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Non-invasive Hemoglobin Monitoring in Congenital Heart Diseased Children

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ClinicalTrials.gov Identifier: NCT03248830
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Ahmed Hasanin, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment
Congenital Heart Disease Device: radical-7 pulse co-oximeter

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Non-invasive Hemoglobin Monitoring in Children With Congenital Heart Diseases
Actual Study Start Date : February 20, 2018
Actual Primary Completion Date : August 1, 2019
Actual Study Completion Date : September 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Diseases


Intervention Details:
  • Device: radical-7 pulse co-oximeter
    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


Primary Outcome Measures :
  1. non-invasive hemoglobin [ Time Frame: 5 hours ]
    the value of hemoglobin measured by radical-7 device in g/dL


Secondary Outcome Measures :
  1. laboratory hemoglobin [ Time Frame: 5 hours ]
    the value of hemoglobin measured from a blood sample in the laboratory in g/dL

  2. perfusion index [ Time Frame: 5 hours ]
    the percentage of perfusion index measured by radical-7 device

  3. plethysmography variability index [ Time Frame: 5 hours ]
    the percentage of plethysmography variability index measured by radical-7 device

  4. systolic blood pressure [ Time Frame: 5 hours ]
    systolic blood pressure measured in mmHg

  5. diastolic blood pressure [ Time Frame: 5 hours ]
    diastolic blood pressure measured in mmHg

  6. oxygen saturation from radical-7 device [ Time Frame: 5 hours ]
    oxygen saturation measured by radical-7 device

  7. oxygen saturation from arterial blood gases [ Time Frame: 5 hours ]
    oxygen saturation measured from arterial blood gases

  8. heart rate [ Time Frame: 5 hours ]
    number of heart beats per minute



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Ages Eligible for Study:   1 Month to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study will include children less than 8 years with congenital hear diseases scheduled for surgery or endo-vascular iintervention
Criteria

Inclusion Criteria:

  • infants and children less than 8 years
  • with congenital heart disease

Exclusion Criteria:

  • refusal of the patient surrogate to share in the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248830


Locations
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Egypt
Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: Ahmed Mukhtar, Professor Head of research committee section in anesthesia department

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Responsible Party: Ahmed Hasanin, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT03248830     History of Changes
Other Study ID Numbers: N-99-2017
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Heart Defects, Congenital
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities