before endotracheal intubation
description: We collect the patient's vital signs for 1 second interval during anesthesia induction. We collect the patient's heart rate and blood pressure values for three minutes before endotracheal intubation, and average the numbers. Then we compare the numbers from the baseline value and calculate the changes.
measure: Changes of heart rate and systolic arterial blood pressure from baseline values, three minutes after intubation
time frame: Three minutes after endotracheal intubation
description: We collect the patient's vital signs for 1 second interval during anesthesia induction. We collect the patient's heart rate and blood pressure values for three minutes after endotracheal intubation, and average the numbers. Then we compare the numbers from the baseline value and calculate the changes.
arm group label: P(+)V(+)
arm group type: Experimental
description: PPV>14% before anesthesia induction, HES 6ml/kg infused
arm group label: P(+)V(-)
arm group type: Experimental
description: PPV>14% before anesthesia induction, no additional volume infused
arm group label: P(-)V(+)
arm group type: Experimental
description: PPV<14% before anesthesia induction, HES 6ml/kg infused
arm group label: P(-)V(-)
arm group type: Experimental
description: PPV<14% before anesthesia induction, no additional volume infused
intervention type: Other
intervention name: PPV>14%
description: Patients whose preoperative pulse pressure variation during spontaneous ventilation exceed 14
arm group label: P(+)V(+)
arm group label: P(+)V(-)
intervention type: Drug
intervention name: Volume loading
description: Hydroxyethyl starch solution 6ml/kg iv injection
arm group label: P(+)V(+)
arm group label: P(-)V(+)
intervention type: Other
intervention name: PPV<14%
description: Patients whose preoperative pulse pressure variation during spontaneous ventilation does not exceed 14
arm group label: P(-)V(+)
arm group label: P(-)V(-)
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jae-Hyon Bahk
phone: 82-2-2072-2818
email: bahkjh@snu.ac.kr
facility: 
status: Recruiting
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jae-Hyon Bahk, MD, PhD
investigator title: Professor
mesh term: Hypotension