Non-invasive Hemoglobin Monitoring in Congenital Heart Diseased Children

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03248830
• Other study ID #: N-99-2017
• Status: Completed
• Start date: February 20, 2018
• Est. completion date: September 10, 2019

Study information

• Verified date: September 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: September 10, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

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

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	non-invasive hemoglobin	the value of hemoglobin measured by radical-7 device in g/dL	5 hours
Secondary	laboratory hemoglobin	the value of hemoglobin measured from a blood sample in the laboratory in g/dL	5 hours
Secondary	perfusion index	the percentage of perfusion index measured by radical-7 device	5 hours
Secondary	plethysmography variability index	the percentage of plethysmography variability index measured by radical-7 device	5 hours
Secondary	systolic blood pressure	systolic blood pressure measured in mmHg	5 hours
Secondary	diastolic blood pressure	diastolic blood pressure measured in mmHg	5 hours
Secondary	oxygen saturation from radical-7 device	oxygen saturation measured by radical-7 device	5 hours
Secondary	oxygen saturation from arterial blood gases	oxygen saturation measured from arterial blood gases	5 hours
Secondary	heart rate	number of heart beats per minute	5 hours