Masimo landed FDA clearance to introduce its O3 regional oximetry technology in the United States. O3 uses near-infrared spectroscopy to measure intracerebral regional tissue oxygen saturation (rSO2), and is intended for use only with adults above 88 lbs (50 Kg). The technology should assist clinical staff in detecting regional hypoxemia that commonly used pulse oximetry (SpO2) is unable to spot.
O3 regional oMasimo O3 Regional Oximetry System to Detect Hypoxemia in Brain FDA Clearedximetry is a module that can be used along with Masimo’s Root patient monitor, which will display both rSO2 and SpO2, as well as the difference between the two. One can also setup a baseline and an on-screen readout will display how far the patient moves away from the preset. Moreover, the system calculates the area under the curve that is an indicator of how long and deep the patient has been poorly oxygenated.
From Masimo’s announcement:
In a study on 27 subjects published in Anesthesia and Analgesia in 2014, Dr. Daniel Redford of the University of Arizona compared cerebral oxygen saturation measurements obtained from O3 with saturations obtained from blood samples (SavO2) through induced hypoxia. O3 regional oximetry provided absolute root-mean-squared error of 4% and relative rootMasimo O3 Regional Oximetry System to Detect Hypoxemia in Brain FDA Cleared-mean-squared error of 2.1%.1 This study did not require that end tidal carbon dioxide (EtCO2) levels be fixed in the study protocol, allowing the rSO2 measurement to be responsive to changes in tissue oxygen saturation due to changes in CO2 in the blood. Follow up studies with O3 extended the subject pool to 74 subjects and demonstrated that O3 maintained its absolute and relative accuracy.
Product page: O3 Regional Oximetry…
Via: Masimo…