<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/NCT02207296</url>
  </required_header>
  <id_info>
    <org_study_id>2014-A00330-47</org_study_id>
    <nct_id>NCT02207296</nct_id>
  </id_info>
  <brief_title>Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery</brief_title>
  <acronym>OPVI</acronym>
  <official_title>Operative Hemodynamic Optimization Using the Plethysmographic Variability Index During Orthopedic Surgery : a Multicentric Prospective Randomized Controlled Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Caen</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether an operative hemodynamic optimization using&#xD;
      the plethysmographic variability index during orthopedic surgery could decrease the length of&#xD;
      hospital stay and the postoperative morbidity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2015</start_date>
  <completion_date type="Actual">November 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</primary_completion_date>
  <phase>Phase 3</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of hospital stay after knee or hip arthroplasty</measure>
    <time_frame>Real length of hospital stay expressed as number of day (maximum 60 days)</time_frame>
    <description>Surgeons, blinded to the group allocation, are the postoperative care providers who decide the length of hospital stay.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Troponin value</measure>
    <time_frame>Postoperative Day 1 and Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Creatinine value</measure>
    <time_frame>Postoperative Day 1 and Day 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial Lactate</measure>
    <time_frame>1 hour after end of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative cardiac complications</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 week, until postoperative day 60</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Theorical length of hospital stay after knee or hip arthroplasty</measure>
    <time_frame>Theorical length of hospital stay expressed as number of day (maximum 60 days)</time_frame>
    <description>Evaluation twice per day starting day 3 until up day 60. A check list was used by an independant investigator to define the theorical date of end hospitalisation, from day 3 until day 60</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Medico economic evaluation</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 week, until postoperative day 60</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">440</enrollment>
  <condition>Hip Arthroplasty</condition>
  <condition>Knee Arthroplasty</condition>
  <condition>General Anesthesia</condition>
  <arm_group>
    <arm_group_label>PVI group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Fluid optimisation using PVI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Standard care using a hemodynamic protocol during general anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Plethysmographic variability index</intervention_name>
    <arm_group_label>PVI group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Indication to a knee or hip arthroplasty under general anesthesia&#xD;
&#xD;
          -  Sinusal rhythm&#xD;
&#xD;
        Non Inclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Black skin&#xD;
&#xD;
          -  Dialysis&#xD;
&#xD;
          -  Cardiac arrythmia&#xD;
&#xD;
          -  Sepsis&#xD;
&#xD;
          -  Use of another hemodynamic monitoring during surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Caen University Hospital</name>
      <address>
        <city>Caen</city>
        <zip>14 000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>June 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 4, 2014</study_first_posted>
  <last_update_submitted>May 14, 2019</last_update_submitted>
  <last_update_submitted_qc>May 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02207296
org study id: 2014-A00330-47
nct id: NCT02207296
lead sponsor: 
The purpose of this study is to determine whether an operative hemodynamic optimization using
      the plethysmographic variability index during orthopedic surgery could decrease the length of
      hospital stay and the postoperative morbidity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Length of hospital stay after knee or hip arthroplasty
time frame: Real length of hospital stay expressed as number of day (maximum 60 days)
description: Surgeons, blinded to the group allocation, are the postoperative care providers who decide the length of hospital stay.
measure: Troponin value
time frame: Postoperative Day 1 and Day 3
measure: Creatinine value
time frame: Postoperative Day 1 and Day 3
measure: Arterial Lactate
time frame: 1 hour after end of surgery
measure: Postoperative cardiac complications
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week, until postoperative day 60
measure: Theorical length of hospital stay after knee or hip arthroplasty
time frame: Theorical length of hospital stay expressed as number of day (maximum 60 days)
description: Evaluation twice per day starting day 3 until up day 60. A check list was used by an independant investigator to define the theorical date of end hospitalisation, from day 3 until day 60
measure: Medico economic evaluation
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 week, until postoperative day 60
arm group label: PVI group
arm group type: Other
description: Fluid optimisation using PVI
arm group label: Control group
arm group type: No Intervention
description: Standard care using a hemodynamic protocol during general anesthesia
intervention type: Device
intervention name: Plethysmographic variability index
arm group label: PVI group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor