New Clinical Studies Presented at the American Society of Anesthesiologists Annual Meeting Show Benefits of Masimo Corporation Noninvasive Technologies: SpHb, PVI, RRa, and SEDLine
Published: Oct 19, 2011
IRVINE, Calif., Oct. 19, 2011 /PRNewswire/ -- Masimo (NASDAQ: MASI) announced today that over 25 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 Chicago, Illinois. The following studies highlight the positive clinical outcomes and patient safety impact of Masimo's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®), pleth variability index (PVI®), acoustic respiration rate (RRa), and SEDLine® brain function monitoring.
SpHb® & PVI®
Researchers Steven Frank, M.D., James Rothschild, M.D., and John Ulatowski, M.D., at Johns Hopkins Hospital in Maryland found that the combination of continuous SpHb and PVI monitoring "may improve the efficacy and safety of the intraoperative autologous normovolemic hemodilution (IAHD) blood conservation technique that helps avoid allogeneic blood transfusions." The study, conducted in patients undergoing major abdominal or orthopedic surgery, concluded that SpHb was advantageous in "eliminating the delay in intraoperative decision-making that occurs when Hb measurements are obtained by conventional laboratory testing" while PVI was a "useful index of intravascular volume during the significant fluid shifts that occurred with IAHD, with increasing PVI indicating hypovolemia and decreasing PVI indicating adequate fluid resuscitation and blood re-infusion." (1)
Two studies, conducted by the Long Beach Veterans Healthcare System in California, found that noninvasive SpHb measurements provided valuable clinical assessment information in remote, rural, and community settings. Nitin Shah, M.D., and Kinjal Shah, B.S., led a study using the Radical-7 in rural India, which concluded that SpHb measurements provided "reliable information compared to the invasive method" with a bias and precision of 0.2+/- 1.2 g/dL and was "very convenient to use in a rural camp setting" while also eliminating "biohazard risks of venipuncture and blood handling."(2) The second study, led by Nitian Shah with Deval Modi, M.B, B.S., performed at two community health fairs in Long Beach concluded that the Pronto-7 spot-check device, with a bias and standard deviation of -0.06 +/-1.07 g/dL, provides "similar values and offers acceptable accuracy" when compared to values obtained from laboratory analysis of invasive blood samples. Researchers also noted the advantages of Pronto-7 in that it "gives immediate result" and has the potential to be "very helpful in spot checking for anemia in the general community without the need for exhaustive set-up or processing time."(3)
Two separate studies showed that the new In Vivo Adjustment feature for noninvasive SpHb measurements, included as part of the new 2011 Radical-7, along with the newest generation rainbow ReSposable Sensors (Rev. E) helped clinicians to improve the agreement in subsequent comparisons between invasive (tHb) and noninvasive (SpHb) hemoglobin measurements. Researchers Kathleen Richard, M.D., Timothy Quill, M.D., Thomas Dodds, M.D., and Matthew Koff, M.D., M.S., at Dartmouth Hitchcock Medical Center in New Hampshire found that the "accuracy and descriptive statistics improved when each time-matched SpHb value was adjusted by the magnitude of difference between the first tHb and corresponding SpHb." Researchers concluded that "if this type of adjustment were performed in real-time in vivo (intra-operatively), overall accuracy of SpHb values may be further improved," which may also "add value to care" during high risk surgical procedures in patients with co-morbidities and "in many other clinical locations and scenarios (ICU, PACU, pediatrics, emergency medicine, surgical ward)."(4) Another study, conducted by Ryo Miyashita, M.D., Shigekazu Sugino, M.D., Yukitoshi Niiyama, M.D., Mitsuko Mimura, M.D., Ph.D., and Michiakii Yamakage, M.D., Ph.D., in Japan at the Sapporo Medical University School of Medicine, found that "SpHb values corrected using the novel program were more accurate than those obtained conventionally." Study results showed that In Vivo Adjustment improved bias and standard deviation from 1.1 +/- 1.0 to 0.0 +/- 0.61 g/dL) and concluded that In Vivo Adjustment should "contribute to the accurate measurement of SpHb in the clinical setting."(5)
Researchers Peter Winch, M.D., Aymen Naguib, M.D., Julie Rice, R.N., and Joseph Tobias, M.D., at Nationwide Children's Hospital showed that SpHb measurements obtained in pediatric patients undergoing acute blood loss correlated to hemoglobin values obtained from a point-of-care device. Researchers evaluated the use of SpHb in a pediatric population undergoing phlebotomy and concluded that SpHb provided "accurate and continual real-time data which can inform medical care".(6)
In a separate study, also conducted at Nationwide Children's Hospital, the same research team found that monitoring changes in PVI could be used as a guide for volume replacement during isovolemic hemodilution in pediatric patients undergoing congenital cardiac surgery. Patients were evaluated in two groupsgroup 1 had starting PVI values less than 14 and group 2 had starting PVI values greater than 14. Results showed that the average crystalloid replacement in group 1 was 5ml/kg, while volume replacement in group 2 was 11ml/kg in order to maintain the same hemodynamics during hemodilution. Researchers noted that the "data demonstrates the possible advantage of using the PVI value as a tool for identifying patients who would be good candidates for isovolemic hemodilution."(7)
Rainbow Acoustic Monitoring for RRa
