Business Wire

New Study Evaluates the Utility of Masimo ORi™ in Reducing Hyperoxemia During Laparoscopic Gastrectomy

Share

Masimo (NASDAQ: MASI) today announced the findings of a prospective, double-blinded, randomized controlled study published in Medicine in which Dr. Jin Hee Ahn and colleagues at the Sungkyunkwan University School of Medicine in Seoul, Korea, evaluated the ability of Masimo ORi™ to assist clinicians in guiding supplemental oxygenation during elective laparoscopic gastrectomy surgery. The researchers found that the combination of ORi and standard of care oxygen saturation (SpO2) monitoring reduced hyperoxemia compared to SpO2 monitoring alone.1

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230220005333/en/

To view this piece of content from mms.businesswire.com, please give your consent at the top of this page.

Masimo Root® with ORi™ (Photo: Business Wire)

ORi, available outside the U.S. since 2014, is a noninvasive and continuous parameter intended to provide additional insight into a patient’s oxygen status under supplemental oxygen. Enabled by the multi-wavelength rainbow® Pulse CO-Oximetry platform, ORi is provided alongside SpO2 measured by clinically proven Masimo SET® pulse oximetry.

Noting that the use of supplemental oxygen during general surgery increases the risk of hyperoxemia, the researchers sought to evaluate whether noninvasive, continuous ORi might improve clinicians’ ability to detect hyperoxemia, since SpO2 monitoring alone cannot monitor beyond 100% saturation, and since arterial blood gas analysis has the disadvantages of being invasive and giving intermittent, delayed results. To test their hypothesis, the researchers randomly allocated 62 adult patients scheduled for elective laparoscopic gastrectomy into two groups, one whose fraction of inspired oxygen (FiO2) during anesthesia was guided by ORi and SpO2 monitoring (the ORi-SpO2 group, n=30), and a control group whose FiO2 was guided by SpO2 monitoring alone (the SpO2 group, n=32). Patients in both groups were monitored with Masimo Radical-7® Pulse CO-Oximeters® with rainbow® sensors. In addition to Masimo ORi and SET® SpO2, Masimo PVi® (pleth variability index) was monitored as part of goal-directed fluid management.

In the ORi-SpO2 group, FiO2 was adjusted to maintain ORi > 0 and < 0.3, which was evaluated every 2 to 3 minutes throughout surgery. In the SpO2 group, FiO2 was adjusted to maintain SpO2 ≥ 98%, similarly evaluated every 2 to 3 minutes. To assess the incidence of hyperoxemia, the clinicians recorded the arterial partial pressure of oxygen (PaO2), measured using an ABL-90 FLEX Plus blood gas analyzer, before surgical incision and one, two, and three hours after surgical incision. Hyperoxemia was defined as PaO2 ≥ 100 mmHg and severe hyperoxemia as PaO2 ≥ 200 mmHg.

The researchers found that one hour after surgical incision, PaO2 was higher in the SpO2 group (250.31 ± 57.39 mmHg) than in the ORi-SpO2 group (170.07 ± 49.39 mmHg) (p < .001), and remained consistently higher in the SpO2 group than in the ORi-SpO2 group over time (p = .045). The rate of severe hyperoxemia was higher in the SpO2 group (84.4%) than in the ORi-SpO2 group (16.7%) 1 hour after incision (p < .001).

The researchers concluded, “[I]ntraoperative hyperoxemia was reduced when FiO2 was adjusted based on the combination of SpO2 and ORi compared with SpO2 alone in patients undergoing laparoscopic gastrectomy.”

ORi has not yet received FDA clearance and is not available in the United States.

@Masimo | #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.2 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,3 improve CCHD screening in newborns,4 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.5-8 Masimo SET® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,9 and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.10 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®), RPVi™ (rainbow® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine® Brain Function Monitoring, O3® Regional Oximetry, and ISA™ Capnography with NomoLine® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7®, Radius PPG®, and Radius VSM™, portable devices like Rad-67®, fingertip pulse oximeters like MightySat® Rx, and devices available for use both in the hospital and at home, such as Rad-97®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris® Gateway, iSirona™, Patient SafetyNet, Replica®, Halo ION®, UniView®, UniView :60™, and Masimo SafetyNet®. Its growing portfolio of health and wellness solutions includes Radius Tº® and the Masimo W1™ watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.

