<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/NCT04506957</url>
  </required_header>
  <id_info>
    <org_study_id>Pulse-CO Oximetry Hemoglobin</org_study_id>
    <nct_id>NCT04506957</nct_id>
  </id_info>
  <brief_title>Non-invasive Continuous Total Hemoglobin Measurement by Pulse CO-Oximetry</brief_title>
  <acronym>SpHb</acronym>
  <official_title>Non-invasive Continuous Total Hemoglobin Measurement by Pulse CO-Oximetry in Major Spine Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Klinik Hirslanden, Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Klinik Hirslanden, Zurich</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a data collection/sampling project for transcutaneous continuous Pulse&#xD;
      CO-Oximetry and accessories (SW-Version Radical-7® Pulse CO-Oximeter with the Masimo rainbow&#xD;
      SETTM, V1.6.2.4i Masimo Corp., Irvine, CA, USA, and the RD rainbow SET-2, Rev-O&#xD;
      Fingersensor). The device received the CE Mark in 2012 and is approved by the Swiss Medic for&#xD;
      clinical use. The Radical-7 device isolates multiple (7+) wavelengths of light of arterial&#xD;
      signals using adaptive filters. It provides continuous noninvasive monitoring of arterial&#xD;
      oxygen saturation (RadSpO2), pulse rate (RadPR), carboxyhaemoglobin saturation (SpCO),&#xD;
      methaemoglobin saturation (SpMET), total haemoglobin concentration in g/dl (SpHb) and/or&#xD;
      respiration rate (RRa). Additionally, Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth&#xD;
      Variability Index (PVI), total arterial oxygen content (SpOC), Haematocrit (SpHCT), Signal&#xD;
      identification Quality (SIQa), Respiration Indicator (RI) are displayed.The purpose of this&#xD;
      prospective study is to investigate the reliability of non-invasive continuously measured&#xD;
      SpHb by the Masimo Radical-7® Pulse co-oximeter (Radical 7 device) under steady state&#xD;
      conditions by comparison against simultaneously invasive measured arterial haemoglobin&#xD;
      concentrations (CoOxHb) in major spine surgery patients, in which high blood loss was&#xD;
      expected&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of this investigation is the comparison of CoOxHb, HCT and SaO2 values of a&#xD;
      blood gas analyzer (ABL 825, Radiometer Medical A/S) with simultaneously measured SpHb values&#xD;
      of the Radical 7 device during the procedure of major spine surgery.&#xD;
&#xD;
      The primary endpoint of the study is the reliability of SpHb to detect CoOxHb and its changes&#xD;
      during the process Secondary endpoint is the reliability of RadSpO2, RadPR, SpHCT and SpMET&#xD;
      to detect SaO2, PR, HCT and MetHb and its changes during the process.&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        1. Patients scheduled for major spine surger&#xD;
&#xD;
        2. Age 18 years and older&#xD;
&#xD;
        3. Written consent of the participation after clarification about the study&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        1. No consent to participate&#xD;
&#xD;
        2. No German comprehension&#xD;
&#xD;
        3. Black skin patients&#xD;
&#xD;
        4. Patients with COVID-19 illness All patients were monitored based on the institutional&#xD;
           routine monitoring for major spine surgery (continuous 2-channel electrocardiogram, a&#xD;
           continuous invasive arterial blood pressure monitoring via fluid-filled cather system,&#xD;
           inserted in the radial artery mainly of the non-dominant hand, SpO2, and in the case of&#xD;
           high-risk patient a triple-lumen central venous line). Then a single use finger sensor&#xD;
           (MasimoSet RD rainbow SET SpHb SpMet-Sensor) is attahed to the ring finger of the hand,&#xD;
           where the catheter is introduced in the radial artery.&#xD;
&#xD;
      During the surgery routinely, arterial blood samples are drawn before induction of&#xD;
      Anaesthesia, every 45 min and after acute blood loss during surgery. With each blood sample&#xD;
      for a blood gas analysis the SpHb, SpMet, PI, PVI and the low SQI are recorded.&#xD;
&#xD;
      No additional blood sampling is necessary to perfom this investigation&#xD;
&#xD;
      50 patients will be included and the duration of the study is 24 month's Sample size&#xD;
      calculation was performed with the StatsDirect Statistical Software Version 2.8.0 2013&#xD;
      (StatsDirect Ltd, Altrincham, UK) and revealed a sample size of 95 paired SpHb and CoOxHb&#xD;
      measurements to achieve a power of 0.9, α = 0.05 to detect a mean difference (bias) of CoOxHb&#xD;
      and SpHb of 0.50 g/dl with an estimated standard deviation (SD) of 1.0g/dl. The mean&#xD;
      difference is determined based on previous investigations. Continuous variables are tested&#xD;
      for normal distribution with the Kolmogorov-Smirnow test. Normally distributed data are&#xD;
      expressed as mean ± standard deviation (SD); median, interquartile range (IQR ; 25th to 75th&#xD;
      percentile) and [maximum] are specified when the data were not normally distributed.&#xD;
      Categorical variables are presented as number and percentage (%). For subgroup analysis&#xD;
      continuous variables are compared using the t-test or Mann-Whitney U test, when appropriate.&#xD;
