New Clinical Study Shows Masimo Corporation PVI® Helps Clinicians Optimize Fluid Administration In Patients Under Combined General And Epidural Anesthesia

Published: Apr 08, 2014

IRVINE, CA--(Marketwired - April 07, 2014) -

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Masimo (NASDAQ: MASI) announced today a recent study in the Journal of Monitoring and Computing demonstrates that Masimo's noninvasive PVI® parameter can help clinicians optimize fluid management and reduce unnecessary fluid administration for abdominal surgical patients under combined general and epidural anesthesia.(1)

Combining general and epidural anesthesia reduces the need for general anesthetics and can reduce risks of respiratory complications and time of stay in hospitals, but the occurrence and severity of hypotension (low blood pressure) are higher compared to general anesthesia alone without proper fluid management.(2-4) Too little fluid administration can result in low perfusion in peripheral tissue, but too much fluid administration can result in fluid overload postoperatively.(5,6) Traditional management approaches to guide fluid administration including central venous pressure (CVP) monitoring are not considered reliable.(7) Instead of so-called "static" parameters such as CVP, experts recommend the use of "dynamic" parameters that measure variations over the respiratory cycle. Multiple dynamic parameters have been shown to help clinicians predict fluid responsiveness and improve fluid management, but most dynamic parameters require invasive and/or complex methods. In contrast, PVI is noninvasive and easily obtained with any Masimo SET® or rainbow® sensor. PVI provides clinicians with a continuous, easy-to-use, and cost-effective measure for assessing whether patients will benefit from fluid administration -- enabling personalized and goal-directed fluid therapy.(8-12)

In the study conducted at Shanghai First People's Hospital in Shanghai, China, Yinan Yu, M.D., and a team of researchers assessed the impact of PVI as a goal-directed fluid parameter on tissue perfusion for 30 patients who underwent elective abdominal surgery while administered combined general and epidural anesthesia (GEN-EPI). Investigators used a Masimo Radical-7 rainbow SET Pulse CO-Oximeter®, which automatically calculated and displayed PVI.

The total average amount of fluid infused in PVI-guided fluid therapy group was significantly lower than the amount of fluid in the control group (1,918 +/- 437 mL vs. 2,327 +/- 463 mL, P < 0.05). The total amount of crystalloid fluid received in the PVI group also was greatly less than that of the control group (1,355 +/- 383 mL vs. 1,715 +/- 406 mL, P < 0.05). Moreover, there were significantly lower blood lactate levels during the first hour of the surgery between the PVI group (0.81 +/- 0.30 mmol//L) and the control group (1.18 +/- 0.32 mmol/L), P < 0.05.

The researchers noted that higher blood lactate levels in the perioperative period recently have been shown to be related with postoperative complications and the average hospitalization time.(13)

The researchers concluded: "PVI-based goal-directed fluid management in major abdominal surgery patients under GEN-EPI can reduce the amount of fluids administration, especially the crystalloid administration, and the blood lactate levels during surgery. Furthermore, the first hour following GEN-EPI is the critical period for anesthesiologists to optimize the fluid therapy."

Steve Barker, M.D., Ph.D., Chairman of the Scientific Advisory Board of Masimo, stated: "This study demonstrates the clinical advantage of PVI in optimizing fluid management and reducing unnecessary fluid administration for a significant population of patients, and adds to the growing body of evidence that shows how PVI -- by aiding clinicians in understanding fluid levels of their patients -- can improve patient outcomes while helping to reduce costs."

