Business Wire

New Study Investigates the Impact of ORi-Guided Oxygen Titration on Hyperoxemia-Mediated Morbidity During One-Lung Ventilation

Share

Masimo (NASDAQ: MASI) announced today the findings of a study published in the Turkish Journal of Medical Sciences in which Dr. Ayten Saracoglu and colleagues at the Marmara University Pendik Training and Research Hospital in Istanbul evaluated the ability of ORi to guide oxygenation by measuring its impact on hyperoxemia-mediated morbidity during one-lung ventilation (OLV) conducted as part of thoracic surgery.1 They concluded that ORi-guided oxygen titration “may reduce hospital stay and increase patient safety.”

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210613005039/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 oxygen saturation (SpO2) measured by clinically proven Masimo SET® pulse oximetry.

Noting that during OLV, a common technique for facilitating a wide variety of pulmonary procedures, 100% fraction of inspired oxygen (FiO2) supplemental oxygen administration is commonly used, which exposes patients to the possibility of hyperoxia-induced lung injury, the researchers sought to determine whether ORi could “protect patient from the harmful effects of hyperoxemia with a noninvasive probe during OLV.” They divided 103 patients with lung tumors (18-70 years of age, ASA I-III), enrolled between September 2018 and September 2019 and requiring OLV as part of elective thoracic surgery, into four groups as noted below:

Group

Number
of
Subjects

Duration of
OLV with
FiO2 > 60%

Mean FiO2
values

1: Oxygen titration without ORi, low-flow anesthesia (1 L/min)

25

67.6 ± 97.5 mins.

71.6 ± 12.25%

2: Oxygen titration without ORi, high-flow anesthesia (4 L/min)

28

97.32 ± 99.7 mins.

74.64 ± 16.66%

3: Oxygen titration with ORi, low-flow anesthesia (1 L/min)

25

39.2 ± 74.1 mins.

62.8 ± 13.08%

4: Oxygen titration with ORi, high-flow anesthesia (4 L/min)

25

22.4 ± 49.4 mins.

56.4 ± 11.5%

During OLV, oxygen titration was performed without ORi for patients in groups 1 and 2, while groups 3 and 4 used ORi from Masimo Radical-7® Pulse CO-Oximeters® and rainbow® sensors. For all 4 groups, SpO2 and partial pressure of arterial oxygen (PaO2) were routinely measured while FiO2 was routinely administered at 50% after induction, rising to 60% when the OLV was applied, and increasing to 70%-100% as necessary.

The researchers found that ORi monitoring was associated with significantly shorter duration of OLV with FiO2 > 60%, with significantly lower mean FiO2 values during OLV (as shown in the table above), and with lower recorded PaO2 values. They also found that the duration of FiO2 > 80% during OLV was strongly correlated with longer hospital stays (p < 0.001).

The observation that mean FiO2 values were found to be significantly lower in the ORi groups (3 and 4), compared to the groups without ORi (1 and 2), led the researchers to hypothesize that “the risk of hyperoxia will be lower in patients undergoing ORi monitor[ing].” The researchers noted, “ORi cannot replace arterial blood gas analysis; however, it is useful to assess oxygenation. In groups without ORi monitors, the FiO2 was significantly higher than 80%. Moreover, in our study, it was revealed that these patients had a longer hospital stay.”

There was no significant difference in ORi values between the low-flow (group 3) and high-flow (group 4) cohorts.

The researchers concluded, “The adjustment of ORi with peripheral oxygen saturation and blood gas analysis demonstrated that hyperoxemia could be prevented during OLV in patients under low flow or high flow anesthesia. We concluded that ORi-guided thoracic anesthesia may reduce hospital stay and increase patient safety.”

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. Our mission is to improve patient outcomes, reduce the cost of care, and take noninvasive monitoring to new sites and applications. 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 according to the 2020-21 U.S. News and World Report Best Hospitals Honor Roll.10 Masimo continues to refine SET® and in 2018, announced that SpO2 accuracy on RD SET® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient’s physiological status. 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® and Radius PPG™, 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 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™. 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 and RPVi 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. Saracoglu A, Yamansavci Şirzai E, Yildizeli B, Yüksel M, Aykaç ZZ. Oxygen Reserve Index Guided Oxygen Titration in One Lung Ventilation with Low Fresh Gas Glow. Turkish Journal of Medical Sciences. 2021 May. DOI: 10.3906/sag-2009-149.
  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™. 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, 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; 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

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

About Business Wire

Business Wire
Business Wire



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

Prosus FAQ's Regarding the Voluntary Share Exchange Offer to the Holders of Naspers N Ordinary Shares30.7.2021 19:00:00 CEST | Press release

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO ANY JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. PLEASE SEE THE IMPORTANT DISCLAIMERS AT THE END OF THIS ANNOUNCEMENT. Shareholders are referred to the prospectus (Prospectus) published by Prosus N.V. (Prosus) on 12 July 2021 in respect of the voluntary share exchange offer by Prosus to Naspers (JSE:NPN) (LSE:NPSN) N Shareholders (Exchange Offer). Further to the announcement issued by Prosus today, shareholders are advised that since the publication of the Prospectus Prosus has received certain frequently asked questions regarding the Exchange Offer and has therefore made certain materials available today at www.share-exchange-offer.com, where these frequently asked questions have been addressed by Prosus. Cape Town South Africa 30 July 2021 About Naspers Established in 1915, Naspers has transformed itself to become a global consumer internet compan

Prosus FAQ's Regarding the Voluntary Share Exchange Offer to the Holders of Naspers N Ordinary Shares30.7.2021 18:59:00 CEST | Press release

