Study investigates feasibility and accuracy of CCHD screening with new Masimo iSpO2

Masimo announced today 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). iSpO₂ Rx is a smart device-paired pulse oximeter featuring Masimo Measure-through Motion and Low Perfusion™ pulse oximetry technology.

CCHD affects approximately 2.5 to 3 newborns per 1000 live births and requires intervention soon after birth to prevent significant morbidity or mortality; later detection in infants also increases the risk of brain damage. 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% ± standard deviation of 1.76%, with limits of agreement of -3.52% and 3.36%. For postductal SpO₂ values, they calculated a mean bias of -0.11% ± standard deviation of 1.68%, with limits of agreement of -3.41% and 3.18%.

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%. 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% ± standard deviation of 1.74%, with limits of agreement of -3.42% and 3.43%.

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