Neonatal Intensive Care Unit (NICU)

 

Focusing on the Most Vulnerable Patients

From the beginning, we have kept neonatal patients close to our hearts, and Masimo remains dedicated to improving their care through industry-leading solutions designed to ensure that even the youngest patients have bright futures.

Masimo SET® Measure-through Motion and Low Perfusion™ Pulse Oximetry

 

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 Additionally, in another 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.3

Performance During Motion and Low Perfusion2

Masimo - Performance During Motion and Low Perfusion

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.

After these studies were published, the RD SET® accuracy specifications were improved from 3% ARMS to 1.5% ARMS.*

Reducing Retinopathy of Prematurity (ROP)

 

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

Severe Retinopathy of Prematurity Rate5

Masimo - Severe Retinopathy of Prematurity Rate Graph

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

Rates of Retinopathy of Prematurity in Very Low Birth Weight Infants5

Masimo - Rates of Retinopathy of Prematurity in Very Low Birth Weight Infants chart

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

Acquired Methemoglobinemia

 

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

Sensors Designed for Neonatal Patients

 

O3® Regional Oximetry

 
Masimo - Baby with O3 Regional Oximetry sensor on forehead

The O3 Regional Oximetry platform has been expanded to allow monitoring of infant and neonatal patients for cerebral and somatic monitoring sites.

  • O3 helps clinicians monitor cerebral oxygenation in situations in which peripheral pulse oximetry alone may not be fully indicative of the oxygen in the brain10
  • Monitors cerebral and non-cerebral regions of interest10,11
  • O3 integrates with Masimo SET® pulse oximetry on Root®, providing clinicians with expanded visibility of a patient’s oxygenation status11
  • May detect hypoxic threats in tissue under the sensor—delivering critical information to inform effective treatment decisions12,13
  • With its reduced size and flexible design, the O3 neonatal sensor easily conforms to and allows for ergonomic application on small foreheads11

Capnography Solutions

 

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.

Measurements

 

Products

 

References:

  1. 1.

    Masimo. Clinical Evidence. https://www.masimo.com/evidence/featured-studies/feature/.

  2. 2.

    Shah et al. J Clin Anesth. 2012;24(5):385-91.

  3. 3.

    Saugstad et al. Journal of Perinatal Medicine. May 2006.

  4. 4.

    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.

  5. 5.

    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.

  6. 6.

    Ash-Bernal R et al. Medicine (Baltimore). 2004;83(5):265-73.

  7. 7.

    Riou Y et al. Pediatric Research. 1998;43:295.

  8. 8.

    U.S. Food & Drug, Consumer Updates, Benzocaine and Babies: Not a Good Mix.

  9. 9.

    Annabi EH et al. Anesth Analg. 2009;108(3):898-9.

  10. 10.

    Yu Y et al. J Biomed Res. 2016;30(1):1-4.

  11. 11.

    Greenberg SB et al. J Crit Care. 2013;28(3):270-6.

  12. 12.

    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.

  13. *SpO2 accuracy specifications have improved from 3% to 1.5% ARMS in conditions of motion. 

RESOURCES

 

Masimo - Product Information Masimo SET

Product Information

Masimo - Brochure, RD SET Sensors

Brochure

Masimo - Product Information - Neonatal & Infant Care Solutions

Product Information

Masimo - Product Information Product Information

Product Information

Masimo - Blue Sensor Product Information

Product Information

Masimo - Brochure RRa

Brochure

Masimo - Brochure, NomoLine Capnography Sampling Lines

Brochure

Masimo - Brochure, Masimo Automation Platform

Brochure                                                                                                       

Rad-97 with NomoLine capnography is not licensed for sale in Canada.

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.

PLCO-004077/PLM-11086C-0820