New Study Investigates the Utility of Home Monitoring Using Masimo SET® Pulse Oximetry to Screen Children with Down Syndrome for Risk of Obstructive Sleep Apnea Prior to Diagnostic Multichannel Sleep Studies
Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers investigated whether home pulse oximetry monitoring might be a useful initial screening method of determining which children with Down syndrome (DS) – who are at high risk of obstructive sleep apnea (OSA) – be recommended to undergo multichannel sleep studies to diagnose the condition. The home monitoring was conducted using Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry.1
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180813005147/en/
Masimo Radical-7® Pulse CO-Oximeter® (Photo: Business Wire)
Noting that OSA “can only be reliably diagnosed using multichannel sleep studies, which are expensive, demanding for families and only available in specialist centres,” Dr. Hill and colleagues at the University of Southampton and Southampton Children’s Hospital sought to determine whether home pulse oximetry monitoring could identify children at high risk of OSA, and in particular which parameters could most sensitively detect this risk, as an initial screening step. To that end, they studied 161 children with DS, aged 0.5 to 6 years, of whom 25 were separately diagnosed with OSA. The patients were monitored overnight using Masimo Radical-7® Pulse CO-Oximeters®, with pulse oximetry sensors placed on the great toe. Recorded measurements included: total artifact-free time analyzed, mean oxygen saturation (SpO2), minimum SpO2, 3% oxyhemoglobin desaturation index (ODI), delta 12s index (the absolute difference between successive 12 second interval recordings, a measure of baseline SpO2 variability) and the number of minutes per hour that SpO2 was below 90%.
Receiver operating curves (ROC) and area under the curve (AUC) statistics were calculated to determine which measurements, alone and in combination, best predicted OSA status. During data analysis, researchers were blinded to which children had separately received a diagnosis of OSA. The researchers found that “the greatest AUC was achieved by the delta 12s index. At a threshold of >0.555, this identified 23/25 (sensitivity 92%) OSA cases and 89/136 true negatives (specificity 65%). The same sensitivity was achieved for 3% ODI with marginally lower specificity of 63% (86/136 true negatives).” The combined model (delta 12s index, 3% ODI, mean and minimum SpO2) detected all true positives (100% sensitivity) but with lower specificity (53%). This result would lead 60% of the sample population (12 true positives and 18 false negatives) to confirmatory multichannel studies.
The researchers concluded that “universal screening for OSA in children with DS using simple pulse oximetry parameters could halve the number of children requiring specialist multichannel studies. Pulse oximetry is widely available, well tolerated, readily acquired in the home and its adoption could reduce the burden on health services and families alike.”
The researchers noted that “our findings specifically apply to parameters generated by Masimo oximeters and cannot be generalised to other devices. Masimo technology extracts motion artefact, this is important in children with DS who are restless sleepers.” They also noted that “the use of a retrospective clinical dataset, with anonymous data shared for this analysis, limits our information on the wider sampling frame, demographic and clinical characteristics of these children.”
Masimo pulse oximetry is not cleared in the United States to screen children with Down syndrome for risk of obstructive sleep apnea.
@MasimoInnovates | #Masimo
- Hill C, Elphick H, Farquhar M, Gringras P, Pickering R, Kingshott R, Martin J, Reynolds J, Joyce A, Gavlak J, and Evans H. Home oximetry to screen for obstructive sleep apnoea in Down syndrome. Arch Dis Child. doi:10.1136/archdischild-2017-314409.
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. 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. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 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®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect® (MOC-9®) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7® wearable patient monitor, iSpO2 ® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at http://www.masimo.com/evidence/featured-studies/feature/.
ORi has not received FDA 510(k) clearance and is not available for sale in the United States.
The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.
- 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.
- 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.
- 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.
- Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
- 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.
- Estimate: Masimo data on file.
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 SET® 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 SET® and Radical-7, 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.
