New Study Investigates the Performance of Masimo SpHb® During Acute Bleeding and After Fluid Resuscitation

Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers at Cairo University in Egypt evaluated the accuracy and trending of Masimo noninvasive and continuous hemoglobin (SpHb^®), referenced to an invasive laboratory hemoglobin (Lab-Hb) measurement, during acute bleeding and after fluid resuscitation.¹

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Masimo Radical-7® with SpHb®, PVi®, and RD rainbow SET™ Sensor (Photo: Business Wire)

In the study, Dr. Adel and colleagues sought to investigate the performance of SpHb in different volume statuses and perfusion states. They utilized intraoperative data from 70 patients scheduled for major orthopedic procedures with anticipated major blood loss. SpHb, as well as Masimo PVi^® and Pi, were measured using a Masimo Radical-7^® Pulse CO-Oximeter^®. Lab-Hb was measured using a Beckman Coulter LH 750 analyzer. SpHb and Lab-Hb were recorded at three times – a baseline reading five minutes after endotracheal intubation, after major bleeding, and after fluid resuscitation – resulting in 210 time-matched readings, which were divided into fluid responsive and fluid non-responsive samples and low and high perfusion index samples.

Using Bland-Altman analysis, the researchers found “excellent correlation” between Lab-Hb and SpHb (r=0.938). In addition, they reported “excellent accuracy with moderate levels of agreement,” as noted below, for various sample sets:

Sample set

Mean bias

Limits of agreement

All

0.01

-1.33 to 1.34 g/dL

Fluid non-responsive

-0.08

-1.27 to 1.11 g/dL

Fluid responsive

0.09

-1.36 to 1.54 g/dL

High Pi

0.01

-1.34 to 1.31 g/dL

Low Pi

0.04

-1.31 to 1.39 g/dL

The researchers also noted that polar plot analysis (angular bias of -4°) showed “good trending ability for SpHb as a follow-up monitor.”