New Clinical Study Presented at the International Anesthesia Research Society's Annual Meeting Shows Benefit of Masimo's Oxygen Reserve Index, ORI
Pulse oximetry (SpO2) provides noninvasive and continuous visibility to arterial blood oxygenation in hypoxia and normoxia (normal oxygenation). Clinicians often use arterial oxygen partial pressure (PaO2), which can be intermittent and delayed, to monitor levels of hyperoxia (higher than normal oxygenation). Between invasive sampling, changes in PaO2 can be difficult to assess, and therefore hypoxia or hyperoxia can occur unexpectedly.
In the retrospective study conducted at
Researchers included for analysis 1,540 ORI samples using a Masimo Radical-7® Pulse CO-Oximeter®. Regression analysis was used to compare PaO2 from clinically indicated arterial blood gas samples to ORI and calculated changes in ORI (ΔORI) to calculated changes in PaO2 (ΔPaO2).
During a total of 2,377 monitored hours, researchers found that ORI could be calculated about 91.5% of that time, and indicated that ORI was a noninvasive method for measuring moderate hyperoxia (PaO2 was ≥ 150 mmHg in 96.5% of ORI > 0.54, while PaO2 was > 100 mmHg for all ORI > 0.24).
Investigators noted; "An ORI decrease to near 0.24 may provide early warning of declining PaO2 approaching 100 mmHg," such as during procedures that mandate apnea or one lung ventilation; during difficult intubation; trauma patients with pulmonary contusion or massive resuscitation, and that "the ability to detect PaO2 ≥ 150 mmHg by ORI > 0.54 may prove useful for titrating (fraction of inspired oxygen) FiO2."
Researchers concluded: "For intraoperative PaO2 between 240 and 100 mmHg, decrease in ORI appears to provide a clinically useful indication of falling PaO2 before desaturation," and further stated, "Use of this technology could allow for early detection of impending hypoxia in the critical care setting, particularly in patients with congestive heart failure, which would lead to more rapid treatment and possibly mitigate the need for intubation and mechanical ventilation."
Radical-7® with Root has a CE Mark with the ORI parameter and is not
1. Applegate R, Dorotta I, Applegate P, Andrews G, Olson M, Um M. "Relationship Between Oxygen Reserve Index and Arterial Partial Pressure of Oxygen During Surgery." Proceedings of the
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)
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 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 risks related to our assumptions regarding the repeatability of clinical results, risks related to our assumptions that Masimo ORI offers noninvasive, continuous patient monitoring enabling full-time visibility to dissolved arterial oxygen status that may enable proactive interventions in all patients, as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the