Study Evaluates Performance of Masimo iSpO2 Rx Smart Device-Paired Pulse Oximeter

Masimo has announced the findings of a recently published study in which researchers in Maastricht, The Netherlands, evaluated the performance of Masimo iSpO₂ Rx in screening newborns for critical congenital heart disease (CCHD).¹ iSpO₂ Rx is a smart device-paired pulse oximeter featuring Masimo Measure-through Motion and Low Perfusion pulse oximetry technology.
 
CCHD affects approximately two and a half to three newborns per 1,000 live births² and requires intervention soon after birth to prevent significant morbidity or mortality; later detection in infants also increases the risk of brain damage.³ In the study, Dr. Huizing and colleagues sought to evaluate the accuracy of iSpO₂ Rx because of increasing trends toward out-of-hospital births and concerns about the costs of CCHD screening implementation in low-resource settings. The researchers surmised that a portable, low-cost pulse oximeter may be more practical in such settings than standalone hospital devices.
 
The researchers enrolled 201 infants in the study. CCHD screening was conducted 12-24 hours after birth by two independent teams, who were blinded to the other team’s results. Each team took both preductal (right-hand) and postductal (either foot) SpO₂ measurements to establish whether an infant passed, failed, or needed a repeat screening. One team measured oxygen saturation using a Masimo Radical-7 Pulse CO-Oximeter equipped with disposable Masimo LNCS sensors. The other team used a Masimo iSpO₂ Rx equipped with a reusable M-LNCS YI sensor, connected to an Apple iPad Mini.
 
Applying Bland-Altman analysis to the preductal SpO₂ values of the 201 screened infants, with Radical-7 as the reference device, the researchers calculated a mean bias of -0.08 percent ± standard deviation of 1.76 percent, with limits of agreement of -3.52 percent and 3.36 percent. For postductal SpO₂ values, they calculated a mean bias of -0.11 percent ± standard deviation of 1.68 percent, with limits of agreement of -3.41 percent and 3.18 percent.
 
In addition, to evaluate the ability of iSpO₂ Rx to measure low oxygen saturation, the researchers also enrolled a group of 12 infants admitted to the neonatal intensive care unit (NICU) with SpO₂ lower than 95 percent. SpO₂ was continuously monitored for 10 minutes, with readings recorded once per minute, and with one foot connected to the iSpO₂ Rx and the other to a Philips IntelliVue MP70 monitor equipped with Masimo SET technology. Using the Philips monitor as the reference device, the researchers calculated a mean bias of 0.01 percent ± standard deviation of 1.74 percent, with limits of agreement of -3.42 percent and 3.43 percent.
 
The researchers concluded that, “Our data suggest that CCHD screening with the Masimo iSpO₂ Rx is feasible and accurate. The use of reliable smartphone-paired pulse oximeters may contribute to the extension of CCHD screening to home births and low resource settings.” They also noted that, “The iSpO₂ Rx demonstrated a high degree of agreement with the Masimo Radical-7, a hospital-grade pulse oximeter.”
 
The device used in this study is iSpO₂ Rx. The study did not use the iSpO₂, which is intended as an exercise and wellness product and is not available for use on neonates. iSpO₂ is not intended for CCHD screening or any other medical use. iSpO₂ Rx does not have U.S. Food and Drug Administration 510(k) clearance and is not available for sale in the United States.
 
References
1. Huizing M, Villamor-Martinez-E, Chavagne I, Vanagt W, Spaanderman M, and Villamor E. Reliability and Validity of a Smartphone-Paired Pulse Oximeter for Screening of Critical Congenital Heart Defects in Newborns. Neonatology. 2017;112:324–329. DOI: 10.1159/000477294.
2. Hoffman JL et al. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-1900.
3. 2011 Legislative Report; State of Maryland, Department of Health and Mental Hygience, State Advisory Council on Hereditary and Congenital Disorders. Recommendations on Implementation of Screening for Critical Congenital Heart Disease in Newborns. Page 7.
 
Masimo develops noninvasive monitoring technologies. 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 16 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 role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO₂ pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter.
 
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References
1. 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.
2. 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;338.
3. 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.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. 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.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.