1 Yu Y, Dong J, Xu Z, Shen H, Zheng J. "Pleth variability index-directed fluid management in abdominal surgery under combined general and epidural anesthesia." J Clin Monit Comput 2014 Feb; DOI 10.1007/s10877-014-9567-5. Available online here.
2 Zhao W, Zhou R, Zhou LP, Li CH. The hemodynamic effects during thoracic epidural anesthesia combined with general anesthesia in patients undergoing major abdominal operations. Zhonghua wai ke za zhi [Chin J Surg]. 2009;47(11):849-52.
3 Gurses E, Berk D, Sungurtekin H, Mete A, Serin S. Effects of high thoracic epidural anesthesia on mixed venous oxygen saturation in coronary artery bypass grafting surgery. Med Sci Monit Int Med J Exp Clin Res. 2013;19:222-9. doi:10.12659/MSM.883861.
4 Shin S, Bai SJ, Rha KH, So Y, Oh YJ. The effects of combined epidural and general anesthesia on the autonomic nervous system and bioavailability of nitric oxide in patients undergoing laparoscopic pelvic surgery. Surg Endosc. 2013;27(3):918-26. doi:10.
1007/s00464-012-2536-5.
5 Kita T, Mammoto T, Kishi Y. Fluid management and postoperative respiratory disturbances in patients with transthoracic esophagectomy for carcinoma. J Clin Anesth. 2002;14(4):252-6.
6 Brandstrup B, Tonnesen H, Beier-Holgersen R, Hjortso E, Ording H, Lindorff-Larsen K, Rasmussen MS, Lanng C, Wallin L, Iversen LH, Gramkow CS, Okholm M, Blemmer T, Svendsen PE, Rottensten HH, Thage B, Riis J, Jeppesen IS, Teilum D, Christensen AM, Graungaard B, Pott F, Danish Study Group on Perioperative Fluid T. Effects of intravenous fluid restriction on postoperative complications: comparison of two perioperative fluid regimens: a randomized assessor-blinded multicenter trial. Ann Surg. 2003;238(5):641-8. doi:10.1097/01.sla.0000094387.50865.23.
7 Vallet B., Blanloeil Y., Cholley B., Orliaguet G., Pierre S., Tavernier B. "Strategy for perioperative vascular filling - Guidelines for perioperative haemodynamic optimization." Experts' Formalized Recommendations, French Society of Anaesthesia and Intensive Care (SFAR), Validation by the administrative council of SFAR on 19 October 2012. Available here.
8 Loupec T., Nandoumgar H., Frasca D., Petitpas F., Laksiri L., Baudouin D., Debaene B., Dahyot-Fizelier C., Mimoz O. "Pleth Variability Index Predicts Fluid Responsiveness in Critically-Ill Patients." Crit Care Med 2011 Feb;39(2):294-9. Available online here.
9 Zimmerman M., Feibicke T., Keyl C., Prasser C., Moritz S., Graf B., and Wiesenack C. "Accuracy of Stroke Volume Variation Compared with Pleth Variability Index to Predict Fluid Responsiveness in Mechanically-ventilated Patients Undergoing Major Surgery." Eur J Anaesthesiol. 2010 Jun;27(6):555-61. Available online here.
10 Feissel M., Kalakhy R., Badie J., Robles G., Faller J., Teboul JL. "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.
11 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." Br J Anaesth. 2008 Aug;101(2):200-6. Available online here.
12 Forget P, Lois F, De Kock M. "Goal-Directed Fluid Management Based on the Pulse Oximeter-Derived Pleth Variability Index Reduces Lactate Levels and Improves Fluid Management." Anesth Analg. 2010 Oct;111(4):910-4. Published online here.
13 Bakker J, Nijsten MW, Jansen TC. Clinical use of lactate monitoring in critically ill patients. Ann Intensive Care. 2013;3(1):12. doi:10.1186/2110-5820-3-12.

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 have shown that Masimo SET® outperforms other pulse oximetry technologies, 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 could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and PVI®, in addition to SpO2, pulse rate, and perfusion index (PI). 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 of the repeatability of clinical results obtained using Masimo PVI, risks related to our belief that PVI is an easy-to-use and cost-effective measure for assessing whether patients will benefit from fluid administration, risks related to our assumptions that PVI enables personalized and goal-directed fluid therapy, and that PVI is a preferred noninvasive indicator of fluid responsiveness in children, 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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