Masimo Rad-G® Helps Clinicians Identify Pediatric Pneumonia in Large Field Trial in India

(BUSINESS WIRE)-- Masimo (NASDAQ: MASI) today announced the findings of a study published in Clinical Medicine Insights: Pediatrics in which Dr. Harish Kumar and colleagues at IPE Global in New Delhi, India reported on their experience using the Masimo Rad-G^® Pulse Oximeter to aid health providers in pneumonia case detection and management in more than 4,500 children under five years who presented with symptoms of acute respiratory infection (ARI). Rad-G is a rugged, portable, handheld Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximeter and noninvasive respiration rate monitor from the pleth (RRp^®). The researchers found that Rad-G was “highly acceptable among health workers” and aided the “timely classification and treatment” of pneumonia—helping them achieve correct case management in more than 91% of cases of ARI and reduce the unnecessary use of antibiotics.¹

Study author Dr. Kumar commented, “Our decision to choose Rad-G as our pulse oximeter of choice to aid HWCs in pneumonia screening proved to be a good one. The device is easy to use and maintain, even in low-resource settings, and because of its ability to accurately and reliably measure SpO₂ and RR, it has the potential to transform the identification and management of pneumonia by healthcare workers, even those who may not be medical doctors. We hope that our study will help convince many more Indian states of the value of integrating use of Rad-G and its technological benefits into their care practices, supporting nationwide efforts to successfully diagnose and treat as many cases of pediatric pneumonia as possible.”

As the authors note, pneumonia – one of the most common causes of ARI in children – contributes to 15% of child deaths across the world, with India accounting for 20% of those deaths. In low-resource health settings, where access to diagnostic aids is limited, health workers often rely on manual counts of respiratory rate to inform ARI management decisions. In this trial, researchers evaluated oxygen saturation (SpO₂) and respiratory rate (in accordance with WHO guidelines for effective pneumonia management) measured by Rad-G. Given the often “inadequate skills” of front-line healthcare workers in low-resource and rural settings—for example, it was found that the majority of workers at Indian Health and Wellness Centers (HWCs) “lacked knowledge on how to correctly assess a child with cough or difficult breathing”—the authors hoped that Rad-G could help workers more readily diagnose pneumonia, prove to offer good “usability,” and ultimately, contribute to India’s goal of aggressively reducing child deaths due to pneumonia.

The researchers chose Rad-G from among other available pulse oximeters for a variety of reasons, in particular its integration of respiration rate from the pleth (RRp) and accurate and reliable SpO₂. Before proceeding with this larger trial, an initial study at a single tertiary care hospital was conducted in 2019 to evaluate the accuracy of RRp on Rad-G. That study found a 97% association between Rad-G RRp and pediatrician-measured RR, with high sensitivity, specificity, and accuracy.² The authors also noted Rad-G’s long-lasting, rechargeable battery, its LCD display, and the fact that a single sensor could be used on all children under five years. Following the initial study, Rad-G was introduced at 19 HWCs across seven states in India, and its implementation and utility (including usability and durability) were tracked over 15 months, from June 2019 to August 2020. Over this period, a total of 4,846 children aged 2 – 60 months with symptoms of ARI visited the facilities. To aid in assessing cases, providers were given abridged training in India’s Integrated Management of Neonatal and Childhood Illnesses (IMNCI) program, which classifies children with ARI as having severe pneumonia (SpO₂ < 90% or presence of “general danger signs”), pneumonia (fast breathing or chest in-drawing), or neither (none of the above).

Of the 4,846 children, 0.1% were diagnosed with severe pneumonia and 23% with pneumonia. Reviewing cases on a monthly basis, the researchers found that 91.4% of all cases were correctly managed. In addition, 12 children with severe pneumonia, who were referred, would have been missed without the use of Rad-G pulse oximetry.

The researchers concluded, “The pulse oximeter implementation was found to integrate well within a primary healthcare level. The robustness and ease of usability of the device is perhaps the biggest advantage observed, which has led to some of the states budgeting for PO [pulse oximetry] for scale-up in all the districts. A rigorous evaluation in scaled up facilities should be considered by the government. The implementation tentatively demonstrates that a systematic approach to diagnosing pneumonia is likely to improve case management.”

The authors also noted, “Considering the importance of hypoxemia and fast breathing as a sign of severe illness, an ideal pulse oximeter is one which functions as a point-of-care device, is durable, affordable, easy to maintain and can deliver rapid, reliable noninvasive SpO₂ measurements. A device that measures respiratory rate should also be considered for wider usage given the difficulty among healthcare workers [of] measur[ing] respiratory rate manually. Improving case management of pneumonia at the primary care level by expanding ARI diagnostic aids, while also increasing coverage of IMNCI, strengthening referral pathways, and improving quality of care in referral facilities, will contribute majorly to the SDG [Sustainable Development Goal] goal of reducing under-5 mortality.”

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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.³ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁴ improve CCHD screening in newborns,⁵ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^6-9 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹⁰ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2021-22 U.S. News and World Report Best Hospitals Honor Roll.¹¹ 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. Kumar H, Sarin E, Saboth P, Jaiswal A, Chaudhary N, Mohanty J, Bisht N, Tomar S, Gupta A, Panda R, Patel R, Kumar A, Gupta S, Alwadhi V. Experiences from an Implementation Model of ARI Diagnostic Device in Pneumonia Case Management Among Under-5 Children in Peripheral Healthcare Centers in India. Clin Med Insights: Pediatrics. 2021;(15)1-10. DOI: 10.1177/11795565211056649.
2. Alwadhi V, Sarin E, Kumar P, Saboth P, Khera A, Gupta S, Kumar H. Measuring accuracy of plethysmography based respiratory rate measurement using pulse oximeter at a tertiary hospital in India. Pneumonia. 2020. 12:4.. https://doi.org/10.1186/s41479-020-00067-2
3. 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.
4. 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.
5. 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.
6. 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.
7. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
8. 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.
9. 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.
10. Estimate: Masimo data on file.
11. 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 Rad-G^®. 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 Rad-G, 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.

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