Masimo (NSDQ:MASI) today released results from a study which compared the company’s noninvasive SpHb measurement to conventional laboratory HbL measurements for patients undergoing liver transplantation, touting equivalence between the 2 methods.
Researchers in the study reported that Masimo’s SpHb monitoring had “clinically acceptable accuracy of hemoglobin measurement [compared] with a standard laboratory device when used during LT,” according to the company.
Masimo said that monitoring a patient’s hemoglobin is essential during liver transplants because shifts in blood and fluid can cause graft dysfunction due to hypo-perfusion and tissue hypoxia, and that over-transfusion can cause end organ damage and graft dysfunction.
“In prior studies using SpHb monitoring, reductions in blood transfusion were observed and when used with PVi, another Masimo noninvasive measurement, a reduction in 30-day mortality was observed. Dr. Kayhan’s study adds to the evidence that SpHb may be a useful tool during procedures such as liver transplantation,” founder & CEO Joe Kiani said in a press release.
Reserachers investigated results from 55 patients undergoing orthotopic liver transplants, with Hb levels analyzed using a Beckman Coulter LH 780 hematology analyzer and Masimo’s Radical-7 Pulse CO-Oximeter and rainbow ReSposable R2-25r and R2-25a sensors.
Arterial blood samples were taken 6 times, with 2 draws during each of the 3 phases of surgery. SpHb values were recorded within 10 seconds of each blood sample, the company said, with a total of 282 paired measurements collected.
Researchers in the study determined that the correlation between the sets of paired measurements were “highly significant.”
“Results of this study show that SpHb has clinically acceptable accuracy of Hb measurement as compared with a standard laboratory device when used during LT. This technology may provide more timely information on Hb status than intermittent blood sample analysis and thus has the potential to improve blood management during LT. The trending accuracy may not only detect occult bleeding but can also prevent overtransfusion after bleeding; at least this method has the potential to supplement detection of changes. Nevertheless, due to underestimation in the lower Hb values, clinicians should be cautious when making decisions based on SpHb alone. Instead of focusing on a single value, SpHb may be considered an early warning system and a trend monitor. Future studies should evaluate the utility of SpHb in terms of overall clinical outcomes of transfusion decision,” researchers concluded, according to Masimo.