<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/NCT03816514</url>
  </required_header>
  <id_info>
    <org_study_id>H-1811-039-986</org_study_id>
    <nct_id>NCT03816514</nct_id>
  </id_info>
  <brief_title>Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range</brief_title>
  <official_title>Use of Noninvasive Hemoglobin Monitoring for Maintaining Hemoglobin Concentration Within the Target Range During Major Surgery: A Randomized Controlled Trial</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>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this study is to evaluate whether pulse oximetry based noninvasive&#xD;
      hemoglobin (SpHb) monitoring can reduce the incidence of hemoglobin (Hb) level out of the&#xD;
      target range in adult patients undergoing major surgery with the potential risk of bleeding.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 4, 2019</start_date>
  <completion_date type="Actual">November 6, 2020</completion_date>
  <primary_completion_date type="Actual">November 2, 2020</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, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of deviation from the target hemoglobin range</measure>
    <time_frame>Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia</time_frame>
    <description>(The number of laboratory samples with the result hemoglobin concentrations were out of the target range)/(Total number of laboratory samples that performed during intra-operative periods)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The percentage extent of deviation from the target hemoglobin range</measure>
    <time_frame>Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia</time_frame>
    <description>The percentage extent of deviation of laboratory hemoglobin out of the prespecified target range</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Point-of-care (POC) sampling during surgery</measure>
    <time_frame>Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia</time_frame>
    <description>Number of Point-of-care (POC) sampling for measurement of hemoglobin concentration. In SpHb group, POC sampling will be done according to SpHb level. In control group, POC sampling will be done at discretion of anesthesiologist.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of the SpHb value</measure>
    <time_frame>Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia</time_frame>
    <description>Standard Laboratory hemoglobin measurement will be used as reference. Laboratory measurements will be done every 30 minute during surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients who receive intra-operative transfusion</measure>
    <time_frame>Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia</time_frame>
    <description>Number of patients who were transfused with pRBCs intraoperatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total volume of intravenous fluids given</measure>
    <time_frame>Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia</time_frame>
    <description>Total volume of intravenous fluids given intra-operatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total volume of pRBCs transfused</measure>
    <time_frame>Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia</time_frame>
    <description>Total volume of pRBCs transfused intra-operatively</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time for transfusion delay</measure>
    <time_frame>Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia</time_frame>
    <description>Time from the determination of transfusion to actual transfusion, in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of intraoperative hypotension</measure>
    <time_frame>Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia</time_frame>
    <description>hypotension is defined as SBP &lt; 80% of baseline SBP</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>laboratory total hemoglobin value, at postoperative day 1</measure>
    <time_frame>at postoperative day 1</time_frame>
    <description>total hemoglobin value measured by standard laboratory method</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Hemoglobins</condition>
  <condition>Blood Transfusion</condition>
  <condition>Hemorrhage</condition>
  <arm_group>
    <arm_group_label>SpHb monitoring group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In SpHb monitoring group, noninvasive, continuous SpHb monitoring will be done using Radical-7 pulse CO-Oximeter. The patients will be managed according to the prespecified protocol based on the SpHb values.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In control group, patients will receive conventional management without the SpHb monitoring. In these patients, the information about hemoglobin concentration of the patients will be obtained from hemoglobin measurement analyzed by point-of-care (POC) equipment, as usual standard care.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SpHb monitoring</intervention_name>
    <description>Noninvasive, continuous pulse oximetry-based hemoglobin (SpHb) monitoring</description>
    <arm_group_label>SpHb monitoring group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional management</intervention_name>
    <description>Conventional management without SpHb monitoring</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients with ASA physical status class I, II, III, who scheduled to undergo&#xD;
             elective non-cardiac major surgery with more than moderate risk of bleeding under&#xD;
             general anesthesia or spinal anesthesia.&#xD;
&#xD;
          -  Eligible Surgery include: Spine surgery, bone tumor surgery, Total Hip Replacement,&#xD;
             ovarian cancer surgery, cervical cancer surgery, radical cystectomy, open&#xD;
             retroperitoneal mass excision, Radical Retropubic Prostatectomy, explorative&#xD;
             laparotomy for abdominal mass excision, abdominal aortic aneurysm repair&#xD;
&#xD;
          -  Patients who are requiring an arterial catheter as a part of their standard care.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with preexisting deformity or skin condition that would impede sensor&#xD;
             placement&#xD;
&#xD;
          -  Patients with allergies to the adhesive sensor material&#xD;
&#xD;
