New studies show Masimo provides unique benefits in pulse oximetry, as well as noninvasive blood constituent and functional hemodynamic monitoring IRVINE, Calif., Oct 25, 2007 /PRNewswire via COMTEX News Network/ -- New studies show Masimo provides unique benefits in pulse oximetry, as well as
noninvasive blood constituent and functional hemodynamic monitoring
IRVINE, Calif., Oct. 25 /PRNewswire-FirstCall/ Masimo, the inventor of
Pulse CO-Oximetry and Read-Through Motion and Low Perfusion pulse oximetry,
reported that multiple independent and objective clinical studies and a case
study were presented last week at the 2007 American Society of Anesthesiology
(ASA) Annual Meeting in San Francisco focused on the unique benefits of
Masimo's noninvasive patient monitoring technologies in helping clinicians
provide improved patient care. These new studies add to the more than 100
independent and objective studies demonstrating the superiority of Masimo SET
pulse oximetry, as well as adding to the growing body of research proving the
efficacy of Masimo Rainbow SET in providing accurate, reliable physiological
measurements of multiple blood constituents that previously required invasive
procedures.
Built on the "gold-standard" of Masimo SET Read-Through Motion and Low
Perfusion technology, Masimo Rainbow SET is the first and only upgradeable
technology platform capable of continuously and noninvasively measuring
carboxyhemoglobin (SpCO), methemoglobin (SpMet) and pleth variability index
(PVI), in addition to oxyhemoglobin (SpO2), perfusion index (PI) and pulse
rate. Highlights of key study findings include:
Masimo SET and Blue Sensor more accurate and more reliable in cyanotic
children
In a study entitled "New Generation and Old Generation Pulse Oximeters in
Children with Cyanotic Congenital Heart Disease" a team of anesthesiologists
headed by Dr. Maxime Cannesson at the Louis Pradel Hospital in Lyon, France,
found that in a study of 10 children ages seven days to 53 months following
palliative cardiac surgery, Masimo obtained readings 100% of the time and
"Nellcor failed to obtain readings 15% of the time." Additionally, findings
showed a "significant difference between the Nellcor SpO2 reading and the
blood gas readings," but no significant difference between the Masimo and
blood gas readings when compared to laboratory CO-Oximetry. For the 116
arterial samples, the accuracy of the Masimo Radical pulse oximeter was two
times better than that of the Nellcor N-395 pulse oximeter, leading
researchers to conclude that "new generation pulse oximeters provide more
accurate information and are more reliable than old generation pulse
oximeters." (1)
A separate study, entitled "New Pulse Oximetry Sensors with Low Saturation
Accuracy Claims -- A Clinical Evaluation" performed by Dr. Peter Cox at the
Hospital for Sick Children in Toronto, Canada, compared the accuracy of the
Masimo Radical with Blue Sensor, the Nellcor N-600 (with Lo-Sat) and Max-I
sensor, and the Radical with LNOP sensor to laboratory CO-Oximetry readings on
12 patients with congenital cyanotic cardiac lesions (CCCL) and concluded that
"despite advances in technology, only the Masimo Blue sensor demonstrates
acceptable accuracy." (2) Findings showed that, although the Nellcor N-600
with LoSat is advertised to work in CCCL patients, the accuracy demonstrated
in this study was not within Nellcor's published accuracy specifications;
whereas the Masimo Radical with Blue Sensor had significantly better accuracy
and was within Masimo specifications.
Masimo Rainbow SET provides a noninvasive tool to greatly facilitate the
clinical diagnosis and treatment for carbon monoxide poisoning and
Benzocaine-induced methemoglobinemia
In a report entitled "Rad-57 Rainbow CO-Oximeter in Detecting
Methemoglobin during Upper GI Endoscopy -- A Case Report" by Dr. Udaya B.
Padakandla at Baylor University Medical Center in Dallas, Texas, the
researcher described how four minutes after the Benzocaine application, the
patient exhibited a rise in methemoglobin levels above 40% along with a
decrease in SpO2 (to 90%), both measured continuously with the Masimo Rainbow
SET Rad-57 and confirmed via arterial blood gas analysis. The patient was
treated for methemoglobinemia with methylene blue and the SpO2 and
methemoglobin levels returned to normal. This case report documents the
induction of methemoglobinemia in a GI patient from Benzocaine spray used as a
topical anesthetic prior to endoscopy and shows the accuracy and effectiveness
of Masimo Rainbow SET to continually and noninvasively measure methemoglobin
levels during the entire procedure as confirmed by blood gas with CO-oximetry.
