In New Clinical Study Masimo’s Oxygen Reserve Index Helps Clinicians Detect Impending Desaturation in Pediatric Patients
4.2.2016 13:03 | Business Wire
Masimo (NASDAQ: MASI) announced today that in a new clinical study, Masimo’s Oxygen Reserve Index (ORI™), the first noninvasive and continuous parameter to provide insight into patients’ oxygen reserve when they are receiving supplemental oxygen, helped clinicians in the early identification of impending desaturation in pediatric patients during induction of anesthesia.1
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Masimo Root® with ORI™ (Photo: Business Wire)
Oxygen saturation (SpO2) using pulse oximetry provides noninvasive, continuous visibility to arterial blood oxygenation in hypoxia (lower than normal oxygenation) and normoxia (normal oxygenation). For procedures such as induction of anesthesia and intubation, clinicians will usually build an “oxygen reserve” in the patient by providing supplemental oxygen or “pre-oxygenation,” creating a transitional state of hyperoxia (higher than normal oxygenation). The extent of hyperoxia can be determined by the measured partial pressure of oxygen in the blood (PaO2), which requires invasive arterial blood sampling and laboratory analysis. When patients have low oxygen reserve prior to intubation of the trachea, they are susceptible to sudden hypoxia, depending upon the time taken to perform the intubation.
ORI, Masimo’s 11th rainbow® parameter2, is a relative index of the partial pressure of oxygen in arterial blood (PaO2) within the range of 100 to 200 mmHg that can provide insight into significant changes in oxygen reserve. ORI is intended to supplement, not replace, SpO2 monitoring and PaO2 measurements.
In a prospective study published in Anesthesiology and conducted at Children’s Medical Center in Dallas, Texas, Dr. Peter Szmuk and colleagues evaluated whether ORI could provide a clinically important warning of impending desaturation in pediatric patients with induced apnea after pre-oxygenation. The investigators enrolled 33 patients in this study. Eight of these resumed spontaneous ventilation during the study period, leaving 25 apneic patients to evaluate, with an average age of 7.6 years. Data were recorded continuously by the Masimo Radical-7® Pulse CO-Oximeter®, connected to the patient through an R1 25L rainbow® sensor. ORI was retrospectively calculated and was not visible to investigators.
After pre-oxygenation with supplemental oxygen, anesthesia induction, and endotracheal intubation, the anesthesia circuit was disconnected and SpO2 was allowed to decrease to 90% before ventilation recommenced. During the period of apnea, the ORI progressively decreased from a mean of 0.73±0.2 at the beginning of apnea to 0.37±0.1. The SpO2 remained at 100% during this initial period. After decreases in ORI that would trigger the ORI alarm if monitored in real time, there was a median elapsed time of 31.5 seconds before the SpO2 decreased to 98%. After reinstitution of ventilation, SpO2 values declined further to 88%, before recovering to 98%, 34 seconds later. The researchers concluded that “In this pilot study, we found that during prolonged apnea in healthy anesthetized children, the ORI detected impending desaturation in median of 31.5 seconds (IQR, 19 to 34.3 seconds) before noticeable changes in SpO2 occurred. Knowing even roughly how much time remains before the rapid desaturation phase begins seems likely to guide proper decisions.”
Radical-7® with Root® has a CE Mark with the ORI parameter. ORI is not FDA cleared and is not available for sale in the United States.
@MasimoInnovates | #Masimo
1. Szmuk P, Steiner JW, Olomu, PN, Ploski, RP, Sessler, DI, Ezri, T. Oxygen Reserve Index A Novel Noninvasive Measure of Oxygen Reserve—A Pilot Study. Anesthesiology 2016; 124:00-00. doi:10.1097/ALN.0000000000001009.
2. 11 parameters include: 1) Oxygen saturation (SpO2); 2) Pulse rate; 3) Perfusion index (PI); 4) Pleth Variability Index (PVI®); 5) Respiration Rate from the pleth (RRp®); 6) Total hemoglobin (SpHb®); 7) Oxygen Content (SpOC™); 8) Carboxyhemoglobin (SpCO®); 9) Methemoglobin (SpMet®); 10) Fractional oxygen saturation (SpfO2®); 11) Oxygen Reserve Index (ORI™)
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. The benefits of Masimo SET® have been proven in more than 100 independent and objective studies and it is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. 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®), and more recently, Pleth Variability Index (PVI®) and Oxygen Reserve Index (ORI™), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root®, an intuitive open architecture patient monitoring and connectivity platform designed to speed the pace of innovation and reduce the cost of care. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com.
This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo’s Oxygen Reserve Index (ORI™). These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including ORI™, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions with comparable accuracy and unique advantages, including immediate and continuous results that enable earlier treatment without causing invasive trauma in all patients and in every clinical situation; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.
Irene Paigah, 858-859-7001
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