New Study Investigates the Ability of Masimo ORi to Provide Early Warning of Hypoxemia During Endotracheal Intubation in ICU Patients - Seite 2

The researchers concluded, “The median time between the ORi decrease below 0.4 and the SpO₂ decrease below 97% during the apneic period was 81 seconds [34–146]. A higher ORi during preoxygenation was independently associated with a lower risk of mild hypoxemia (SpO₂ < 97%).”

The researchers noted that the median 81 seconds of forewarning “may allow immediate intubation, early face-mask ventilation, insertion of a supraglottic device, or a call for help in the event of intubation difficulties.” In addition, they noted that “ORi monitoring can help identify patients who do not increase their oxygen reserve despite preoxygenation and are therefore at [increased] risk of desaturation during ETI. These patients may benefit from a longer preoxygenation period and/or a change in device.” The authors further noted that “an ORi decline might lead to the detection of a fault in the preoxygenation technique such as an insufficient oxygen flow rate or major leaks.”

As a study limitation, the authors noted that their findings cannot be generalized to ICU patients who did not meet the inclusion criteria, as those patient cohorts remain to be evaluated. The inclusion criteria for this study were ICU admission with a need for ETI and an SpO₂/FiO₂ ratio above 214. The SpO₂/FiO₂ ratio was measured during noninvasive ventilation or high-flow oxygen therapy; for conventional oxygen therapy, the fraction of inspired oxygen (FiO₂) was calculated as FiO₂ = 0.21 + O₂ [rate in L/min] x 0.03.

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

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About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is to improve patient outcomes, reduce the cost of care, and take noninvasive monitoring to new sites and applications. Masimo SET Measure-through Motion and Low Perfusion pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.² Masimo SET has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,³ improve CCHD screening in newborns,⁴ and, when used for continuous monitoring with Masimo Patient SafetyNet in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^5-8 Masimo SET is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁹ and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2021-22 U.S. News and World Report Best Hospitals Honor Roll.¹⁰ Masimo continues to refine SET and in 2018, announced that SpO₂ accuracy on RD SET sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO₂ values they rely on accurately reflect a patient’s physiological status. 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), RPVi (rainbow PVi), and Oxygen Reserve Index (ORi). In 2013, Masimo introduced the Root Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine Brain Function Monitoring, O3 Regional Oximetry, and ISA Capnography with NomoLine sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7 and Radius PPG, portable devices like Rad-67, fingertip pulse oximeters like MightySat Rx, and devices available for use both in the hospital and at home, such as Rad-97. Masimo hospital automation and connectivity solutions are centered around the Masimo Hospital Automation platform, and include Iris Gateway, iSirona, Patient SafetyNet, Replica, Halo ION, UniView, UniView :60, and Masimo SafetyNet. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.