Researchers Basavana Goudra, M.D., and Lakshmi Penugonda, M.D., at the Hospital of the University of Pennsylvania, evaluated RRa measurements obtained using the Masimo Rad-87 during upper gastrointestinal endoscopy and found it had the "best accuracy and precision (-0.3 +/- 1.0 bpm) of monitoring respiration rate," whereas EtCO2 (-0.6 +/- 6.1 bpm) and impedance pneumography (0.2 +/- 4.3 bpm) are "subject to frequent false alarms." Results showed that EtCO2 had the "highest incidence of false alarms" with 45 false alarms out of 52 events, while RRa had the "lowest rate of false alarms" with just 3 out of 52 events.(8)
In a study conducted at Loma Linda University Medical Center, researchers Kevin Nasseri-Noori, M.D., Deborah McIvor, M.D., Frank Hsu, M.D., Moses Olson, B.S., Martin Allard, M.D., Travis Losey, M.D., Mark Macknet, M.D., and Richard Applegate, M.D., demonstrated that the SEDLine 4-channel (PSA array) brain function monitor "correctly detected an excessively deep intraoperative burst suppression therapy (IBST) pattern given a nearly isoelectric EEG" in 16 out of 19 events during intracranial surgery. With an overall correlation of 93% between SEDLine (PSA array) and EEGshowing strong agreementstudy results indicate that SEDLine may be an effective tool for IBST detection versus standard EEG, which is expensive and requires a special technician in the room.(9)
According to Nitin Shah, MD, Chief of Surgical ICU at Long Beach VA Hospital and Professor of Anesthesiology at Loma Linda University, "Noninvasive SpHb is the way of the future. It is truly a blessing for a developing country with limited resources. Patients appreciate that it eliminates the need for traditional needle stick blood draws, so they are much more relaxed and willing to complete the pain-free SpHb testing. And, for healthcare professionals it is unbelievable. There are no biohazard risks, no formal training required to operate, and no calibration required with SpHb testing and they get instant results that they can use immediately to advise their patients right on the spot. In my view, SpHb should be routinely used in clinics and community settings across the globe."
Basavana Goudra, MD, Assistant Professor of Anesthesiology and Critical Care at the Hospital of the University of Pennsylvania, commented, "Masimo rainbow acoustic monitoring is better than anything else we have at the moment for accurate and reliable respiration rate measurements. Not only was it easy to use in the majority of the patients enrolled in our study, but our results show that it is the perfect solution for routine use in upper GI endoscopy procedures and post-operative monitoring as EtCO2 is not useful in these situations.
(1) Frank S, Rothschild J, Ulatowski J. "Continuous Noninvasive Hemoglobin Monitoring for Jehovah's Witness Patients Undergoing Intraoperative Autologous Normovolemic Hemodilution" ASA 2011 Presentation A408.
(2) Shah N, Shah K. "Evaluation of a Pulse CO-Oximeter for Noninvasive Hemoglobin Measurement in Adult Population in Rural India" ASA 2011 Presentation A283.
(3) Shah N, Modi D. "Accuracy of Noninvasive Hemoglobin Measurement Through a Pulse CO-Oximeter Compared to Venous Blood Draw in a Community Setting" ASA 2011 Presentation A285.
(4) Richard K, Quill T, Dodds T, Koff M. "Improved Accuracy and Trending of Noninvasive Hemoglobin Measurements with 'In Vivo Adjustment'" ASA 2011 Presentation A1667.
(5) Miyashita R, Sugino S, Niiyama Y, Mimura M, Yamakage M. "Improved Noninvasive Total Hemoglobin Measurements After In Vivo Adjustment" ASA 2011 Presentation A410.
(6)Winch P, Naguib A, Rice J, Tobias J. "The Accuracy of Noninvasive Hemoglobin Monitoring Following Phlebotomy in a Pediatric Patient Population" ASA 2011 Presentation A411.
(7) Naguib A, Winch P, Rice J, Tobias J. "Can the Starting Pulse Oximeter Derived Pleth Variability Index (PVI) Predict Total Crystalloid Replacement During Isovolemic Hemodilution in Congenital Cardiac Surgery?" ASA 2011 Presentation A207.
(8) Goudra B., Penugonda L. "Monitoring Respiration in Upper GI Endoscopy Anesthesia" ASA 2011 Presentation A246.
(9) Nasseri-Noori K, McIvor D, Hsu F, Olson M, Allard M, Losey T, Macknet M, Applegate R. "Prospective Comparison of Global Electroencephalogram to Frontal SEDLine Electroencephalogram Monitoring for the Evaluation of Intraoperative Burst Suppression During Elective Intracranial Surgery" ASA 2011 Presentation A499.
*In-Vivo Adjustment is pending FDA 510(k) clearance.
**To see a summary of all known clinical studies and abstracts on Masimo technologies and noninvasive measurements, please visit: http://www.masimo.com/cpub/clinicals.htm.
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient carehelping solve "unsolvable" problems. In 1995, the company debuted Measure-Through Motion and Low Perfusion pulse oximetry, known as Masimo SET®, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow SET® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures, including total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). In 2008, Masimo introduced Patient SafetyNet, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow Acoustic Monitoring, the first-ever noninvasive and continuous monitoring of acoustic respiration rate (RRa). Masimo's rainbow SET technology platform offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options. In 2010, Masimo acquired SEDLine®, a pioneer in the development of innovative brain function monitoring technology and devices. Masimo SET and Masimo rainbow SET technologies can be also found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world. Founded in 1989, Masimo has the mission of "Improving Patient Outcome and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications®." Additional information about Masimo and its products may be found at www.masimo.com.
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including: total hemoglobin (SpHb®), PVI®, acoustic respiration rate (RRa), and SEDLine® contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including: immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
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