      All tests are two-sided and a P-value &lt; 0.05 was determined to be significant.&#xD;
&#xD;
      For all determinants that might have an impact on the fault detection of the SpHb stepwise&#xD;
      multiple regressions analysis was performed. Correlation is evaluated by Spearman rank test.&#xD;
      To determine agreement of the methods, the Bland Altman analysis for repeated measurements is&#xD;
      performed for SpHb and CoOcHb.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Years</target_duration>
  <primary_outcome>
    <measure>Reliability of SpHb to detect CoOxHb and its changes</measure>
    <time_frame>24 months</time_frame>
    <description>Co-oximetry hemoglobin values from blood gas analyzer is simultaneous compared with the transcutaneous detected SpHb (Pulse CO-Oximetry hemoglobin measurement). Linear correlation and Bland Altman Analysis are performed for analysis these data pairs</description>
  </primary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Transcutaneous Continuous Hemoglobin Measurement</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulse CO-Oximetry Hemoglobin measurement transcutaneous</intervention_name>
    <description>this is an observational Investigation, in which transcutaneous continuous hemoglobin detection using Pulse-CO-Oximetry is compared with co-oximetrically measured Hemoglobin using a blood gas analyzer device</description>
    <other_name>interventions are only performed based on co-oximetry hemoglobin measurement using a blood gas analyzer</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients scheduled for major spine surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for major spine surgery&#xD;
&#xD;
          -  Written consent of the participation after clarification about the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. No consent to participate&#xD;
&#xD;
          2. No German comprehension&#xD;
&#xD;
          3. Black skin patients&#xD;
&#xD;
          4. Patients with COVID-19 illness&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Werner Baulig, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinik Im Park</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Werner Baulig, MD</last_name>
    <phone>+41442092875</phone>
    <email>werner.baulig@hirslanden.ch</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kan Min, MD</last_name>
    <phone>+41442092111</phone>
    <email>kan.min@hirslanden.ch</email>
  </overall_contact_backup>
  <reference>
    <citation>Baulig W, Seifert B, Spahn DR, Theusinger OM. Accuracy of non-invasive continuous total hemoglobin measurement by Pulse CO-Oximetry in severe traumatized and surgical bleeding patients. J Clin Monit Comput. 2017 Feb;31(1):177-185. doi: 10.1007/s10877-015-9816-2. Epub 2015 Dec 19.</citation>
    <PMID>26686689</PMID>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 7, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>September 2, 2020</last_update_submitted>
  <last_update_submitted_qc>September 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Klinik Hirslanden, Zurich</investigator_affiliation>
    <investigator_full_name>Werner Baulig</investigator_full_name>
    <investigator_title>Prof. Dr. med. Werner Baulig</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chrysarobin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>it is not planned to make individual participant data available to other researchers</ipd_description>
  </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/NCT04506957
org study id: Pulse-CO Oximetry Hemoglobin
nct id: NCT04506957
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
This study is a data collection/sampling project for transcutaneous continuous Pulse
      CO-Oximetry and accessories (SW-Version Radical-7® Pulse CO-Oximeter with the Masimo rainbow
      SETTM, V1.6.2.4i Masimo Corp., Irvine, CA, USA, and the RD rainbow SET-2, Rev-O
      Fingersensor). The device received the CE Mark in 2012 and is approved by the Swiss Medic for
      clinical use. The Radical-7 device isolates multiple (7+) wavelengths of light of arterial
      signals using adaptive filters. It provides continuous noninvasive monitoring of arterial
      oxygen saturation (RadSpO2), pulse rate (RadPR), carboxyhaemoglobin saturation (SpCO),
      methaemoglobin saturation (SpMET), total haemoglobin concentration in g/dl (SpHb) and/or
      respiration rate (RRa). Additionally, Low Signal IQ (Low SIQ), Perfusion Index (PI), Pleth
      Variability Index (PVI), total arterial oxygen content (SpOC), Haematocrit (SpHCT), Signal
      identification Quality (SIQa), Respiration Indicator (RI) are displayed.The purpose of this
      prospective study is to investigate the reliability of non-invasive continuously measured
      SpHb by the Masimo Radical-7® Pulse co-oximeter (Radical 7 device) under steady state
      conditions by comparison against simultaneously invasive measured arterial haemoglobin
      concentrations (CoOxHb) in major spine surgery patients, in which high blood loss was
      expected
The objective of this investigation is the comparison of CoOxHb, HCT and SaO2 values of a
      blood gas analyzer (ABL 825, Radiometer Medical A/S) with simultaneously measured SpHb values
      of the Radical 7 device during the procedure of major spine surgery.

