Validation of Non-invasive Hemoglobin (SpHb) Measurement in Children

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the value of the new technique of non-invasive measurement of Hb in children undergoing a surgical procedure.

Detailed Description
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Several surgical procedures require haemoglobin monitoring due to possible blood loss and the need of blood transfusion. The standard for monitoring hemoglobin (Hb) is the measurement of blood samples. The novel technique of non-invasive continuous measurement of Hb using Pulse CO-Oximetry may allow measuring Hb without obtaining blood samples. This new technique has not been tested yet in children undergoing anesthesia for elective surgical procedures. In this study the investigators compare the non-invasive Hb measurement with Masimo® technology (SpHb) with the standard Hb measurement using ABL-800 Flex (BGA) and Siemens Advia (labHb, reference method) before the children undergo the surgical procedure.

Official Title
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Validation of Non-invasive Hb-measurement (SpHb) in Children With the Masimo@ Radical 7

Conditions
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Non-invasive Hb Measurement in Children

Intervention / Treatment
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* Device: non-invasive measurement of Hb
* Procedure: taking blood samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children (>= 3 kg until 8 years) ASA I-III written informed consent of legal representative Exclusion Criteria: children <= 3kg or > 8 years emergency surgery allergy against sensor of SpHb(®) artery occlusive disease sepsis haemoglobinopathy specific medical or psychological circumstances which do not allow the consent of the legal representative or the performance of the study

Ages Eligible for Study
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Maximum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: inhalation group<br>20 children Taking blood samples and SpHb-measurement was made under inhalational anesthesia | Device: non-invasive measurement of Hb<br> <br> * Other names: SpHb (®) by Masimo ® Radical 7;Procedure: taking blood samples<br> <br> * Other names: blood for laboratory Hb (Siemens Advia);|
| Other: non-inhalational<br>40 children Taking blood samples and SpHb measurements in awake and spontaneous breathing children. | Device: non-invasive measurement of Hb<br> <br> * Other names: SpHb (®) by Masimo ® Radical 7;Procedure: taking blood samples<br> <br> * Other names: blood for laboratory Hb (Siemens Advia);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between SpHb(®) and the Hb measured by the ABL800Flex and the Siemens Advia |  | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| influence of inhalation anesthetics | The blood samples are taken from the needle infusion set the child gets for anesthesia. Some children will need an inhalational induction of anesthesia before they can get the needle and the sensor for the SpHb (®) monitoring. So an influence of the application of inhalation anesthetics on the accuracy of the SpHb (®) will be tested. | one day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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non-invasive Hb measurement in children