<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/NCT03030963</url>
  </required_header>
  <id_info>
    <org_study_id>3-2016-0241</org_study_id>
    <nct_id>NCT03030963</nct_id>
  </id_info>
  <brief_title>Effect of Equal Ratio Ventilation on Blood Loss During Posterior Lumbar Interbody Fusion Surgery</brief_title>
  <official_title>Effect of Equal Ratio Ventilation on Blood Loss During Posterior Lumbar Interbody Fusion Surgery: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gangnam Severance Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gangnam Severance Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ventilator mode change was associated with decrease in blood loss during posterior lumbar&#xD;
      interbody fusion (PLIF) due to decrease in the peak inspiratory pressure (PIP). The purpose&#xD;
      of this study was to determine the effect of equal ratio ventilation (ERV), which sets the&#xD;
      I:E ratio of the ventilator to 1:1 during volume controlled ventilaiton, on surgical blood&#xD;
      loss during PLIF. Investigators hypothesized that ERV would decrease surgical blood loss due&#xD;
      to decrease in the PIP.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After anesthesia, patients will receive ventilator settings according to theri group. The CVP&#xD;
      will be measured before and after the prone position to ensure the proper positioning. Airway&#xD;
      pressures including peak inspiratory pressure, mean/plateau airway pressure, arterial blood&#xD;
      gas analysis data, hct, lactate, body temperature, mean arterial pressure, cardiac index.&#xD;
      Recodings will be done 5min afte the induction, 5 min after the prone positioning, sikin&#xD;
      suture, and 5min after supine position. Amount of bleeding, coagulation profile and Hct will&#xD;
      be recorded 72 hrs after the surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2017</start_date>
  <completion_date type="Actual">March 31, 2018</completion_date>
  <primary_completion_date type="Actual">March 4, 2018</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>The amount of intraoperative surgical bleeding</measure>
    <time_frame>At the end of the surgery, approximately 4 hrs.</time_frame>
    <description>The surgical blood loss was compared in the two groups (ERV vs. conrol) during posterior lumbar interbody fusion(PLIF) in prone position.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Blood Loss, Surgical</condition>
  <arm_group>
    <arm_group_label>Equal-ratio ventilation(ERV) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ventilator inspiration to expiration ratio will be set 1:1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>ventilator inspiration to expiration ratio will be set 1:2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Equal ratio ventilation(ERV)</intervention_name>
    <description>Set the inspiratory to expiratory ratio 1:1 during mechanical ventilation</description>
    <arm_group_label>Equal-ratio ventilation(ERV) group</arm_group_label>
    <other_name>I:E ratio 1:1</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>I:E Ratio &quot;1:2</intervention_name>
    <description>Set the inspiratory to expiratory ratio 1:2 during mechanical ventilation</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1) Age : 20~75 yr-old 2) Surgery : Posterior lumbar interbody fusion(PLIF) 2~3 levels&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1) Urgent or Emergency case 2) Previous lnstrumentation of lumbar spine (Exclusion :&#xD;
             Discectomy, Partial hemilaminiectomy, etc) 3) Concurrent other operation 4) Patients&#xD;
             who cannot understand informed consent (ex. Illiterate, Foreigner) 5) Obesity&#xD;
             (BIM&gt;30kg/m2) 6) Recent myocardial infarction (within 3 months) 7) Reduced left and&#xD;
             right ventricular function (Ejection fraction&lt;40%) or Congestive heart failure 8)&#xD;
             Preoperative dysrhythmia 9) Aspirin or Plavix during perioperative periods 10) Lung&#xD;
             disease 11) Chronic kidney disease or Dialysis 12) Severe hepatic disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiyoung Kim</last_name>
    <role>Principal Investigator</role>
    <affiliation>Gangnam Severance Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gangnam Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06273</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>January 22, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>August 3, 2018</last_update_submitted>
  <last_update_submitted_qc>August 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gangnam Severance Hospital</investigator_affiliation>
    <investigator_full_name>Ji-young Kim</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Equal ratio ventilation(ERV)</keyword>
  <keyword>Peak inspiratory pressure(PIP)</keyword>
  <keyword>Blood loss</keyword>
  <keyword>Posterior lumbar interbody fusion(PLIF)</keyword>
  <keyword>Prone position</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</mesh_term>
    <mesh_term>Blood Loss, Surgical</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/NCT03030963
org study id: 3-2016-0241
nct id: NCT03030963
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Ventilator mode change was associated with decrease in blood loss during posterior lumbar
      interbody fusion (PLIF) due to decrease in the peak inspiratory pressure (PIP). The purpose
      of this study was to determine the effect of equal ratio ventilation (ERV), which sets the
      I:E ratio of the ventilator to 1:1 during volume controlled ventilaiton, on surgical blood
      loss during PLIF. Investigators hypothesized that ERV would decrease surgical blood loss due
      to decrease in the PIP.
After anesthesia, patients will receive ventilator settings according to theri group. The CVP
      will be measured before and after the prone position to ensure the proper positioning. Airway
      pressures including peak inspiratory pressure, mean/plateau airway pressure, arterial blood
      gas analysis data, hct, lactate, body temperature, mean arterial pressure, cardiac index.
      Recodings will be done 5min afte the induction, 5 min after the prone positioning, sikin
      suture, and 5min after supine position. Amount of bleeding, coagulation profile and Hct will
      be recorded 72 hrs after the surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: The amount of intraoperative surgical bleeding
time frame: At the end of the surgery, approximately 4 hrs.
description: The surgical blood loss was compared in the two groups (ERV vs. conrol) during posterior lumbar interbody fusion(PLIF) in prone position.
arm group label: Equal-ratio ventilation(ERV) group
arm group type: Experimental
description: ventilator inspiration to expiration ratio will be set 1:1.
arm group label: Control group
arm group type: Active Comparator
description: ventilator inspiration to expiration ratio will be set 1:2.
intervention type: Other
intervention name: Equal ratio ventilation(ERV)
description: Set the inspiratory to expiratory ratio 1:1 during mechanical ventilation
arm group label: Equal-ratio ventilation(ERV) group
other name: I:E ratio 1:1
intervention type: Other
intervention name: I:E Ratio "1:2
description: Set the inspiratory to expiratory ratio 1:2 during mechanical ventilation
arm group label: Control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jiyoung Kim
role: Principal Investigator
affiliation: Gangnam Severance Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Gangnam Severance Hospital
investigator full name: Ji-young Kim
investigator title: Associate Professor
mesh term: Hemorrhage
mesh term: Blood Loss, Surgical
sharing ipd: No