          -  Patients with uncorrected preoperative anemia (preoperative hemoglobin &lt; 7 g/dL)&#xD;
&#xD;
          -  Patients who were not suitable for participation in the opinion of the study&#xD;
             investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jin-Tae Kim, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul national university hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Berkow L, Rotolo S, Mirski E. Continuous noninvasive hemoglobin monitoring during complex spine surgery. Anesth Analg. 2011 Dec;113(6):1396-402. doi: 10.1213/ANE.0b013e318230b425. Epub 2011 Sep 29.</citation>
    <PMID>21965372</PMID>
  </reference>
  <reference>
    <citation>Causey MW, Miller S, Foster A, Beekley A, Zenger D, Martin M. Validation of noninvasive hemoglobin measurements using the Masimo Radical-7 SpHb Station. Am J Surg. 2011 May;201(5):592-8. doi: 10.1016/j.amjsurg.2011.01.020.</citation>
    <PMID>21545905</PMID>
  </reference>
  <reference>
    <citation>Galvagno SM Jr, Hu P, Yang S, Gao C, Hanna D, Shackelford S, Mackenzie C. Accuracy of continuous noninvasive hemoglobin monitoring for the prediction of blood transfusions in trauma patients. J Clin Monit Comput. 2015 Dec;29(6):815-21. doi: 10.1007/s10877-015-9671-1. Epub 2015 Mar 10.</citation>
    <PMID>25753142</PMID>
  </reference>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>December 20, 2020</last_update_submitted>
  <last_update_submitted_qc>December 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Jin-Tae Kim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hemorrhage</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/NCT03816514
org study id: H-1811-039-986
nct id: NCT03816514
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The primary aim of this study is to evaluate whether pulse oximetry based noninvasive
      hemoglobin (SpHb) monitoring can reduce the incidence of hemoglobin (Hb) level out of the
      target range in adult patients undergoing major surgery with the potential risk of bleeding.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: The incidence of deviation from the target hemoglobin range
time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
description: (The number of laboratory samples with the result hemoglobin concentrations were out of the target range)/(Total number of laboratory samples that performed during intra-operative periods)
measure: The percentage extent of deviation from the target hemoglobin range
time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
description: The percentage extent of deviation of laboratory hemoglobin out of the prespecified target range
measure: Number of Point-of-care (POC) sampling during surgery
time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
description: Number of Point-of-care (POC) sampling for measurement of hemoglobin concentration. In SpHb group, POC sampling will be done according to SpHb level. In control group, POC sampling will be done at discretion of anesthesiologist.
measure: Accuracy of the SpHb value
time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
description: Standard Laboratory hemoglobin measurement will be used as reference. Laboratory measurements will be done every 30 minute during surgery
measure: Number of patients who receive intra-operative transfusion
time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
description: Number of patients who were transfused with pRBCs intraoperatively
measure: Total volume of intravenous fluids given
time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
description: Total volume of intravenous fluids given intra-operatively
measure: Total volume of pRBCs transfused
time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
description: Total volume of pRBCs transfused intra-operatively
measure: Time for transfusion delay
time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
description: Time from the determination of transfusion to actual transfusion, in minutes
measure: Incidence of intraoperative hypotension
time frame: Until transfer to PACU (Post-Anesthesia Care Unit), from the beginning of the induction of anesthesia
description: hypotension is defined as SBP < 80% of baseline SBP
measure: laboratory total hemoglobin value, at postoperative day 1
time frame: at postoperative day 1
description: total hemoglobin value measured by standard laboratory method
arm group label: SpHb monitoring group
arm group type: Experimental
description: In SpHb monitoring group, noninvasive, continuous SpHb monitoring will be done using Radical-7 pulse CO-Oximeter. The patients will be managed according to the prespecified protocol based on the SpHb values.
arm group label: Control group
arm group type: Active Comparator
description: In control group, patients will receive conventional management without the SpHb monitoring. In these patients, the information about hemoglobin concentration of the patients will be obtained from hemoglobin measurement analyzed by point-of-care (POC) equipment, as usual standard care.
intervention type: Procedure
intervention name: SpHb monitoring
description: Noninvasive, continuous pulse oximetry-based hemoglobin (SpHb) monitoring
arm group label: SpHb monitoring group
intervention type: Procedure
intervention name: Conventional management
description: Conventional management without SpHb monitoring
arm group label: Control group
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Jin-Tae Kim, MD, PhD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
citation: Berkow L, Rotolo S, Mirski E. Continuous noninvasive hemoglobin monitoring during complex spine surgery. Anesth Analg. 2011 Dec;113(6):1396-402. doi: 10.1213/ANE.0b013e318230b425. Epub 2011 Sep 29.
PMID: 21965372
citation: Causey MW, Miller S, Foster A, Beekley A, Zenger D, Martin M. Validation of noninvasive hemoglobin measurements using the Masimo Radical-7 SpHb Station. Am J Surg. 2011 May;201(5):592-8. doi: 10.1016/j.amjsurg.2011.01.020.
PMID: 21545905
citation: Galvagno SM Jr, Hu P, Yang S, Gao C, Hanna D, Shackelford S, Mackenzie C. Accuracy of continuous noninvasive hemoglobin monitoring for the prediction of blood transfusions in trauma patients. J Clin Monit Comput. 2015 Dec;29(6):815-21. doi: 10.1007/s10877-015-9671-1. Epub 2015 Mar 10.
PMID: 25753142
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Jin-Tae Kim
investigator title: Professor
mesh term: Hemorrhage