Randomized Controlled Trial Finds Masimo PVI Improves Fluid Management During Surgery

IRVINE, Calif., Aug. 31 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI) announced today that a new randomized controlled trial published in Anesthesia & Analgesia shows that clinicians using Masimo Pleth Variability Index (PVI®) significantly improved fluid management and reduced lactate levels in patients during and after surgery, compared to patients managed by standard care without PVI(1).  Multiple previous studies(2,3,4) have shown that PVI predicts fluid responsiveness, defined as a significant increase in cardiac output after fluid administration, but this is the first published study to show that the use of PVI can improve patient management compared to a group of patients not managed with PVI.  

Although fluid administration is critical to optimizing patient status and enabling end organ preservation, unnecessary fluid administration is associated with increased morbidity and mortality.  Traditional invasive measurements such as central venous pressure (CVP) are not reliable in predicting whether a patient will benefit from fluid administration, and newer methods of predicting fluid responsiveness are invasive and/or costly. Masimo PVI provides clinicians with a noninvasive, continuous, and cost-effective measure in assessing whether patients will benefit from fluid administration to enable more personalized and targeted fluid therapy.

In the current study, researchers from the University Catholique de Louvain, St. Luc Hospital in Brussels, Belgium, randomized 82 patients undergoing abdominal surgery into two groups, a control group where fluid management was guided by standard care through CVP and clinician assessment, and the PVI group where fluid management was guided by standard care and PVI values from a Masimo Radical-7® Pulse CO-Oximeter®.  In the PVI group, 500mL of crystalloids were infused at induction, followed by 2mL per kg per hour continuous infusion. A 250mL bolus of colloid was added if the PVI exceeded 13% for more than 5 minutes. In the control group, 500mL of crystalloids were infused at induction, followed by continuous infusion of crystalloids (4 to 8mL per kg per hour) and a 250mL bolus of colloids was given to compensate acute blood losses (>50mL), maintain mean arterial pressure above 65mmHg and the central venous pressure above 6mmHg.  

The results showed that the PVI group received significantly lower amounts of intraoperative crystalloids (P=0.004) and total volume infused (P=0.049), and lactate levels were significantly lower during surgery (1.2 mmol/L +/- 0.6 vs 1.6 +/- 1.2, P=0.04), 24-hours post-operatively (1.4 +/- 0.3 vs 1.8 +/- 1.0, P=0.02), and 48-hour post-operatively (1.2 +/- 0.3 vs 1.4 +/- 0.4, P=0.03).  The researchers concluded that "PVI-based goal directed fluid management reduced the volume of intraoperative fluid infused and reduced both intraoperative and postoperative lactate levels."  Study authors also noted that the reduction in lactate levels for PVI-guided patients suggests that "PVI-guided fluid management may lead to fluid administration that is tailored to each individual patient's needs."

PVI is available as part of Masimo rainbow® SET platform—the first-and-only technology to noninvasively and continuously measure total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVI®), perfusion index (PI), and acoustic respiration rate (RRa™), in addition to the 'gold standard' Measure-Through Motion and Low Perfusion performance of Masimo SET® oxyhemoglobin (SpO2), and pulse rate (PR).

"The clinical merit of using a dynamic index like PVI to guide fluid administration relates to a timing issue," stated William E. Johnston, MD, Professor and Associate Chair, Vice Chair of Academic Affairs in the Department of Anesthesiology at Scott & White Memorial Hospital in Temple, Texas.  "What's so unique about PVI is that it allows the medical team to rapidly fine tune fluid administration using a Masimo Radical-7 Pulse CO-Oximeter in the operating room before global hypovolemia and hypoperfusion occur.  Consequently, an appropriate amount of fluid can be administered at the most opportune time."

About Masimo

Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive monitoring technologies that significantly improve patient care—helping 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.

Forward Looking Statements

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 PVI will help to improve perioperative fluid management for all surgical patients, and risks related to our assumptions that Masimo PVI-guided fluid management during surgery will help to reduce hypotension and improve circulatory status and renal function in all surgical patients,  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 forward-looking 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.\

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI, rainbow Acoustic Monitoring, RRa, Radical-7, Rad-87, Rad-57,Rad-8, Rad-5,Pulse CO-Oximetry, Pulse CO-Oximeter, and SEDLine  are trademarks or registered trademarks of Masimo Corporation.

(1) Forget, Patrice; Lois, Fernande; De Kock, Marc.  "Goal-Directed Fluid Management Based on the Pulse Oximeter-Derived Pleth Variability Index Reduces Lactate Levels and Improves Fluid Management."  Anesthesia  & Analgesia. August 2010. Published online ahead of print here.  

(2) Cannesson M, Desebbe O, Rosamel P, Delannoy B, Robin J, Bastien O, Lehot JJ. "Pleth variability Index to Monitor the Respiratory Variations in the Pulse Oximeter Plethysmographic Waveform Amplitude and Predict Fluid Responsiveness in the Operating Theatre." British Journal of Anaesthesia August 2008; 101(2):200-6.  Available online here.

(3) Markus Zimmerman, Thomas Feibicke, Cornelius Keyl, Christopher Prasser, Stefan Moritz, Bernhard M. Graf, and Christoph Wiesenack. "Accuracy of Stroke Volume Variation Compared with Pleth Variability Index to Predict Fluid Responsiveness in Mechanically-ventilated Patients Undergoing Major Surgery."  European Journal of Anaesthesiology June 2010; 27(6):555-61. Available online here.

(4) M. Feissel, R. Kalakhy, J. Badie, G. Robles, J. Faller, JL. Teboul. "Plethysmography Variability Index: A New Fluid Responsiveness Parameter." Presented at the 29th International Symposium on Intensive Care and Emergency Medicine (ISICEM) Annual Meeting, March 25, 2009, Brussels, Belgium.  Available online here.

SOURCE Masimo Corporation