<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/NCT03248830</url>
  </required_header>
  <id_info>
    <org_study_id>N-99-2017</org_study_id>
    <nct_id>NCT03248830</nct_id>
  </id_info>
  <brief_title>Non-invasive Hemoglobin Monitoring in Congenital Heart Diseased Children</brief_title>
  <official_title>Evaluation of Non-invasive Hemoglobin Monitoring in Children With Congenital Heart Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will evaluate the accuracy of non-invasive hemoglobin monitor (Sp-Hb)&#xD;
      compared to traditional laboratory hemoglobin (Lab-Hb) in children with congenital heart&#xD;
      disease. The investigators will also compare the accuracy of Sp-Hb in cyanotic children to&#xD;
      acyanotic children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Blood hemoglobin is measured daily in clinical practice. Laboratory measurement (Lab-Hb) of&#xD;
      is the gold standard for assessment of blood hemoglobin. Recently, non-invasive monitors had&#xD;
      been introduced. Non-invasive measurement of hemoglobin (Sp-Hb) would save time and minimize&#xD;
      the risk of infection. Blood sampling in children is usually more difficult and stressful;&#xD;
      moreover, it also carries the risk of iatrogenic anemia.&#xD;
&#xD;
      Radical-7 (Masimo corporation, Irvine, CA) is a device that operates using the principle of&#xD;
      co-oximetry . Radical-7 had been validated in various clinical purposes. Measurement of blood&#xD;
      hemoglobin is an important application for Radical-7 device. Non-invasive hemoglobin (Sp-Hb)&#xD;
      measurement has been frequently validated in adults; as well as in pediatric patients;&#xD;
      however, its accuracy in children with congenital heart disease was not investigated.&#xD;
      Congenital heart disease infants usually undergo major operations and frequently need&#xD;
      transfusion of blood. Moreover, these patients have special circulatory physiology that might&#xD;
      impact the device accuracy. It had been recently reported that the performance of co-oximetry&#xD;
      in congenital heart disease children is poor in measurement of oxygen saturation specially at&#xD;
      oxygen saturation under 75%; however, its accuracy in measurement of hemoglobin was not&#xD;
      investigated yet. In this study, the investigators will evaluate the accuracy of Sp-Hb&#xD;
      compared to traditional Lab-Hb in children with congenital heart disease. the investigators&#xD;
      will also compare the accuracy of Sp-Hb in cyanotic children to acyanotic children.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2018</start_date>
  <completion_date type="Actual">September 10, 2019</completion_date>
  <primary_completion_date type="Actual">August 1, 2019</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>non-invasive hemoglobin</measure>
    <time_frame>5 hours</time_frame>
    <description>the value of hemoglobin measured by radical-7 device in g/dL</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>laboratory hemoglobin</measure>
    <time_frame>5 hours</time_frame>
    <description>the value of hemoglobin measured from a blood sample in the laboratory in g/dL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>perfusion index</measure>
    <time_frame>5 hours</time_frame>
    <description>the percentage of perfusion index measured by radical-7 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>plethysmography variability index</measure>
    <time_frame>5 hours</time_frame>
    <description>the percentage of plethysmography variability index measured by radical-7 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>systolic blood pressure</measure>
    <time_frame>5 hours</time_frame>
    <description>systolic blood pressure measured in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diastolic blood pressure</measure>
    <time_frame>5 hours</time_frame>
    <description>diastolic blood pressure measured in mmHg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen saturation from radical-7 device</measure>
    <time_frame>5 hours</time_frame>
    <description>oxygen saturation measured by radical-7 device</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>oxygen saturation from arterial blood gases</measure>
    <time_frame>5 hours</time_frame>
    <description>oxygen saturation measured from arterial blood gases</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <time_frame>5 hours</time_frame>
    <description>number of heart beats per minute</description>
  </secondary_outcome>
  <enrollment type="Actual">56</enrollment>
  <condition>Congenital Heart Disease</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>radical-7 pulse co-oximeter</intervention_name>
    <description>Radical-7 pulse co-oximter will be applied to the patient through a special probe attached the the patient digit to measure blood hemoglobin</description>
    <other_name>Masimo pulse co-oximeter</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study will include children less than 8 years with congenital hear diseases scheduled&#xD;
        for surgery or endo-vascular iintervention&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  infants and children less than 8 years&#xD;
&#xD;
          -  with congenital heart disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refusal of the patient surrogate to share in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahmed Mukhtar, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Head of research committee section in anesthesia department</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 10, 2017</study_first_submitted>
  <study_first_submitted_qc>August 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>September 29, 2019</last_update_submitted>
  <last_update_submitted_qc>September 29, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Hasanin</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</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/NCT03248830
org study id: N-99-2017
nct id: NCT03248830
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The investigators will evaluate the accuracy of non-invasive hemoglobin monitor (Sp-Hb)
      compared to traditional laboratory hemoglobin (Lab-Hb) in children with congenital heart
      disease. The investigators will also compare the accuracy of Sp-Hb in cyanotic children to
      acyanotic children.
