Clinical trial NCT03248830: Non-invasive Hemoglobin Monitoring in Congenital Heart Diseased Children
Official title: Evaluation of Non-invasive Hemoglobin Monitoring in Children With Congenital Heart Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-08-14
Enrollment: 56
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: non-invasive hemoglobin
timeFrame: 5 hours
Secondary outcomes:
measure: laboratory hemoglobin
timeFrame: 5 hours
measure: perfusion index
timeFrame: 5 hours
measure: plethysmography variability index
timeFrame: 5 hours
measure: systolic blood pressure
timeFrame: 5 hours
measure: diastolic blood pressure
timeFrame: 5 hours
measure: oxygen saturation from radical-7 device
timeFrame: 5 hours
measure: oxygen saturation from arterial blood gases
timeFrame: 5 hours
measure: heart rate
timeFrame: 5 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
affiliation: Head of research committee section in anesthesia department
name: Ahmed Mukhtar, Professor
role: STUDY_DIRECTOR
References: