<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/NCT02980471</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00049209</org_study_id>
    <nct_id>NCT02980471</nct_id>
  </id_info>
  <brief_title>Comparison of Compensatory Reserve Index to Changes in Stroke Volume and Intravascular Volume</brief_title>
  <official_title>Comparison of Compensatory Reserve Index to Changes in Stroke Volume and Intravascular Volume</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Flashback Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Flashback Technologies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate the correlation of the Compensatory Reserve Index&#xD;
      (CRI) numeric and graphical trend readings to intravascular volume changes as compared to&#xD;
      graded blood loss (removal of 20% of estimated total blood volume in ~333 mL aliquots) and to&#xD;
      stroke volume as measured by the Nexfin monitor during the same graded blood removal period.&#xD;
      Enrollment includes both men and women.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sequential Blood Loss: Blood loss will be simulated by withdrawal of 20% of estimated total&#xD;
      blood volume. Estimated total blood volume for men = 75 mL/kg and for women = 65 mL/kg. The&#xD;
      calculated target withdrawal volume is also consistent with an allowable estimated blood loss&#xD;
      equation assuming a starting hematocrit (hct) of approximately 45% in males and 40% in&#xD;
      females, where the expected drop in hct for this volume withdrawn is 7 percentage points in&#xD;
      males and 6 percentage points in females. An actual drop in hct may not be observed in this&#xD;
      study due to the relatively expedient removal of blood and no simultaneous administration of&#xD;
      fluids (i.e., no &quot;hemodilution&quot; with crystalloid). Blood will be removed in aliquots up to&#xD;
      ~333 mL. For safety, men will have no more than 4 units of blood removed (1,333 mL) and women&#xD;
      will have no more than 3 units of blood removed (1,000 mL).&#xD;
&#xD;
      The blood will be withdrawn via the venous catheter and we anticipate that it will take 15-20&#xD;
      min for each stage of blood withdrawal to occur. A total of 3 aliquots will be withdrawn over&#xD;
      approximately sixty minutes in women and 4 aliquots withdrawn over 80 minutes in men. The&#xD;
      blood will be stored using preservatives and anticoagulation procedures similar to those used&#xD;
      for perioperative hemodilution and/or intraoperative cell saver. The blood will remain in the&#xD;
      study room until it is re-infused. We will use standard &quot;auto-transfusion&quot; blood collection&#xD;
      equipment identical to that used in the ORs for perioperative hemodilution techniques. The&#xD;
      blood will be drained by gravity from an indwelling vascular catheter into anti-coagulant&#xD;
      preservative solution using tubing and bags systems provided by the autologous transfusion&#xD;
      team that we routinely work with in the ORs. For the first several studies we will schedule&#xD;
      them at a time when auto-transfusion OR personnel can be present and after that the&#xD;
      anesthesiologists will be directly involved in drawing the blood, subsequent handling and&#xD;
      reinfusion. The blood will never leave the autologous transfusion bag and a closed system&#xD;
      will be used. The blood will be held at room temp with gentle agitation for ~60-80 minutes&#xD;
      and then re-infused over 60-80 minutes via a large bore IV; monitoring will continue during&#xD;
      reinfusion. Following completion of the reinfusion subjects will de-instrumented and observed&#xD;
      in the physiology lab for two hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison of CipherOx trend to blood removal for trending intravascular volume</measure>
    <time_frame>1 hour</time_frame>
    <description>comparison of CipherOx reading trend before removal of blood, post 330mL, 660mL and 1,000mL blood removal for trending intravascular volume change</description>
  </primary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Hemorrhage</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulse Oximeter</intervention_name>
    <description>Blood removal and reintroduction as measured by the plethysmograph of a pulse oximeter</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Twenty healthy volunteers between the ages of 18 and 55, men and women, American Society of&#xD;
        Anesthesiology &quot;class 1&quot; health status.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Ages 18-55.&#xD;
&#xD;
               -  Physical status: Healthy ASA Class 1.&#xD;
&#xD;
               -  Male or female.&#xD;
&#xD;
               -  Screening hemoglobin &gt; 13.5 g/dl and hematocrit &gt; 39% for males&#xD;
&#xD;
               -  Screening hemoglobin &gt; 12 g/dl and hematocrit &gt; 35% for females&#xD;
&#xD;
               -  BMI &lt;30&#xD;
&#xD;
               -  Ability to provide written informed consent.&#xD;
