July 16, 2018
Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers at Kocaeli University in Turkey compared the performance of conventional fluid management (CFM) to goal-directed fluid management (GDFM) using Masimo PVi® (pleth variability index, measured noninvasively and continuously using SET® pulse oximetry sensors) in patients undergoing elective colorectal surgery. The primary points of comparison were the amount of crystalloids administered and blood lactate and serum creatinine levels during the intraoperative period.1
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Masimo Radical-7® with PVi®, SpHb®, and RD rainbow SET™ Sensor (Photo: Business Wire)
In the study, Dr. Cesur and colleagues, noting the importance of intraoperative fluid management in terms of postoperative organ perfusion and complications, sought to compare the effects of CFM (guided by clinical assessment and heart rate, arterial blood pressure, and invasively measured central venous pressure) with GDFM (guided by clinical assessment and noninvasive Masimo PVi monitoring). They enrolled 70 ASA I-II adult patients undergoing elective colorectal tumor surgery, who were divided randomly into CFM and GDFM groups. PVi was measured using a Masimo Radical-7® Pulse CO-Oximeter® with software version 18.104.22.168 and SET® sensors. In the CFM group, an NaCl solution was administered at the rate of 4-8 ml/kg/h; when mean arterial pressure (MAP) fell below 65 mmHg or 30% baseline MAP, the speed of infusion was increased, colloid was initiated, and ephedrine was administered. In the GDFM group, the same solution was administered at the rate of 2 ml/kg/h; if PVi rose above 13% for more than 5 minutes, colloid and then ephedrine were administered. Treatments in both groups were continued until values were restored to each protocol’s pre-treatment threshold.
The researchers found that intraoperative crystalloid administration, urine output, and end-surgery fluid balance were significantly lower in the GDFM (PVi) group:
|Characteristic||Median value (25-75 percentile values): CFM group||Median value (25-75 percentile values): GDFM (PVi) group||P-value|
|Intraoperative Crystalloid administration||1946 ml (1500-2500 ml)||900 ml (800-1060 ml)||<0.001|
|Urine output||400 ml (250-600 ml)||300 ml (200-400 ml)||0.018|
|End-surgery fluid balance||1400 ml (960-2250 ml)||620 ml (410-1000 ml)||<0.001|
Durations of anesthesia and of surgery, as well as the amounts of intraoperative bleeding and administered colloid, were similar. The length of hospital stay was also found to be similar between the two groups.
The researchers noted that a limitation of the study was that they chose the number of subjects based on the needs of their primary objective, the comparison of intraoperative fluid volume between the two protocols, so they may not have evaluated enough subjects to effectively compare secondary outcomes such as length of stay: “We determined the primary goal of this study as the amount of intraoperative fluid volume and established 35 patients were needed for each group; if postoperative complications, the length of hospital stay[, were] determined as the primary goal, perhaps our numbers [in] each group [w]ould be different.”
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Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect® (MOC-9®) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at http://www.masimo.com/evidence/featured-studies/feature/.
ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.
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 include, among others, statements regarding the potential effectiveness of Masimo PVi®. 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 Masimo PVi, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; 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.