Evaluation of the Accuracy and Precision of the Masimo Labs Pulse-Hemoglobin-Meter Monitor in Surgical Patients

Study Overview
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Brief Summary
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The Masimo monitor can measure hemoglobin level noninvasively and accuratly

Detailed Description
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Blood hemoglobin concentration is a very common and essential test to assess patient well being and the need for blood transfusion. In the perioperative period this measurement is further more critical mainly due to the acute nature of blood loss and the need for an immediate response. Currently, hemoglobin concentration is determined by analyzing a blood sample. It requires venipuncture or arterial puncture (via an arterial line). Besides the patient discomfort there are additional disadvantages such as infection, dealing with blood product, delay with diagnosis, low update rate and cost. Masimo Labs is in the process of developing a noninvasive monitor to detect hemoglobin concentrations in real time. The monitor uses a probe placed on the patient finger that gives hemoglobin concentration continuously and noninvasively. Masimo Labs is using a technology that resembles the well accepted and clinically proven pulse-oxymeter. The study will include surgical patients at the UCI Medical Center, preferably in cases that are known to involve major blood loss. For these cases, the anesthesia team places an arterial line for anesthesia purposes. The arterial line is used for continuous blood pressure measurements and blood draw for the assessment of several indices. We plan to compare the hemoglobin concentrations measured from blood samples to the Masimo Labs pulse-hemoglobin level readings.

Official Title
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Evaluation of the Accuracy and Precision of the Masimo Labs Pulse-Hemoglobin-Meter Monitor in Surgical Patients

Conditions
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Adult Patient Undergoing Major Surgery

Intervention / Treatment
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* Device: Masimo hemoglobin-meter
* Biological: drawing blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult having surgery with arterial line Exclusion Criteria: Upper extremities surgery Pregnant women Children

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult patient undergoing a surgery<br>Adult patient undergoing a surgery in the supine position and require an arterial line for anesthesia/surgery purposes | Device: Masimo hemoglobin-meter<br>* Placing a probe on the finger<br>Biological: drawing blood sample<br>* drawing a blood sample less that 0.5 mL each time, for around 10-12 times along the surgery (depends on surgical time)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corrlation of up to +/-0.1 gr% of the blood analysis to the monitor reading |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major surgery, excpected blood loss, arterial line