Evan Lamb, 949-396-3376
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
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
San Fang Chemical Switches to Rimini Street Support for its Oracle EBS and Oracle Database Software22.8.2019 22:00:00 CEST | Press release
Rimini Street, Inc. (Nasdaq: RMNI), a global provider of enterprise software products and services, the leading third-party support provider for Oracle and SAP software products and a Salesforce partner, today announced that San Fang Chemical Co., Ltd., a global manufacturer and distributor of artificial leather products headquartered in Taiwan, has switched to Rimini Street support for its Oracle E-Business Suite application and Oracle Database software. In addition to immediately saving 50% of its annual maintenance costs that they were previously paying the vendor, the company can now maintain its core, robust Oracle system for a minimum of 15 years from the time that they switched to Rimini Street support with no forced upgrades. San Fang Chemical has also been able to liberate its IT resources and divert its substantial cost savings to invest in more forward-looking innovation projects to help pave the way for future growth and competitive advantage. This press release features mu
Gravity Unveils its Future Plans During Gamescom 201922.8.2019 15:46:00 CEST | Press release
Gravity Interactive, Inc., a subsidiary of Gravity Co., Ltd. (NASDAQ: GRVY) which is a leading global game company, participated in Gamescom which is one of the three largest game fairs in the world, held in Cologne, Germany from August 20th to 24th. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190822005507/en/ Gravity Interactive, Inc., a subsidiary of Gravity Co., Ltd. (NASDAQ: GRVY) which is a leading global game company, participated in Gamescom which is one of the three largest game fairs in the world, held in Cologne, Germany. At the fair, Gravity announced that it plans to launch ‘Ragnarok M: Eternal Love’ in the European region on September 4th 2019. ‘Ragnarok M: Eternal Love’ will be launched in Russia and Turkey, as well as Europe and it will be serviced in seven languages including English, Portuguese, Spanish, Russian, German, French, and Turkish. (Photo: Business Wire) On August 20th, Gravity held a presentati
RoboSense and Aidrivers Announce a Partnership to Deliver Superior Autonomous Solutions for Industrial Transportation22.8.2019 14:55:00 CEST | Press release
RoboSense, the leading supplier of LiDAR perception system solutions, and Aidrivers, the UK's leading provider of autonomous mobility solutions for industrial applications announced today a partnership in system integration. Aidrivers will integrate RoboSense Smart LiDAR Sensor System into their own Autonomous Driving Systems. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190822005468/en/ RoboSense and Aidrivers announce a partnership to deliver superior autonomous solutions for industrial transportation Aidrivers is delivering a fully autonomous natural navigation system that meets industrial safety standards to seaports, particularly for horizontal transportation, aimed for improving operation efficiency and leading the way in industrial autonomous mobility automation. Their solution can work under all harsh weather conditions by achieving true 3D mapping and localization for precision positioning and situation cognisance
Alight to Acquire NGA Human Resources, One of the Largest Multi-Country Payroll and HR Solutions Providers in the World22.8.2019 14:00:00 CEST | Press release
Alight Solutions, a leader in technology-enabled health, wealth and human capital management (HCM) and financial management solutions, today announced it has signed a definitive agreement to acquire NGA Human Resources, a leading provider of digital HR and multi-country payroll services. The proposed transaction is subject to customary closing conditions. With a nearly 50-year history, NGA HR brings innovation, high-quality service, HR and payroll expertise to its more than 250 clients, representing three million employees. As one of the largest multinational payroll providers, NGA HR is enabled to deliver HR & payroll services across more than 188 countries. Underpinning NGA HR’s HR and payroll expertise is its industry leading technology platforms including hrX, which provides companies with a centralized point to access their payroll and HR solutions including analytics; and its euHReka multi-tenant cloud payroll platform, which is localized to support payroll in 51 different countr
Andersen Global Premieres in Colombia22.8.2019 13:30:00 CEST | Press release
Andersen Global is proud to announce a collaboration agreement with a law firm in Colombia. Bogotá D.C.- based Jiménez, Higuita, Rodríguez & Asociados (JHR Corp.) is the first firm with which Andersen Global has developed a presence in the country. Colombia is the tenth country in Latin America in which Andersen Global has a presence with nearly 900 total professionals in the region. JHR, founded in 2017, employs approximately 50 legal and tax professionals, each with deep legal experience within accounting. JHR provides services to national and foreign companies, both private and public, and specializes in tax, customs, and exchange law. “We are a young firm, but we have a desire to be the very best in Colombia,” said Julián Jiménez Mejía, JHR Office Managing Director. “That drive has enabled us to grow so quickly and double our size in just two years. Our ambitions for our firm continue to increase, and we look forward to broadening our service capabilities and ability to provide sea
Mary Kay Appoints Katherine Weng General Manager for China22.8.2019 13:00:00 CEST | Press release
Mary Kay Inc., a leading corporate advocate of women’s empowerment and entrepreneurship, announced the appointment of Katherine Weng as General Manager for Mary Kay (China) Co., Ltd. Based in Shanghai, Weng will report directly to Mary Kay’s Asia Pacific Region President, KK Chua. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190822005337/en/ Katherine Weng, General Manager for Mary Kay China. (Photo: Mary Kay Inc.) “Katherine’s tireless work ethic, strategic mindset, and ability to forge long-term relationships have enabled Mary Kay China to reach new heights,” says Chua. “She is passionate about our mission to enrich women’s lives. She understands our Independent Beauty Consultants’ needs and works hard to fulfill those needs to support their businesses. Within the company, she has successfully created a seamless link between sales, marketing and operations. We look forward to continued growth in China under her leadershi