SOURCE: Masimo

Masimo

November 05, 2013 11:22 ET

New Published Clinical Study Shows Masimo PVI® Helps Clinicians Assess Fluid Responsiveness in Ventilated Patients in the Early Phase of Septic Shock

IRVINE, CA--(Marketwired - Nov 5, 2013) -   Masimo (NASDAQ: MASI) announced today a new study in the Journal of Critical Care demonstrates that Masimo's noninvasive PVI® can be used to help clinicians accurately assess fluid responsiveness in mechanically ventilated patients in the early phase of septic shock in the emergency room.1

Early, goal-directed treatment of sepsis is particularly important and is recommended by the Surviving Sepsis guidelines, but these efforts can be complicated if dynamic invasive monitoring tools are not readily available.

In the study conducted at Centre Hospitalier de Belfort-Montbeliard in Belfort, France, Marc Feissel, M.D., and a team of researchers evaluated 31 mechanically ventilated and sedated adult patients with septic shock in whom volume expansion was planned. Investigators used a Masimo Radical-7 Pulse CO-Oximeter®, which automatically calculated and displayed PVI. Intervention consisted of infusing 8 mL/kg of hydroxylethyl starch over a 20-minute period. Before and after intervention, researchers recorded PVI and measured the aortic velocity-time integral (VTIao) using transthoracic echocardiography.

Sixteen patients were classified as responders; 15 as nonresponders. Responders were defined as patients who increased their VTIao by 15% or higher after fluid infusion. Mean PVI values before intervention were significantly higher in responders vs nonresponders (30% ± 9% vs 8% ± 5%, P < .001). PVI values before intervention were correlated with percent changes in VTIao induced by intervention (r=0.82, r2 = 0.67; P < .001).

A PVI threshold value of 19% distinguishes responders from nonresponders to fluid challenge with a sensitivity of 94% and a specificity of 87% in mechanically ventilated patients in the early phase of septic shock.

The researchers concluded that PVI is a "feasible and interesting method to predict fluid responsiveness in the early phase septic shock patients."

Investigators also noted, "Training emergency department physicians in the use and interpretation of PVI is quick, easy, and inexpensive;" "removing the need for central arterial catheter placement in the emergency department represents a considerable time gain and avoids an additional puncture site that could be a potential port of entry for bacteria;" and, "optimizing hemodynamic status as early as possible, that is, in the emergency department, could help avoid progression to multi-organ failure, thereby reducing morbidity and mortality in patients with severe sepsis or septic shock."

PVI is a dynamic noninvasive measurement of changes over the respiratory cycle that 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.2-6

Steve Barker, M.D., Ph.D., Interim Chief Medical Officer of Masimo, stated: "This study demonstrates the practical and cost-effective advantage of PVI, particularly for physicians for whom time and ease of use are of the essence. The findings also add to the growing body of evidence that shows the efficacy of PVI across a wide range of patient populations."

1 Feissel M., Kalakhy R., Banwarth P., Badie J., Pavon A., Faller J., Quenot J.; "Plethysmographic variation index predicts fluid responsiveness in ventilated patients in the early phase of septic shock in the emergency department: A pilot study." J Crit Care 2013 Oct; 28(5): 634-639.
2 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.
3 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.
4 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.
5 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.
6 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.

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 help clinicians 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 ® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously required invasive procedures; total hemoglobin (SpHb®), oxygen content (SpOC), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI®, and perfusion index (PI), in addition to measure-through motion SpO2, and pulse rate. 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 commercially available noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo SET® and Masimo rainbow® technologies also can be 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 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.

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, Adaptive Threshold Alarm, and SedLine are trademarks or registered trademarks of Masimo Corporation. The use of the trademarks Patient SafetyNet and PSN are under license from University HealthSystem Consortium.

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