
Multiple New Clinical Studies Presented at the American Society of Anesthesiologists Annual Meeting Show Benefits of Masimo Noninvasive Patient Monitoring Technologies: SpHb, PVI, RRa, and SEDLine
Irvine, California – October 18, 2012 – Masimo (NASDAQ: MASI) announced today that eight significant new clinical studies evaluating Masimo noninvasive patient monitoring technologies were presented at the largest gathering of anesthesiologists in the world, the American Society of Anesthesiologists (ASA) Annual Meeting in Washington, D.C. The following studies highlight the positive clinical outcomes and patient safety impact of Masimo's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®), PVI®, acoustic respiration rate (RRa™), and SEDLine® brain function monitoring.
Noninvasive Total Hemoglobin (SpHb®)
At Fujisawa Municipal Hospital, in Fujisawa, Japan, researchers found that "continuous monitoring of SpHb by pulse oximetry enabled us to evaluate relative change in blood volume and adjust ultrafiltration rate to plasma refilling rate," and concluded: "The results of this study indicate that SpHb monitoring contributes to effective ultrafiltration and stable blood purification."1
At the Seoul National University Hospital, in Seoul, Korea, researchers found that the change in bias and precision of SpHb when compared to invasive laboratory hemoglobin was not significantly different before vs. after intravenous volume loading in children during neurosurgery. The study concluded: "The Radical-7 Pulse CO-Oximeter® can be useful as a trend monitor in children during operation even immediately after volume expanders are administered."2
In another study, researchers Nitin Shah, M.D., and Deval Modi, M.B.,B.S., at the VA Long Beach Healthcare System in Long Beach, Calif., conducted noninvasive hemoglobin testing in patients undergoing cataract surgery in South Africa and with health fair participants in Southern California and showed that Masimo's Pronto-7® noninvasive spot-check hemoglobin device performs "with acceptable reliability" in populations with darker skin pigmentation and "was able to obtain SpHb readings in the vast majority of subjects of both light and dark skin pigmentation."3
Pleth Variability Index (PVI®)
A study at the University of Bordeaux, in Bordeaux, France, by researchers Thakoor Bhismadev, M.D., Tarik Riahi, M.D., Olivier Bernard, M.D., Musa Sesay, M.D., Pierre Maurette, M.D., and Karine Nouette-Gaulain, M.D., , found that "PVI can reliably predict fluid responsiveness in neurosurgical patients in the ICU."4
rainbow® Acoustic Monitoring™ for RRa™
In a multi-center study at Cincinnati Children's Hospital Medical Center, University of Arizona Medical Center, and Children's Medical Center at Dallas, by researchers Mario Patino, M.D., Mohamed Mahmoud, M.D., Dean Kurth, M.D., Daniel Redford, M.D., Thomas Quigley, M.D., and Peter Szmuk, M.D., found that RRa "showed a bias, precision and accuracy root mean square (Arms) of -0.02, 3.25 and 3.25 breaths per minute (bpm) compared to the reference method, whereas capnography showed a bias, precision and Arms of 0.23, 3.29 and 3.30 bpm." They concluded: "This multicenter study showed that respiratory rate measured from noninvasive, acoustic monitoring had similar accuracy and precision as nasal capnography, the current standard of care when used in pediatric patients."5
A study at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia, by Jeff Mandel, M.D., M.S., and Joshua Atkins, M.D.,Ph.D., found that RRa compared favorably to capnography and respiratory inductance plethysmography (RIP), concluding that RRa "displayed good accuracy and precision compared to capnography, demonstrating a good alternative for patients not tolerating capnography." Researchers noted that RRa comparison to RIP produced a larger bias and precision, possibly due to noise of RIP recordings during patient transport from OR to PACU, showing RRa utility under such interfering conditions for RIP."6
A separate study at Stanford University School of Medicine, by Pedro Tanaka, M.D., David Drover, M.D., and Maria Tanaka, M.D., evaluated the accuracy of respiration rate monitored by CapnoStream (RRetCO2) and RRa in anesthetized patients under sedation and concluded: "The use of RRa could be a good alternative for the perioperative period as most patients will have received sedation during surgery and need to be monitored in PACU and later on the patient wards."7
SEDLine®
Results from a study conducted at the University of California San Francisco by researchers Susana Vacas, M.D., Erin McInrue, M.P.H., Mervyn Maze, M.D., and Jacqueline Leung, M.D.,Ph.D., using the SEDLine 4-channel brain function monitor "confirmed the utility of a portable monitor to measure different sleep stages." Researchers concluded: "Having the ability to continuously monitor sleep in the ICU setting will facilitate clinical trials with goal-directed interventions that rectify sleep disruption. Targeting modifiable risk factors such as sleep disruption may ultimately decrease delirium and associated adverse events in the critically ill patients."8
Media Contact:
Mike Drummond
Masimo Corporation
Phone: (949) 297-7434
Email: mdrummond@masimo.com
