Non-invasive Hemoglobin Monitoring in Congenital Heart Diseased Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Non-invasive Hemoglobin Monitoring in Children With Congenital Heart Diseases

Conditions
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Congenital Heart Disease

Intervention / Treatment
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* Device: radical-7 pulse co-oximeter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| non-invasive hemoglobin | the value of hemoglobin measured by radical-7 device in g/dL | 5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| laboratory hemoglobin | the value of hemoglobin measured from a blood sample in the laboratory in g/dL | 5 hours | 
| perfusion index | the percentage of perfusion index measured by radical-7 device | 5 hours | 
| plethysmography variability index | the percentage of plethysmography variability index measured by radical-7 device | 5 hours | 
| systolic blood pressure | systolic blood pressure measured in mmHg | 5 hours | 
| diastolic blood pressure | diastolic blood pressure measured in mmHg | 5 hours | 
| oxygen saturation from radical-7 device | oxygen saturation measured by radical-7 device | 5 hours | 
| oxygen saturation from arterial blood gases | oxygen saturation measured from arterial blood gases | 5 hours | 
| heart rate | number of heart beats per minute | 5 hours |