New Study Published on Masimo SpHb ® Continuous and Noninvasive Hemoglobin Monitoring Solution

New Prospective Study Finds That Masimo SpHb® Noninvasive and Continuous Hemoglobin Monitoring Can Help Provide Effective Blood Management in Patients Undergoing Major Surgery.

Norso Medical partner company – Masimo – today announced the findings of a prospective, double-blinded, randomized, controlled trial published in the Journal of the College of Physicians and Surgeons Pakistan. In the study, Dr. Sukriye Akdag and colleagues at Marmara University in Istanbul, Turkey assessed the impact of noninvasive and continuous hemoglobin monitoring with Masimo SpHb® on blood transfusion management for adult patients undergoing elective major surgery with anticipated blood loss of 20% or more. The researchers found that the postoperative red blood cell (RBC) transfusion rate was lower, and the hemoglobin level of ICU patients higher, when monitored with SpHb in the operating room. They concluded, “SpHb can provide effective patient blood management in cases of major surgery.”1

Noting that delayed or unnecessary blood transfusions have been associated with increased mortality and morbidity, the researchers sought to evaluate the impact of continuous hemoglobin monitoring with Masimo SpHb, which offers continuous trending of hemoglobin levels, provided noninvasively and in real time. The researchers enrolled 120 patients aged 18-85 (ASA score I-III) scheduled for major surgery, divided randomly into an SpHb group (n=60) and a control group (n=60). There were no significant differences in the demographics or mean arterial pressure, heart rate, or arterial blood gas analysis between the groups. In the control group, patients’ hemoglobin was measured using conventional, intermittent blood sampling, analyzed with an ABL800Flex Radiometer, at the beginning, the second hour, the fourth hour, and the end of the operation. In the SpHb group, in addition to conventional blood sampling, patients’ SpHb values, pleth variability index (Masimo PVi®) and perfusion index (Pi) were noninvasively and continuously monitored with Masimo Radical-7® Pulse CO-Oximeters®; in the case of a sudden decrease in hemoglobin value, an additional blood gas analysis was performed. In both groups, transfusion was carried out when hemoglobin levels fell below 9 g/dL (per standard European Society of Anaesthesia recommendations) by blood gas analysis.

The researchers found that, comparing overall postoperative measurements, there were no significant differences between the groups in hemoglobin, platelet, or creatinine levels; nor in the amount of fresh frozen plasma, or platelet suspension transfused intraoperatively and postoperatively; nor in the amount of RBC units transfused intraoperatively. However, the postoperative RBC transfusion rate in the SpHb group was significantly lower (SpHb group: median 0 international units (IUs); control group: median 2 IUs; p=0.020).* Postoperative hemoglobin levels in SpHb group patients in the ICU were also statistically significantly higher (SpHb group: 8.41 g/dL ± 1.08 g/dL; control group: 7.75 g/dL ± 1.19 g/dL; p=0.033).

The investigators concluded, “SpHb measurement in major surgical cases can accompany conventional Hb measurement methods, allowing effective patient blood management practice. … Since this may decrease mortality and morbidity by reducing postoperative blood transfusion, the use of such an advanced monitoring method in major surgeries may increase patient safety.”

This study adds additional evidence to the growing literature on the value of continuous hemoglobin monitoring with SpHb. SpHb, as part of patient blood management programs, has been found to improve outcomes in both high- and low-blood loss surgeries, such as reducing the percentage of patients receiving allogeneic transfusions,2,3 reducing the units of red blood cells transfused per patient,4-6 reducing the time to transfusion,7 reducing costs,8 and even reducing mortality 30 and 90 days after surgery by 33% and 29%, respectively (when combined with a goal-directed fluid therapy algorithm using Masimo PVi).9 This evidence of SpHb’s impact on outcomes spans the globe, now representing 7 countries on 4 different continents.1-9 Today, Masimo SpHb technology supports clinicians and patient care in more than 75 countries.

SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors, patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

Further Details of the Study can be found here

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