Shareholders are referred to the prospectus (Prospectus) published by Prosus on 12 July 2021 in respect of the voluntary share exchange offer by Prosus to Naspers N Shareholders (Exchange Offer). Since the publication of the Prospectus Prosus has received certain frequently asked questions regarding the Exchange Offer and has therefore made certain materials available today at www.share-exchange-offer.com, where these frequently asked questions have been addressed. About Prosus Prosus is a global consumer internet group and one of the largest technology investors in the world. Operating and investing globally in markets with long-term growth potential, Prosus builds leading consumer internet companies that empower people and enrich communities. The group is focused on building meaningful businesses in the online classifieds, food delivery, payments and fintech, and education technology sectors in markets including India, Russia, and Brazil. Through its ventures team, Prosus invests in

I’mbesideyou Inc. Launched “UNION OF EMOTIONS” Service Using AI to Visualize Cheering Each Other Across National Borders30.7.2021 16:25:00 CEST | Press release

I’mbesideyou Inc. (Setagaya-ku, Tokyo CEO: Shozo Kamiya, hereinafter referred to as I'mbesideyou) launched the "UNION OF EMOTIONS" service on July 23, 2021, the opening day of an international sporting event. This is the first time we have been able to visualize people cheering each other with emotion analysis AI. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210730005404/en/ A visualization of the emotions of cheers flying around the world: Click on each cheer to learn more about that country. (Photo: Business Wire) More than 20,000 cheers have already been sent from more than 79 cities across more than 14 countries around the world, and the sight of the cheers flying across the globe has moved many people on social media. UNION OF EMOTIONS, is the world's first example of people's emotions connecting in real time across countries with the help of AI. It is scheduled to be available until August 8, when the closing ceremon

Palace Bidco Oy (“WSIP Bidco”) Has Received Necessary Regulatory Approval Concerning the Recommended Cash Offer to the Shareholders of Adapteo Plc (“Adapteo”)30.7.2021 14:23:00 CEST | Press release

This announcement is not an offer, whether directly or indirectly, in Australia, Canada, Hong Kong, Japan, New Zealand or South Africa or in any other jurisdiction where such offer pursuant to legislation and regulations in such relevant jurisdiction would be prohibited by applicable law. Shareholders not resident in Sweden or Finland who wish to accept the Offer (as defined below) must make inquiries concerning applicable legislation and possible tax consequences. Shareholders should refer to the offer restrictions included in the section titled “Important information” at the end of this announcement and in the offer document which was published on 23 June 2021. Shareholders in the United States should also refer to the section titled “Special notice to shareholders in the United States” at the end of this announcement and in the offer document. On 17 May 2021, WSIP Bidco, a private limited liability company formed on behalf of, and indirectly wholly owned by, West Street Global Infra

Taipei Exchange Launches Pioneer Stock Board to Support Innovative Enterprises30.7.2021 10:00:00 CEST | Press release

The Taipei Exchange, TPEx, launched Pioneer Stock Board (PSB) on July 20, 2021, which welcomed its first company on July 26. Pioneer Stock Board marks the evolution of the stock market into an innovation-friendly ecosystem. It aims to facilitate entry to capital markets for more innovative enterprises. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210730005008/en/ Taipei Exchange launches Pioneer Stock Board to support innovative enterprises (Photo: Business Wire) At the PSB Launch Ceremony, Premier Su Tseng-chang delivered the opening speech, emphasizing the government’s support. Su said, “Taiwan’s capital market breaks new ground today, by establishing this board. PSB will support innovative enterprises, a key driver of economic transformation, by providing companies with quick access to capital needed for continued growth.” Dr. Tien-mu Huang, Chairperson of Financial Supervisory Commission, remarked, “Innovation underpin

ITRS Group Continues Expansion With the Acquisition Of Opsview30.7.2021 10:00:00 CEST | Press release

ITRS Group, a leading provider of real-time monitoring and analytics software, has acquired 100% of Opsview Limited, a modern, scalable monitoring platform, which provides unified insight into dynamic IT operations on-premises, in the Cloud or hybrid. Opsview will remain and operate as a separate brand and entity. The purchase of Opsview aligns well with ITRS’ strategy to build, buy and partner to deliver smart, automated and predictive end-to-end monitoring solutions for increasingly complex IT estates across industries. This development follows the successful strategic acquisitions of Sumerian, OP5 and Uptrends. Guy Warren, CEO of ITRS commented: “Opsview is trusted by hundreds of businesses, government organisations and service providers globally. This acquisition will enhance our technological innovation, increase our portfolio capability, and provide continued expansion across our global support services.” Mike Walton, CEO and founder of Opsview said: “Partnering with ITRS represe

Schneider Electric Moves Forward With Its Sustainability Impact Targets, Mobilizing Support From Employees, Partners and Customers30.7.2021 08:32:00 CEST | Press release

Schneider Electric, the leader in the digital transformation of energy management and automation, published today its half-year progress overview on setting up and advancing on its 2021-2025 sustainability impact targets. Schneider Electric, named as the world’s most sustainable corporation 2021 by the Corporate Knights Global 100 Index, announced the acceleration of its sustainability strategy in January, aligned to its commitments regarding climate, resources, trust, equal opportunities, generations, and local communities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210729006295/en/ Schneider Sustainability Impact - H1 Results (Graphic: Business Wire) Since then, the Group has successfully launched The Zero Carbon Project, its initiative to halve carbon emissions of its top supply chain partners by 2025, a call to action already joined by 91% of them. By engaging, training, and supporting the sustainable transformation

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