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Masimo’s rainbow® Acoustic Monitoring (RAM™) was Associated with Fewer Alarm Events During Planned Moderate Sedation in New Clinical Study

02/12/16

For Breath Rates Less Than or Equal to 4 Breaths Per Minute, RAM Showed 78% True Positives and 22% False Positives, While Capnography Showed 30% True Positives and 70% False Positives

IRVINE, Calif.--(BUSINESS WIRE)--Feb. 12, 2016-- Masimo (NASDAQ: MASI) announced today that Masimo’s rainbow® Acoustic Monitoring (RAM™) was associated with fewer alarm events during planned moderate sedation in a new clinical study.1

This two-part pilot study used RAM and SedLine® brain function monitoring as the additional monitoring parameters during planned moderate sedation to (1) determine the incidences of alarm events (desaturation, respiratory depression and deeper than intended sedation), and (2) determine whether monitoring with these parameters is associated with fewer alarm events.

RAM noninvasively and continuously measures respiration rate using an innovative adhesive sensor with an integrated acoustic transducer that is applied to the patient’s neck.

In the two-part study, published in the journal Anesthesia & Analgesia by Dr. Richard Applegate II and colleagues from the Loma Linda University School of Medicine, data were collected from adult patients undergoing gastroenterology or interventional radiology procedures under moderate sedation. The patients were monitored per standard protocols (electrocardiography, blood pressure, pulse oximetry, and capnography) along with the additional parameters RAM and SedLine. RAM and SedLine were not visible to the care teams in part one of the study (standard) but were visible to the care teams in part two of the study (advanced). Alarm events were defined as desaturation (SpO2 ≤92%), acoustic respiration rate ≤8 breaths per minute, and PSI ≤50.

Data were analyzed from 90 patients (44 standard and 46 advanced). There were 55% fewer alarm events in advanced patients compared with standard patients (median 2.5 vs. 5.5, p=0.038). Fewer advanced patients had ≥1 respiratory depression event (17 vs 26; p=0.035) or ≥1 desaturation event (15 vs 25; p=0.02).

The investigators also compared respiratory rate events between capnography (using the Covidien Capnostream™ 20p) and RAM in the standard group and conducted a retrospective analysis to determine the true positive rates for capnography and RAM. The true positive rates were 30% and 78% respectively; the false positive rates were 70% and 22% respectively.

There were no significant differences between groups in the number of deeper than intended sedation events using SedLine.

The authors concluded that “the use of advanced monitoring during planned moderate sedation was associated with fewer alarm events, patients experiencing desaturation, and patients experiencing respiratory depression alarm events. … The findings of this pilot study suggest that further study into the safety and outcome impacts of advanced monitoring during procedure-related sedation is warranted.”

For more information on RAM and SedLine, go to www.masimo.com.

@MasimoInnovates | #Masimo

1 Applegate RL II, Lenart J, Malkin M, Meineke MN, Qoshlli S, Neumann M, Jacobson JP, Kruger A, Ching J, Hassanian M, Um M. Advanced Monitoring Is Associated with Fewer Alarm Events During Planned Moderate Procedure-Related Sedation: A 2-Part Pilot Trial. Anesth Analg. 2016 Feb 1. [Epub ahead of print].

About Masimo

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 by taking noninvasive monitoring to new sites and applications. 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. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. 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®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI™), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive open architecture patient monitoring and connectivity platform designed to speed the pace of innovation and reduce the cost of care. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor and the MightySat™ fingertip pulse oximeter. 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 include, among others, statements regarding the potential effectiveness of Masimo’s rainbow® Acoustic Monitoring (RAM™) and SedLine® brain function monitoring technologies. 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 Root® with SedLine® and RAM™, 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.

Source: Masimo

Masimo
Irene Paigah, 858-859-7001
irenep@masimo.com