An observational study in Congenital Heart Disease, sponsored by Cairo University. Completed at 1 site in Egypt. Open to participants aged 1 Month to 8 Years. Per ClinicalTrials.gov, last updated 2019-10-01.
Sponsored by Cairo University · Observational
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.
3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.
This study's enrollment of 56 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.
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The study will include children less than 8 years with congenital hear diseases scheduled for surgery or endo-vascular iintervention
Exclusion Criteria:
Radical-7 pulse co-oximter will be applied to the patient through a special probe attached the the patient digit to measure blood hemoglobin
Also known as: Masimo pulse co-oximeter
non-invasive hemoglobin
the value of hemoglobin measured by radical-7 device in g/dL
Time frame: 5 hours
laboratory hemoglobin
the value of hemoglobin measured from a blood sample in the laboratory in g/dL
Time frame: 5 hours
perfusion index
the percentage of perfusion index measured by radical-7 device
Time frame: 5 hours
plethysmography variability index
the percentage of plethysmography variability index measured by radical-7 device
Time frame: 5 hours
systolic blood pressure
systolic blood pressure measured in mmHg
Time frame: 5 hours
diastolic blood pressure
diastolic blood pressure measured in mmHg
Time frame: 5 hours
oxygen saturation from radical-7 device
oxygen saturation measured by radical-7 device
Time frame: 5 hours
oxygen saturation from arterial blood gases
oxygen saturation measured from arterial blood gases
Time frame: 5 hours
heart rate
number of heart beats per minute
Time frame: 5 hours
Plan to share: No
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This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Cairo University