Blood hemoglobin is measured daily in clinical practice. Laboratory measurement (Lab-Hb) of
      is the gold standard for assessment of blood hemoglobin. Recently, non-invasive monitors had
      been introduced. Non-invasive measurement of hemoglobin (Sp-Hb) would save time and minimize
      the risk of infection. Blood sampling in children is usually more difficult and stressful;
      moreover, it also carries the risk of iatrogenic anemia.

      Radical-7 (Masimo corporation, Irvine, CA) is a device that operates using the principle of
      co-oximetry . Radical-7 had been validated in various clinical purposes. Measurement of blood
      hemoglobin is an important application for Radical-7 device. Non-invasive hemoglobin (Sp-Hb)
      measurement has been frequently validated in adults; as well as in pediatric patients;
      however, its accuracy in children with congenital heart disease was not investigated.
      Congenital heart disease infants usually undergo major operations and frequently need
      transfusion of blood. Moreover, these patients have special circulatory physiology that might
      impact the device accuracy. It had been recently reported that the performance of co-oximetry
      in congenital heart disease children is poor in measurement of oxygen saturation specially at
      oxygen saturation under 75%; however, its accuracy in measurement of hemoglobin was not
      investigated yet. In this study, the investigators will evaluate the accuracy of Sp-Hb
      compared to traditional Lab-Hb in children with congenital heart disease. the investigators
      will also compare the accuracy of Sp-Hb in cyanotic children to acyanotic children.
observational model: Cohort
time perspective: Prospective
measure: non-invasive hemoglobin
time frame: 5 hours
description: the value of hemoglobin measured by radical-7 device in g/dL
measure: laboratory hemoglobin
time frame: 5 hours
description: the value of hemoglobin measured from a blood sample in the laboratory in g/dL
measure: perfusion index
time frame: 5 hours
description: the percentage of perfusion index measured by radical-7 device
measure: plethysmography variability index
time frame: 5 hours
description: the percentage of plethysmography variability index measured by radical-7 device
measure: systolic blood pressure
time frame: 5 hours
description: systolic blood pressure measured in mmHg
measure: diastolic blood pressure
time frame: 5 hours
description: diastolic blood pressure measured in mmHg
measure: oxygen saturation from radical-7 device
time frame: 5 hours
description: oxygen saturation measured by radical-7 device
measure: oxygen saturation from arterial blood gases
time frame: 5 hours
description: oxygen saturation measured from arterial blood gases
measure: heart rate
time frame: 5 hours
description: number of heart beats per minute
intervention type: Device
intervention name: radical-7 pulse co-oximeter
description: Radical-7 pulse co-oximter will be applied to the patient through a special probe attached the the patient digit to measure blood hemoglobin
other name: Masimo pulse co-oximeter
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 8 Years
healthy volunteers: No
last name: Ahmed Mukhtar, Professor
role: Study Director
affiliation: Head of research committee section in anesthesia department
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Hasanin
investigator title: Assistant professor
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
sharing ipd: No