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New Study Affirms Masimo rainbow® Pulse CO-Oximetry™ Accuracy for Noninvasive Carboxyhemoglobin and Methemoglobin Measurements

Date Announced: 09 Jul 2012

Suggests potential use of spectral screening for carbon monoxide poisoning in emergency room.

IRVINE, Calif., July 9, 2012 /PRNewswire/ -- Masimo (MASI) announced today a new study in Respiratory Physiology & Neurobiology shows that noninvasive carboxyhemoglobin (SpCO®) and methemoglobin (SpMet®) measurements with Masimo rainbow® Pulse CO-Oximetry™ are accurate and conclude they can be used as an effective first screening test with emergency room patients suspected of suffering carbon monoxide (CO) poisoning.(1)

CO poisoning is a major cause of morbidity and mortality(2) and is responsible for more than 50,000 emergency department visits per year in the United States.(3) Because symptoms of CO poisoning are nonspecific – ranging from mild headache, nausea, confusion, and dizziness to end-organ injury, such as myocardial infarction, stroke, and death – diagnosis is difficult and has historically relied on clinical suspicion and confirmation by measurement of carboxyhemoglobin (COHb) via invasive blood-gas analysis. Unfortunately, it has been estimated that up to half of U.S. hospitals do not have invasive COHb testing ability – increasing the potential that many victims of CO poisoning could be overlooked and misdiagnosed.(4)

The study was conducted on healthy subjects who inhaled a mixture that included carbon monoxide such that it raised the COHb to 10% to 14%. Investigators compared the mean bias and precision of SpCO and SpMet data obtained noninvasively with a Masimo Rad-57™ Pulse CO-Oximeter and adult reusable SpCO rainbow® sensor (DCI-dc3) with invasive venous blood samples analyzed on an arterial blood-gas analyzer (ABL80 FLEX CO-oximeter, Radiometer America).

The SpMet results showed the mean bias was 0.0% and precision was 0.3%. The SpCO measurements showed a mean bias of –0.8% and precision of 2.5%.

Researchers noted the Rad-57 "provides coherent and reproducible day-to-day measurement" of SpCO and SpMet, and concluded the "Rad-57 should be used as a first screening to determine whether an invasive blood measurement of COHb should be performed to confirm the (CO) intoxication."

(1) Zaouter C, Zavorsky G. "The measurement of carboxyhemoglobin and methemoglobin using a noninvasive pulse CO-oximeter." Respiratory Physiology & Neurobiology 2012 (http://dx.doi.org/10.1016/j.resp.2012.05.010)

(2) Suner S, Patridge R, Sucov A, et al. "Noninvasive pulse CO-oximetry screening in the emergency department identifies occult carbon monoxide toxicity." J Emerg Med. 2008; 34(4):441-50.

(3) Weaver LK. "Carbon monoxide poisoning." N Engl J Med. 2009; 360(12):1217-1225.

(4) Hampson NB, Scott KL, Zmaeff JL. Carboxyhemoglobin measurement by hospitals: Implications for the diagnosis of carbon monoxide poisoning. J Emerg Med 2006;31(1):13-6.

Source: Masimo Corp.

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