Non-invasive Hemoglobin Monitoring in Congenital Heart Diseased Children

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

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.

Study Overview

• Status: Completed
• Conditions: Congenital Heart Disease
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Actual): August 1, 2019
• Study Completion (Actual): September 10, 2019

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 10, 2017
• First Posted (Actual): August 14, 2017

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 29, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital
• Other Study ID Numbers: N-99-2017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No