What's The Difference? Clinical Studies

Helping to Monitor Vulnerable Patients

From the very beginning, infants and children have been the focus of our research development with solutions designed exclusively for vulnerable patients.

Enabling Newborn Screening

Some 10-30% of babies who die from congenital heart disease do not have their condition diagnosed before
autopsy.1 Researchers have found that Masimo SET® pulse oximetry may reliably assist clinicians in the screening for critical congenital heart disease (CCHD), when combined with standard screening protocols, spurring the US Secretary of Health and Human Services to add pulse oximetry to the recommended Uniform Screening Panel for newborns.1-3 Masimo SET® pulse oximeters and sensors meet the recommended criteria for newborn screening, were exclusively used in the two studies that were the basis for the CCHD workgroup decision to recommend newborn screening, and were the first to receive FDA 510(k) clearance with labeling for CCHD screening.3

CCHD Screening with Physical Examination Alone and Physical Examination with Masimo SET®

In a study of newborns, researchers found critical congenital heart disease (CCHD) was identified by physical examination alone 63% of the time, and when Masimo SET® pulse oximetry was added to the physical exam screening, researchers showed that clinicians were able to identify CCHD 83% of the time–a 31% increase.1

N = 39,821 babies Physical Exam Alone Physical Exam + Masimo SET® Pulse Oximetry Screening2
Sensitivity for CCHD Detection 63% 83%
Specificity for CCHD 98% 99.8%

SpO2 screening was conducted on 39,821 newborn babies, preductally (palm of right hand) and postductally (either foot) before routine physical examination. The baby was considered to be screening positive if: 1) either preductal or postductal SpO2 measurement was <90%; 2) if in three repeat measurements, both preductal and postductal SpO2 were <95%, or the difference between the two measurements was >3%.

Helping Clinicians Manage Retinopathy of Prematurity

Premature infants requiring neonatal intensive care need enough oxygen to preserve vital organ function, but too much oxygen can cause severe eye damage from retinopathy of prematurity (ROP).4

Researchers Found that Masimo SET®, in Combination with Clinical Practice, Led to a Reduction in Severe ROP4

Center Incidence of ROP III-IV and Laser Treatment when using Nellcor N-395 or Masimo SET® Pulse Oximetry
Period 1 (pre-policy change) Period 2 (post-policy change) Period 3 (post-policy change)
A 12% with Nellcor 5% with Masimo 4% with Masimo
B 13% with Nellcor 13% with Nellcor 6% with Masimo

In period one, the baseline rate for severe ROP in two centers, both using Nellcor pulse oximetry, is established. In period two, the oxygen targeting policies, caregivers, and patient characteristics were the same at both centers, but only Center A switched to Masimo SET®, which led to a significant reduction in ROP (from 12% to 5%). In period three, Center B switched to Masimo SET® and experienced a reduction in ROP from period two (from 13% to 6%).

Monitoring Cyanotic Patients

Masimo Blue® Sensors are indicated to monitor neonates, infants and pediatric patients with congenital cyanotic cardiac lesions. In cyanotic infants, researchers found that Masimo SET® with the Blue Sensor enabled maintenance of targeted oxygen saturation levels.5 And for very low birth weight babies, the Masimo NeoPt-500 sensors are designed for both size and performance in infants as small as 500 grams.

Newborn Monitoring and Assessment

When each second matters during newborn resuscitation, the Masimo Newborn Sensor ensures fast response time at a high sensitivity–allowing clinicians to focus on real-time patient management.

Researches have found Improved outcomes for Rapid Response Team Activations and ICU transfers on the Medical Surgical Units with Masimo Patient SafetyNet™*

In August 2012, The Joint Commission Sentinel Event Alert on the safe use of opioids in hospitals recommended implementation of better dosing and continuous oxygenation and ventilation monitoring (instead of spot checks) in post-surgical patients.6 Patient SafetyNet–combined with Masimo SET® pulse oximetry and rainbow Acoustic Monitoring® or standard capnography–offers a clinically proven, cost-effective approach to continuous post-operative monitoring with high nursing satisfaction and patient compliance.

Designed to Improve Patient Safety and Quality of Care

For many years, clinicians have understood the risks of not continuously monitoring patients on the medical-surgical units. In a study published in Anesthesiology, researchers found the following results; After implementing Masimo SET® and Patient SafetyNet remote monitoring and wireless notification system in a post-surgical floor where only intermittent spot-checking was used before:

  • > 65% Reduction in Rapid Response Team Activations7**
  • > 48% Reduction in ICU Transfers7
  • > An Average of Four Alarms Per Patient Per Day7

In another article published in the Anesthesia Patient Safety Foundation Newsletter, researchers found:

  • > Zero Preventable Deaths or Brain Damage Due to Opioids8†
  • > $1.48 Million in Cost Savings8

Studies Showed Improvements in the Process of Care

"The number of ABG's obtained and the time to wean to a low FiO2 was nearly half.
This change in practice reduces the costs of oxygen supply and delivery and the associated
risk of morbidity from excessive oxygen exposure."

Charles G. Durbin
Prof.of Anesthesiology, University of Virginia

Researchers have shown that the use of Masimo SET® technology may lead to potential annual savings in critical care environment.
Reduction in Adhesive Sensor Use9,10
49% - 56%
Reduction in Arterial Blood Gas Analysis11
Reduction in O2 Requirements11,12
40% - 49%
Reduction in Length of Stay12
Reduction in False Alarms13


To learn how Masimo may help your institution lower its costs while improving patient care call

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.

ISA AX+ and ISA OR+ are not licensed for sale in Canada.