We have always kept neonatal patients close to our hearts. With Project Stork and the development of SET® Measure-through Motion and Low Perfusion™ pulse oximetry, Masimo solved seemingly unsolvable problems and made a significant impact on neonatal care, helping clinicians reduce the incidence of retinopathy of prematurity (ROP) and improve critical congenital heart disease (CCHD) screening.
Today, Masimo remains dedicated to helping clinicians improve neonatal care through a variety of innovative clinical solutions.
Masimo’s breakthrough technology, Signal Extraction Technology® (SET®), overcame the limitations of conventional pulse oximetry with the ability to measure through motion and low perfusion. Masimo SET® is able to recognize that both arterial and venous blood can move, using parallel signal processing engines to separate the true arterial signal from sources of noise, including the venous signal. Multiple studies have demonstrated that Masimo SET® outperforms conventional pulse oximetry technologies.1 In one study comparing the ability of three pulse oximetry technologies to detect hypoxic events, Masimo SET® pulse oximetry demonstrated the highest sensitivity and specificity during induced conditions of motion and low perfusion.2
Masimo SET® had 3% missed true alarms and 5% false alarms versus 43% and 28%, respectively, using competitor technology.
Results shown are calculated by combining sensitivity and specificity outcomes of machine-generated and volunteer-generated motion.
At Masimo, innovation never stops. After these studies were published, Masimo achieved significant accuracy specification improvements for RD SET sensors, improving from 3% ARMS to 1.5% ARMS* in conditions of motion.
Premature infants in neonatal intensive care units are routinely administered supplemental oxygen to help preserve vital organ function. However, too much oxygen administration, which can lead to hyperoxia, can increase the risk of severe eye damage from retinopathy of prematurity (ROP).3 Clinicians use pulse oximetry to help manage the administration of oxygen, but unreliable pulse oximetry measurements can result in over administration of oxygen and subsequent ROP.
In two NICU settings, Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, coupled with changes in clinical practice, showed significantly reduced rates of severe retinopathy of prematurity (ROP) and decreased the need for laser therapy.4,5
In a study of 571 inborn infants (<1250 g), a change in clinical practice combined with the use of Masimo SET® pulse oximetry led to significant reductions in severe ROP and need for laser therapy.4
In another study, following the implementation of Masimo SET® with a new protocol in a single tertiary neonatal center at Cedars-Sinai Medical Center (CSMC), the incidence of severe ROP decreased over a five-year period from 12.5% to 2.5% in very low birth weight infants.5
Methemoglobinemia is a blood disorder characterized by an abnormal amount of methemoglobin—a form of hemoglobin unable to effectively bind to oxygen—in the blood. Many drugs commonly used in hospitals—such as lidocaine, benzocaine, dapsone, and nitrates—may cause a dangerous reaction known as acquired methemoglobinemia.6 Inhaled nitric oxide (iNO) therapy, and even topical anesthetics containing benzocaine or prilocaine, can cause elevated levels of methemoglobin in neonates and infants.7.8
Masimo Pulse CO-Oximetry provides a method of noninvasively and continuously monitoring methemoglobin, SpMet®. Real-time SpMet monitoring may help clinicians intervene quickly and appropriately in cases involving elevated methemoglobin levels.9
Masimo provides multiple sensor options to address the challenging needs and specific requirements of neonatal patients, including SofTouch sensors with little-to-no adhesive, which allow for gentle application on the skin of fragile newborn and pre-term babies, and the NeoPt-500, a non-adhesive sensor made specifically for newborns weighing 1 kg or less.
The Masimo® RD SET® Blue sensor is indicated for single-patient use for the continuous noninvasive monitoring of arterial oxygen saturation (SpO2) and pulse rate for neonates, infants, and pediatric patients with congenital cyanotic cardiac lesions in hospitals, hospital type facilities, and mobile and home environments.
When used with Masimo rainbow SET® Pulse CO-Oximeters®, rainbow® sensors provide noninvasive and continuous oxygen saturation (SpO2) and methemoglobin (SpMet) measurements.
O3 Regional Oximetry uses near-infrared spectroscopy (NIRS) to enable monitoring of tissue oxygen saturation (rSO2) for cerebral and somatic monitoring sites.
Masimo offers a portfolio of sidestream capnography solutions to meet the challenges of ventilation monitoring in the NICU. Sidestream CO2 monitoring works with a full family of NomoLine® sampling lines, airway adapter sets, and cannulas for use in a variety of clinical scenarios, including intubated and non-intubated patients in both low and high humidity applications. NomoLine technology is designed for low-flow applications, with a very low sampling rate of 50 ml/min, supporting use on patients with low tidal volumes and high breath rates, common characteristics of neonatal patients. Masimo capnography seamlessly integrates with Masimo SET® pulse oximetry and other key physiologic parameters, providing clinicians with greater visibility to a patient’s oxygenation, ventilation, and respiratory status.
Masimo. Clinical Evidence. https://www.masimo.com/evidence/featured-studies/feature/.
Shah et al. J Clin Anesth. 2012;24(5):385-91.
Saugstad et al. Journal of Perinatal Medicine. May 2006.
Castillo et al. Prevention of retinopathy of prematurity in preterm infants through changes in clinical practice and SpO2 Technology. Acta Paediatr. 2011;100(2):188-92.
Chow et al. Can changes in clinical practice decrease the incidence of sever retinopathy of prematurity in very low birth weight infants? Pediatrics. 2003;111(2):339-345.
Ash-Bernal R et al. Medicine (Baltimore). 2004;83(5):265-73.
Riou Y et al. Pediatric Research. 1998;43:295.
U.S. Food & Drug, Consumer Updates, Benzocaine and Babies: Not a Good Mix.
Annabi EH et al. Anesth Analg. 2009;108(3):898-9.
Yu Y et al. J Biomed Res. 2016;30(1):1-4.
Greenberg SB et al. J Crit Care. 2013;28(3):270-6.
*ARMS accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within ± ARMS of the reference measurements in a controlled study.
The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.
SpMet monitoring is not intended to replace laboratory blood testing. Blood samples should be analyzed by laboratory instruments prior to clinical decision making.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician. See instructions for use for full prescribing information, including indications, contraindications, warnings, and precautions.
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