<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/NCT01693016</url>
  </required_header>
  <id_info>
    <org_study_id>MASIMO 2012</org_study_id>
    <nct_id>NCT01693016</nct_id>
  </id_info>
  <brief_title>Validation of Non-invasive Hemoglobin (SpHb) Measurement in Children</brief_title>
  <official_title>Validation of Non-invasive Hb-measurement (SpHb) in Children With the Masimo@ Radical 7</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johannes Gutenberg University Mainz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johannes Gutenberg University Mainz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the value of the new technique of non-invasive&#xD;
      measurement of Hb in children undergoing a surgical procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Several surgical procedures require haemoglobin monitoring due to possible blood loss and the&#xD;
      need of blood transfusion. The standard for monitoring hemoglobin (Hb) is the measurement of&#xD;
      blood samples. The novel technique of non-invasive continuous measurement of Hb using Pulse&#xD;
      CO-Oximetry may allow measuring Hb without obtaining blood samples.&#xD;
&#xD;
      This new technique has not been tested yet in children undergoing anesthesia for elective&#xD;
      surgical procedures. In this study the investigators compare the non-invasive Hb measurement&#xD;
      with Masimo® technology (SpHb) with the standard Hb measurement using ABL-800 Flex (BGA) and&#xD;
      Siemens Advia (labHb, reference method) before the children undergo the surgical procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>correlation between SpHb(®) and the Hb measured by the ABL800Flex and the Siemens Advia</measure>
    <time_frame>one day</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>influence of inhalation anesthetics</measure>
    <time_frame>one day</time_frame>
    <description>The blood samples are taken from the needle infusion set the child gets for anesthesia. Some children will need an inhalational induction of anesthesia before they can get the needle and the sensor for the SpHb (®) monitoring. So an influence of the application of inhalation anesthetics on the accuracy of the SpHb (®) will be tested.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">81</enrollment>
  <condition>Non-invasive Hb Measurement in Children</condition>
  <arm_group>
    <arm_group_label>inhalation group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>20 children Taking blood samples and SpHb-measurement was made under inhalational anesthesia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-inhalational</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>40 children Taking blood samples and SpHb measurements in awake and spontaneous breathing children.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>non-invasive measurement of Hb</intervention_name>
    <arm_group_label>inhalation group</arm_group_label>
    <arm_group_label>non-inhalational</arm_group_label>
    <other_name>SpHb (®) by Masimo ® Radical 7</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>taking blood samples</intervention_name>
    <arm_group_label>inhalation group</arm_group_label>
    <arm_group_label>non-inhalational</arm_group_label>
    <other_name>blood for BGA (ABL 800)</other_name>
    <other_name>blood for laboratory Hb (Siemens Advia)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children (&gt;= 3 kg until 8 years)&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
          -  written informed consent of legal representative&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children &lt;= 3kg or &gt; 8 years&#xD;
&#xD;
          -  emergency surgery&#xD;
&#xD;
          -  allergy against sensor of SpHb(®)&#xD;
&#xD;
          -  artery occlusive disease&#xD;
&#xD;
          -  sepsis&#xD;
&#xD;
          -  haemoglobinopathy&#xD;
&#xD;
          -  specific medical or psychological circumstances which do not allow the consent of the&#xD;
             legal representative or the performance of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eva Wittenmeier</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johannes Gutenberg University Mainz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dr. Eva Wittenmeier</name>
      <address>
        <city>Mainz</city>
        <zip>55131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>September 19, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>March 23, 2014</last_update_submitted>
  <last_update_submitted_qc>March 23, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 26, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Johannes Gutenberg University Mainz</investigator_affiliation>
    <investigator_full_name>Dr. Eva Wittenmeier</investigator_full_name>
    <investigator_title>Dr. Eva Wittenmeier</investigator_title>
  </responsible_party>
  <keyword>non-invasive Hb measurement in children</keyword>
  <!-- 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/NCT01693016
org study id: MASIMO 2012
nct id: NCT01693016
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the value of the new technique of non-invasive
      measurement of Hb in children undergoing a surgical procedure.
Several surgical procedures require haemoglobin monitoring due to possible blood loss and the
      need of blood transfusion. The standard for monitoring hemoglobin (Hb) is the measurement of
      blood samples. The novel technique of non-invasive continuous measurement of Hb using Pulse
      CO-Oximetry may allow measuring Hb without obtaining blood samples.

      This new technique has not been tested yet in children undergoing anesthesia for elective
      surgical procedures. In this study the investigators compare the non-invasive Hb measurement
      with Masimo® technology (SpHb) with the standard Hb measurement using ABL-800 Flex (BGA) and
      Siemens Advia (labHb, reference method) before the children undergo the surgical procedure.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: correlation between SpHb(®) and the Hb measured by the ABL800Flex and the Siemens Advia
time frame: one day
measure: influence of inhalation anesthetics
time frame: one day
description: The blood samples are taken from the needle infusion set the child gets for anesthesia. Some children will need an inhalational induction of anesthesia before they can get the needle and the sensor for the SpHb (®) monitoring. So an influence of the application of inhalation anesthetics on the accuracy of the SpHb (®) will be tested.
arm group label: inhalation group
arm group type: Other
description: 20 children Taking blood samples and SpHb-measurement was made under inhalational anesthesia
arm group label: non-inhalational
arm group type: Other
description: 40 children Taking blood samples and SpHb measurements in awake and spontaneous breathing children.
intervention type: Device
intervention name: non-invasive measurement of Hb
arm group label: inhalation group
arm group label: non-inhalational
other name: SpHb (®) by Masimo ® Radical 7
intervention type: Procedure
intervention name: taking blood samples
arm group label: inhalation group
arm group label: non-inhalational
other name: blood for BGA (ABL 800)
other name: blood for laboratory Hb (Siemens Advia)
criteria: 
gender: All
minimum age: N/A
maximum age: 8 Years
healthy volunteers: No
last name: Eva Wittenmeier
role: Principal Investigator
affiliation: Johannes Gutenberg University Mainz
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Johannes Gutenberg University Mainz
investigator full name: Dr. Eva Wittenmeier
investigator title: Dr. Eva Wittenmeier