Study Investigates the Utility of Masimo ORi™, Oxygen Reserve Index, to Reduce Hyperoxia in Critically Ill Patients

Masimo (NASDAQ: MASI) announced today that in a randomized controlled study involving 150 ICU patients recently published as a letter in Intensive Care Medicine, researchers investigated whether monitoring with Masimo ORi™ (Oxygen Reserve Index) could reduce the time critically ill patients spend with moderate hyperoxia, compared to monitoring with oxygen saturation (SpO₂) alone.¹ ORi is an index of oxygenation in the moderate hyperoxic region, defined as arterial partial pressure of oxygen, PaO₂ , in the range of 100 to 200 mmHg). As an “index” with a scale between 0.0 and 1.0, ORi can be trended to notify clinicians of changes in a patient’s oxygen reserve.

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Dr. Sigismond Lasocki and colleagues at the Centre Hospitalier Universitaire of Angers, France (CHU Angers), sought to evaluate whether controlling the fraction of inspired oxygen (FiO₂) in mechanically ventilated patients based on monitoring with ORi, rather than with SpO₂ alone, could reduce the time patients spend in a moderately hyperoxic state (PaO₂ ≥ 100 mmHg). 150 critically ill adult patients, all of whom were mechanically ventilated for at least 2 days, were divided randomly into an ORi and a control group. ORi and SpO₂ were measured using the Masimo Root^® Patient Monitoring and Connectivity Platform and rainbow^® sensors. In the ORi group, nurses were instructed to decrease FiO₂ when ORi ≥ 0.01. In the control (SpO₂ only) group, they were instructed to decrease FiO₂ when SpO₂ ≥ a prescribed upper limit. PaO₂ was measured by analyzing arterial blood gasses.

Data from 75 patients in the ORi group and 71 patients in the control group were analyzed. The researchers found that monitoring with ORi allowed a statistically significant reduction in the percentage of days patients spent with hyperoxia without a statistically significant increase in hypoxia: 14% were hyperoxic (0 to 33%) in the ORi group vs. 33% (11 to 56%) in the control group (p = 0.003). The percentage of hours spent with hyperoxia was also “much lower” using ORi: 7.4% were hyperoxic (0 – 24.8%) in the ORi group vs. 17.3% (3.8 – 43.1%) in the control group for PaO2 ≥ 100 mmHg (p = 0.0069), and 0% (0 – 7.2%) in the ORi group vs. 5.6% (0 – 18.1%) in the control group for PaO2 ≥ 120 mmHg (p = 0.0037).

The researchers concluded that “The use of ORi monitoring to titrate oxygen rates allowed an important reduction of the time spent with hyperoxia compared with the use of SpO₂ alone, probably because nurses are reluctant to decrease oxygen rates when SpO₂ is in a normal range. A nurse-driven protocol to adjust FiO₂ according to SpO₂ was already in place in our unit, explaining why the percentage of time with hyperoxia we observed in the control group was much less than usually reported (30 vs 60%). This strategy to decrease oxygen rate according to ORi (which detects high PaO₂) may thus be even more efficient in units where there is no protocol to adjust oxygen rates. SpO₂ could remain a warning for hypoxia and ORi for hyperoxia. Larger studies are needed to evaluate the clinical benefit of this strategy.”

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.

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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 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.^5-7 Masimo SET^® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,⁸ and is the primary pulse oximetry at 9 of the top 10 hospitals listed in the 2019-20 U.S. News and World Report Best Hospitals Honor Roll.⁹ 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 Iris^® platform, and include Iris Gateway™, Patient SafetyNet, Replica™, Halo ION™, UniView™, and Doctella™. 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. Lasocki S, Brochant A, Leger M, Gaillard T, Lemarié P, Gergaud S, and Dupré P. ORi monitoring allows a reduction of time with hyperoxia in critically ill patients: the randomized control ORi study. Intensive Care Med. 13 Aug 2019. https://doi.org/10.1007/s00134-019-05732-9.
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 AH 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 SP 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. Estimate: Masimo data on file.
9. 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; 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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Contact information

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