&#xD;
               -  Willing and able to comply with study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Subjects with injuries, deformities or abnormalities that may prevent proper&#xD;
             application of the device under test&#xD;
&#xD;
               -  Subjects with known respiratory conditions (uncontrolled asthma, head cold, flu,&#xD;
                  pneumonia / bronchitis, respiratory distress / respiratory or lung surgery,&#xD;
                  emphysema, COPD, lung disease),&#xD;
&#xD;
               -  Subjects with history of cardiovascular disease, hypertension, diabetes or any&#xD;
                  other diseases/conditions that might negatively influence their ability to&#xD;
                  tolerate moderate but temporary blood loss.&#xD;
&#xD;
               -  Obese subjects (BMI&gt;30)&#xD;
&#xD;
               -  Smoker.&#xD;
&#xD;
               -  Subjects on drugs of any type (except oral contraceptives).&#xD;
&#xD;
               -  Female subjects that are actively trying to get pregnant or are pregnant.&#xD;
&#xD;
               -  Subjects taking blood thinners or medications with antiplatelet factors.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 30, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>December 1, 2016</last_update_submitted>
  <last_update_submitted_qc>December 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</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/NCT02980471
org study id: Pro00049209
nct id: NCT02980471
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to demonstrate the correlation of the Compensatory Reserve Index
      (CRI) numeric and graphical trend readings to intravascular volume changes as compared to
      graded blood loss (removal of 20% of estimated total blood volume in ~333 mL aliquots) and to
      stroke volume as measured by the Nexfin monitor during the same graded blood removal period.
      Enrollment includes both men and women.
Sequential Blood Loss: Blood loss will be simulated by withdrawal of 20% of estimated total
      blood volume. Estimated total blood volume for men = 75 mL/kg and for women = 65 mL/kg. The
      calculated target withdrawal volume is also consistent with an allowable estimated blood loss
      equation assuming a starting hematocrit (hct) of approximately 45% in males and 40% in
      females, where the expected drop in hct for this volume withdrawn is 7 percentage points in
      males and 6 percentage points in females. An actual drop in hct may not be observed in this
      study due to the relatively expedient removal of blood and no simultaneous administration of
      fluids (i.e., no "hemodilution" with crystalloid). Blood will be removed in aliquots up to
      ~333 mL. For safety, men will have no more than 4 units of blood removed (1,333 mL) and women
      will have no more than 3 units of blood removed (1,000 mL).

      The blood will be withdrawn via the venous catheter and we anticipate that it will take 15-20
      min for each stage of blood withdrawal to occur. A total of 3 aliquots will be withdrawn over
      approximately sixty minutes in women and 4 aliquots withdrawn over 80 minutes in men. The
      blood will be stored using preservatives and anticoagulation procedures similar to those used
      for perioperative hemodilution and/or intraoperative cell saver. The blood will remain in the
      study room until it is re-infused. We will use standard "auto-transfusion" blood collection
      equipment identical to that used in the ORs for perioperative hemodilution techniques. The
      blood will be drained by gravity from an indwelling vascular catheter into anti-coagulant
      preservative solution using tubing and bags systems provided by the autologous transfusion
      team that we routinely work with in the ORs. For the first several studies we will schedule
      them at a time when auto-transfusion OR personnel can be present and after that the
      anesthesiologists will be directly involved in drawing the blood, subsequent handling and
      reinfusion. The blood will never leave the autologous transfusion bag and a closed system
      will be used. The blood will be held at room temp with gentle agitation for ~60-80 minutes
      and then re-infused over 60-80 minutes via a large bore IV; monitoring will continue during
      reinfusion. Following completion of the reinfusion subjects will de-instrumented and observed
      in the physiology lab for two hours.
observational model: Case-Only
time perspective: Prospective
measure: Comparison of CipherOx trend to blood removal for trending intravascular volume
time frame: 1 hour
description: comparison of CipherOx reading trend before removal of blood, post 330mL, 660mL and 1,000mL blood removal for trending intravascular volume change
intervention type: Device
intervention name: Pulse Oximeter
description: Blood removal and reintroduction as measured by the plethysmograph of a pulse oximeter
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Hemorrhage
sharing ipd: No