<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/NCT01706276</url>
  </required_header>
  <id_info>
    <org_study_id>TJMZK20120902</org_study_id>
    <nct_id>NCT01706276</nct_id>
  </id_info>
  <brief_title>MASIMO Radical 7 and Laboratory Measurement</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huazhong University of Science and Technology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huazhong University of Science and Technology</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Present study aimed to evaluate the accuracy of Masimo Radical 7 to monitor hemoglobin&#xD;
      concentrations through compared with laboratory measurement during major hepatic surgery, and&#xD;
      to determine the source of discordance between two methods.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">July 2013</completion_date>
  <primary_completion_date type="Actual">April 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hemoglobin measurement using the Masimo device</measure>
    <time_frame>0.5h after skin incision</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Hemoglobin measurement using the Masimo device</measure>
    <time_frame>1h and 3h after skin incision</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">225</enrollment>
  <condition>Major Hepatic Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients, American Society of Anesthesiologists Physical Status Ⅰor Ⅱ, scheduled for&#xD;
        potentially hemorrhagic major hepatic resection under general anesthesia and requiring an&#xD;
        arterial line&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients&#xD;
&#xD;
          -  American Society of Anesthesiologists Physical Status Ⅰor Ⅱ&#xD;
&#xD;
          -  scheduled for potentially hemorrhagic major hepatic resection under general anesthesia&#xD;
&#xD;
          -  requiring an arterial line&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  coagulopathy&#xD;
&#xD;
          -  hemoglobinopathy&#xD;
&#xD;
          -  cardiac dysrhythmias&#xD;
&#xD;
          -  arrhythmia&#xD;
&#xD;
          -  intracardiac shunt&#xD;
&#xD;
          -  heart valve diseases&#xD;
&#xD;
          -  tinea unguium&#xD;
&#xD;
          -  arterio puncture failure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yuke Tian, MD.</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2013</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2012</study_first_posted>
  <last_update_submitted>November 19, 2013</last_update_submitted>
  <last_update_submitted_qc>November 19, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 20, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
    <investigator_full_name>Wei Mei</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </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/NCT01706276
org study id: TJMZK20120902
nct id: NCT01706276
lead sponsor: 
has dmc: Yes
Present study aimed to evaluate the accuracy of Masimo Radical 7 to monitor hemoglobin
      concentrations through compared with laboratory measurement during major hepatic surgery, and
      to determine the source of discordance between two methods.
observational model: Cohort
time perspective: Retrospective
measure: Hemoglobin measurement using the Masimo device
time frame: 0.5h after skin incision
measure: Change of Hemoglobin measurement using the Masimo device
time frame: 1h and 3h after skin incision
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yuke Tian, MD.
role: Study Chair
affiliation: Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Huazhong University of Science and Technology
investigator full name: Wei Mei
investigator title: Associate Professor