ORi, RPVi, and Radius VSM have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

  1. Ahn JH, Shim J-G, Park J, Lee SH, Ryu K-H, Cho E-A. Oxygen reserve index guided fraction of inspired oxygen titration to reduce hyperoxemia during laparoscopic gastrectomy: A randomized controlled trial. Medicine. October 2022. DOI: 10.1097/MD.0000000000031592.
  2. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
  3. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
  4. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
  5. Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
  6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
  7. McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
  8. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
  9. Estimate: Masimo data on file.
  10. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

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 ORi™, SET®, rainbow®, and Radical-7®. 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 ORi, SET®, rainbow®, and Radical-7®, contribute to positive clinical outcomes and patient safety; risks that the researchers’ conclusions and findings may be inaccurate; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; 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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Media Contact:
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Hoffmann Green Announces a Historic Increase in Production Over the First Half of 2025, Already Outperforming the Annual Volumes Realized in 20242.7.2025 20:05:00 EEST | Press release

Hoffmann Green Cement Technologies (ISIN: FR0013451044, Ticker: ALHGR) (“Hoffmann Green Cement” or the “Company”), an industrial player committed to the decarbonation of the construction sector that designs and markets innovative clinker-free cements, today announces a strong acceleration of production over the first half of 2025, validating the relevance of its industrial and commercial business model. Production volumes reached 19,640 tonnes over the first half of 2025, compared with 7,833 tonnes in the first half of 2024, representing a 2.5-fold increase. This very strong level of activity enabled the Company to outperform its total 2024 volumes (16,269 tonnes) over the first half of 2025. This dynamic is illustrated by the supply of more than 130 construction sites across the country during the half-year, exceeding 60,000 m³ of concrete formulated with 0% clinker cement delivered by more than 10,000 truck mixers. Julien BLANCHARD and David HOFFMANN, Co-founders of Hoffmann Green Ce

Institutional Real Estate, Inc. Announces Acquisition of U.K.-based Lyndon Publishing 2 Limited2.7.2025 19:44:00 EEST | Press release

Institutional Real Estate, Inc. (“IREI”) has completed its acquisition of the assets of London-based Lyndon Publishing 2 Ltd (“Lyndon Publishing”), which include The Property ChronicleandThe Green Chronicle.The former Lyndon Publishing 2 will now operate as a division of IREI. The Property Chronicle reaches a global audience of real estate investment professionals, researchers, and academics. Its sister publication, The Green Chronicle, is edited to address the interests and concerns of emerging young talent in these real estate professions. Both publications are produced as weekly news briefings filled with original content and contributed feature articles from industry thought and opinion leaders. In addition, The Property Chronicle is also published as a quarterly, illustrated full-color magazine available in both digital and print formats, while The Green Chronicleis published exclusively in digital format. Together, the two publications reach approximately 50,000 professionals acr

Sinopec Wins Technological Innovation Award at 2 nd Sino-European Corporate ESG Best Practice Conference2.7.2025 19:21:00 EEST | Press release

China Petroleum & Chemical Corporation ("Sinopec", HKG: 0386) has won the "Best Scientific and Technological Innovation Practice" award at the 2nd Sino-European Corporate ESG Best Practice Conference (the "Conference") on June 26 in Stuttgart. Sinopec’s case submission of Breakthrough in Depth, Climb to New Heights — Empowering the Energy and Chemical Industry with Technological Innovation stood out among numerous entries. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702387465/en/ Wang Tao, Sinopec representative, delivered a speech at the conference. The Conference reviews and awards the best ESG application cases in six areas of environmental protection, social responsibility, corporate management, scientific and technological innovation, education, and training to further enhance mutual understanding between Chinese and European businesses, facilitate bilateral economic and trade exchanges, and showcase China’s open,

Xsolla Releases Their Q2 2025 The State of Play Report: Mobile Gaming Is Projected to Hit $126B in 2025 Amid Global App Boom With In-Depth Analysis of Trends, Genres, and Monetization Strategies2.7.2025 19:00:00 EEST | Press release

Xsolla, a leading global video game commerce company, proudly announces the release of the Q2 2025 Edition of “The Xsolla Report: The State of Play.” This detailed report provides crucial insights, trends, and opportunities shaping the gaming landscape, empowering industry professionals to adapt and thrive in today’s rapidly changing market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250702208715/en/ Graphic: Xsolla In 2024, global mobile app usage soared to an astonishing 4.2 trillion hours, an all-time high that powered a massive $150 billion consumer spending across mobile platforms. Mobile gaming is leading this charge, which accounted for more than half of that total. Despite a 6% dip in overall game downloads, falling to 49.6 billion, in-app purchase (IAP) revenue surged, indicating deeper user engagement and a more valuable player base. And the momentum is far from over: mobile gaming revenue is projected to grow

LambdaTest Announces Deeper Collaboration with Appium as Strategic Partnership2.7.2025 18:00:00 EEST | Press release

LambdaTest, a unified agentic AI and cloud engineering platform, has announced it has become a strategic sponsor of Appium, the world’s most widely used open-source framework for mobile automation. This collaboration aims to significantly simplify and accelerate mobile test automation by integrating Appium’s capabilities into LambdaTest’s cloud-based distributed testing platform. LambdaTest has an active open-source program that provides access to LambdaTest’s testing infrastructure to community projects, so maintainers can run comprehensive test suites without worrying about servers or setup. The organization had also launched LambdaTest Grants for Open Source to support innovation in software testing frameworks and toolsets. As part of the Grants, LambdaTest had announced a $250,000 grant for open source projects and contributors building solutions for the QA and Testing community. With this Appium Strategic Partnership, LambdaTest is doubling down on the commitment made to the open

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye