Study Demonstrates Reduction in Mortality Using Masimo Noninvasive, Continuous Hemoglobin (SpHb) and Pleth Variability Index (PVi) Monitoring
Masimo (NASDAQ: MASI) announced today that in a study published in the Journal of Clinical Monitoring and Computing, researchers investigated the effects of implementing a hospital-wide fluid and blood administration protocol using two Masimo measurements: noninvasive, continuous hemoglobin (SpHb) and pleth variability index (PVi).1 To evaluate the impact of the implementation, they collected data on transfusions and mortality 30 and 90 days after surgery and compared the findings between two 11-month periods in 2013 and 2014.
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Masimo Root with SpHb and PVi (Photo: Business Wire)
In the study, Dr. Jérôme Cros, Prof. Nathalie Nathan, and colleagues at Hôpital Dupuytren, part of the Centre Hospitalier Universitaire of Limoges, France (CHU Limoges), sought to determine if the use of a goal-directed therapy (GDT) algorithm based on monitoring with SpHb and PVi could decrease blood requirements and reduce mortality in common clinical practice. The researchers divided 18,716 patients into 3 groups: G1 (9285 patients who underwent surgery in 2013, before implementation of the goal-directed therapy algorithm), G2 (5856 patients who underwent surgery in 2014 without use of the algorithm), and G3 (3575 patients who underwent surgery in 2014 with use of the algorithm).
For the 2014 patients, Masimo Radical-7 Pulse CO-Oximeters equipped with SpHb and PVi were installed in all operating rooms, recovery rooms, and intensive care units. The entire anesthesiology team, including nurses, was trained on use of the monitors and the algorithm, and was free to decide whether or not to use goal-directed therapy for each case. Transfusion and mortality data were recorded for all patients.
Using multivariate analysis and including age, ASA class, surgical severity and emergency as co-variables, the risk of death for G3 patients was 33% lower at 30 days and 29% lower at 90 days, compared to G1 patients. By contrast, there was no difference in the risk of death between G2 and G1 patients.
The authors also reported on mortality rate the year after the study ended (2015), when the hospital no longer had access to SpHb and PVi. Comparing 2015 patients to patients in the study, they found that mortality at 30 and 90 days increased again to levels similar to those found in 2013 (before implementation), respectively 2.18% and 3.09%.