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Clinical Study Highlights
Continuous Noninvasive Measurement of Hemoglobin via Pulse CO-Oximetry(1),a clinical study led by Dr. Mark Macknet at Loma Linda University in LomaLinda, California, presented a study that compared an engineering prototype ofMasimo Rainbow SET noninvasive total hemoglobin (SpHb) to invasive laboratoryhemoglobin measurements in two groups. Group one included 55 patientsscheduled to undergo surgery, while group two consisted of 32 healthyvolunteers undergoing a hemodilution protocol. After reviewing 1,538 datapairs, researchers found that the Masimo technology accurately delivered totalhemoglobin levels, with the study showing accuracy of 1.28 mg/dl and0.94 mg/dl for group two, respectively, when compared to invasive laboratoryCO-Oximetry. Researchers concluded that Masimo's device is the "first devicedeveloped that can continuously and noninvasively measure hemoglobinconcentration, in addition to the other common hemoglobin species, andtherefore provides a significant expansion of existing physiologic monitoringtechnology."
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Casual Screening of Hemoglobin Noninvasively Positively Affects aColleague's Future(2), a case report by Dr. Martin Allard at Loma LindaUniversity recounted the application of SpHb to assess an anemic hemoglobinlevel of 10.6 g/dl on a fellow anesthesiologist who otherwise appearedhealthy. Invasive hemoglobin testing confirmed the measurement and furtherdiagnostic testing revealed previously undiagnosed and asymptomatic esophagealcancer. Researchers concluded that Masimo SpHb allowed the "detection of thispotentially devastating tumor before clinical signs or symptoms becameapparent, which resulted in early intervention and therapy that may well becurative for this colleague."
New Pulse Oximetry Sensors with Low Saturation Accuracy Claims(3),performed by Dr. Peter Cox at the Hospital for Sick Children in Toronto,Canada, evaluated 12 patients with congenital cyanotic cardiac lesions (CCCL)to compare noninvasive oxyhemoglobin (SpO2) measurements from the MasimoRainbow SET Radical 7 device with Blue Sensor and the Covidien N-600 device(OxiMax with Lo-Sat) to invasive oxyhemoglobin levels from laboratoryCO-Oximetry. Although the Nellcor N-600 with LoSat is advertised to work inCCCL patients, the accuracy demonstrated in this study was 6.49%, well outsideof Nellcor's published specifications. In contrast, the Masimo Radical withBlue Sensor, the first and only sensor with accuracy claims cleared forcyanotic patients, performed within Masimo specifications and hadsignificantly better accuracy at 3.85%. Study results demonstrate that theMasimo Blue sensor, which was "designed for use specifically in this patientpopulation, is more accurate." Dr. Peter Cox, Hospital for Sick Children inToronto, Canada, said, "Accurate monitoring of oxygen saturations in childrenwith cyanotic congenital heart defects is essential for appropriate patientmanagement and, therefore, its impact on their long-term outcome. The MasimoBlue Sensor accurately tracks saturation to levels as low as 60%, which willgreatly assist caregivers in the management of this patient population."
Severe Methemoglobinemia Detected by Pulse CO-Oximetry in the OperatingRoom(4), a case report by Dr. Steven J. Barker and Dr. E. H. Annabi at