      The primary endpoint of the study is the reliability of SpHb to detect CoOxHb and its changes
      during the process Secondary endpoint is the reliability of RadSpO2, RadPR, SpHCT and SpMET
      to detect SaO2, PR, HCT and MetHb and its changes during the process.

      Inclusion criteria:

        1. Patients scheduled for major spine surger

        2. Age 18 years and older

        3. Written consent of the participation after clarification about the study

      Exclusion criteria:

        1. No consent to participate

        2. No German comprehension

        3. Black skin patients

        4. Patients with COVID-19 illness All patients were monitored based on the institutional
           routine monitoring for major spine surgery (continuous 2-channel electrocardiogram, a
           continuous invasive arterial blood pressure monitoring via fluid-filled cather system,
           inserted in the radial artery mainly of the non-dominant hand, SpO2, and in the case of
           high-risk patient a triple-lumen central venous line). Then a single use finger sensor
           (MasimoSet RD rainbow SET SpHb SpMet-Sensor) is attahed to the ring finger of the hand,
           where the catheter is introduced in the radial artery.

      During the surgery routinely, arterial blood samples are drawn before induction of
      Anaesthesia, every 45 min and after acute blood loss during surgery. With each blood sample
      for a blood gas analysis the SpHb, SpMet, PI, PVI and the low SQI are recorded.

      No additional blood sampling is necessary to perfom this investigation

      50 patients will be included and the duration of the study is 24 month's Sample size
      calculation was performed with the StatsDirect Statistical Software Version 2.8.0 2013
      (StatsDirect Ltd, Altrincham, UK) and revealed a sample size of 95 paired SpHb and CoOxHb
      measurements to achieve a power of 0.9, α = 0.05 to detect a mean difference (bias) of CoOxHb
      and SpHb of 0.50 g/dl with an estimated standard deviation (SD) of 1.0g/dl. The mean
      difference is determined based on previous investigations. Continuous variables are tested
      for normal distribution with the Kolmogorov-Smirnow test. Normally distributed data are
      expressed as mean ± standard deviation (SD); median, interquartile range (IQR ; 25th to 75th
      percentile) and [maximum] are specified when the data were not normally distributed.
      Categorical variables are presented as number and percentage (%). For subgroup analysis
      continuous variables are compared using the t-test or Mann-Whitney U test, when appropriate.
      All tests are two-sided and a P-value < 0.05 was determined to be significant.

      For all determinants that might have an impact on the fault detection of the SpHb stepwise
      multiple regressions analysis was performed. Correlation is evaluated by Spearman rank test.
      To determine agreement of the methods, the Bland Altman analysis for repeated measurements is
      performed for SpHb and CoOcHb.
observational model: Case-Only
time perspective: Prospective
measure: Reliability of SpHb to detect CoOxHb and its changes
time frame: 24 months
description: Co-oximetry hemoglobin values from blood gas analyzer is simultaneous compared with the transcutaneous detected SpHb (Pulse CO-Oximetry hemoglobin measurement). Linear correlation and Bland Altman Analysis are performed for analysis these data pairs
intervention type: Device
intervention name: Pulse CO-Oximetry Hemoglobin measurement transcutaneous
description: this is an observational Investigation, in which transcutaneous continuous hemoglobin detection using Pulse-CO-Oximetry is compared with co-oximetrically measured Hemoglobin using a blood gas analyzer device
other name: interventions are only performed based on co-oximetry hemoglobin measurement using a blood gas analyzer
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Werner Baulig, MD
role: Principal Investigator
affiliation: Klinik Im Park
last name: Werner Baulig, MD
phone: +41442092875
email: werner.baulig@hirslanden.ch
last name: Kan Min, MD
phone: +41442092111
email: kan.min@hirslanden.ch
citation: Baulig W, Seifert B, Spahn DR, Theusinger OM. Accuracy of non-invasive continuous total hemoglobin measurement by Pulse CO-Oximetry in severe traumatized and surgical bleeding patients. J Clin Monit Comput. 2017 Feb;31(1):177-185. doi: 10.1007/s10877-015-9816-2. Epub 2015 Dec 19.
PMID: 26686689
responsible party type: Principal Investigator
investigator affiliation: Klinik Hirslanden, Zurich
investigator full name: Werner Baulig
investigator title: Prof. Dr. med. Werner Baulig
mesh term: Chrysarobin
sharing ipd: No
ipd description: it is not planned to make individual participant data available to other researchers