Non-invasive Hemoglobin Monitoring in Congenital Heart Diseased Children

Completed

• Conditions: Congenital Heart Disease

• Registration Number: NCT03248830
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-10
• Study First Submitted QC: 2017-08-10
• Study First Posted: 2017-08-14
• Study Start: 2018-02-20
• Primary Completion: 2019-08-01
• Status Verified: 2019-09
• Study Completion: 2019-09-10
• Last Update Submitted: 2019-09-29
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

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

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Exclusion Criteria

• refusal of the patient surrogate to share in the study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
non-invasive hemoglobin	5 hours	the value of hemoglobin measured by radical-7 device in g/dL

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Egypt