May 21, 2013
(NASDAQ: MASI) announced today that a new clinical study posted online in
confirms the clinical utility of Masimo's noninvasive carboxyhemoglobin (SpCO
) from rainbow
Pulse CO-Oximetry™ as a first-line assessment tool in helping clinicians rapidly detect carbon monoxide (CO) poisoning.
CO poisoning accounts for an estimated 50,000 emergency department (ED) visits in the U.S. annually and is the leading cause of accidental poisoning death.
Symptoms of CO poisoning include headache, dizziness, nausea/vomiting, confusion, fatigue, chest pain, shortness of breath, and loss of consciousness, but are often attributed to other illnesses such as the flu. Failure to diagnose CO poisoning can have disastrous consequences for patients and potentially other family members of the affected household.
Unfortunately, only about half (50%) of U.S. acute care hospitals have laboratory CO-oximetry capabilities enabling confirmation of CO poisoning in the blood,
likely due to the expense of the instrumentation. Additional delays occur if a patient needs hyperbaric oxygen therapy, which often requires transfer to yet another medical center with hyperbaric capability.
Previous studies have shown that SpCO can help clinicians increase CO poisoning detection by as much as 39%
and is associated with a shorter time to initiation of treatment (4.4 vs. 5.3 hours) with hyperbaric oxygen.
These data have previously led to suggestions that SpCO could be used as a tool to help determine whether an invasive blood measurement of carboxyhemoglobin (COHb) should be performed to confirm CO intoxication.
Researchers at Departement des urgencies, Centre Hospitalier Regional Universitaire Lapeyronie in Montpellier,
, studied 93 consecutive patients suspected of CO exposure presenting to an urban-based university hospital ED. Patients were tested noninvasively with a
-57™ Pulse CO-Oximeter
, while simultaneous blood samples were taken for laboratory COHb analysis and comparison.
Diagnosis of CO poisoning was determined for 26 (28%) patients. Compared to laboratory COHb values, the bias and standard deviation of SpCO over all patients was -0.2% +/- 3.3%. In six subjects with very high COHb values (greater than 15%), the bias and standard deviation of SpCO was 1.2% +/- 2.2%. The area under the curve for SpCO's ability to detect CO poisoning, which takes into account both sensitivity and specificity, was 0.83 for non-smokers and 0.98 for smokers, with an optimal SpCO threshold of 6% for non-smokers and 9% for smokers.