This case illustrates the importance of continuous monitoring of SpMet when
Benzocaine spray is used. (3)
In another study entitled "Clinical Analyses of 429 Cases of Acute CO
Poisoning," researchers from the Hyperbaric Oxygen Department of Beijing
Chaoyang Hospital in Beijing, China, headed by Dr. Zhou Li, used the Masimo
Rainbow SET Rad-57 Pulse CO-Oximeter and found that 98 of the 429 acute carbon
monoxide (CO) poisoning patients had methemoglobin (MetHb) greater than 1.2
percent at the first measurement with significant positive correlation between
CO and MetHb levels, suggesting that "MetHb may be involved in the
physiopathological process of hypoxia of acute CO poisoning patients." The
application of Masimo Rainbow SET technology in the noninvasive measurement of
carbon monoxide and methemoglobin concentration levels in the blood lead
researchers to conclude that this technology "provides a noninvasive tool to
greatly facilitate the clinical diagnosis and treatment for CO poisoning
patients." (4)
In a study entitled "A Comparison of Finger, Ear and Forehead SpO2 on
Detecting Oxygen Desaturation in Healthy Volunteers," by Dr. Kentaro Tokuda
and researchers from the Kyushu University Hospital in Fukuoka City, Japan,
researchers compared the time for desaturations and resaturations to be
detected by Nellcor forehead (MaxFast), Masimo ear (TC-I) and finger (LNOP)
SpO2 sensors when patients were in heads-down, supine and heads-up positions.
The study found Masimo's ear sensor to be as fast, or slightly faster, than
the Nellcor forehead sensor in detecting desaturations and resaturations. The
researchers concluded "sensors on the head (forehead and ear), especially
Masimo ear sensor, can detect hypoxia as soon as or even sooner than finger,"
adding that "sensors on the head (forehead and ear) can also sense recovery
state from hypoxia sooner than finger." (5)
In addition, a study entitled "New Algorithm for Automatic Estimation of
the Respiratory Variations in the Pulse Oximeter Waveform" conducted at the
Louis Pradel Hospital in Lyon, France by a team headed by Dr. Maxime Cannesson
demonstrated the ability of Pleth Variability Index (PVI) to accurately and
noninvasively detect changes in patient fluid volume. Researchers noted that
PVI "has potential clinical applications for noninvasive hypovolemia detection
and fluid responsiveness monitoring." (6)
About Masimo
Masimo (Nasdaq: MASI) develops innovative monitoring technologies that
significantly improve patient care-helping solve "unsolvable" problems. In
1995, the company debuted Read-Through Motion and Low Perfusion pulse
oximetry, known as Masimo SET, and with it virtually eliminated false alarms
and increased pulse oximetry's ability to detect life-threatening events. More
than 100 independent and objective studies have confirmed that Masimo SET
technology allows clinicians to accurately monitor blood oxygen saturation in
critical care situations. Our Masimo SET platform has significantly addressed
many of the previous technology limitations, has substantially contributed to
improved patient outcomes and has been referred to by several industry sources
as the gold standard in pulse oximetry. In 2005, Masimo introduced Masimo
Rainbow SET Pulse CO-Oximetry, which, for the first time, noninvasively
monitors the level of carbon monoxide and methemoglobin in the blood, allowing
early detection and treatment of potentially life-threatening conditions.
Founded in 1989, Masimo has the mission of "Improving Patient Outcomes and
Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and
Applications." Additional information about Masimo and its products may be
found at http://www.masimo.com.
Masimo, SET, Signal Extraction Technology, Radical, Radical-7, Rad57,
APOD, and Improving Outcomes and Reducing Cost of Care by Taking Noninvasive
Monitoring to New Sites and Applications are registered trademarks of Masimo
Corp. ARM, Acoustic Respiratory Monitoring, BiFi, Rainbow, SpCO, SpMet, SpHb
and Pulse CO-Oximeter are trademarks of Masimo Corp.
(1) New Generation and Old Generation Pulse Oxymeters in Children with
Cyanotic Congenital Heart Disease. Maxime Cannesson, M.D., Jean Neidecker,
M.D., Dominique Bompard, M.D., Catherine Vedrinne, M.D., Ph.D., Jean-Jacques
Lehot, M.D. Anesthesiology, Hospices Civils de Lyon, Louis Pradel Hospital,
Lyon, France.
(2) New Pulse Oximetry Sensors with Low Saturation Accuracy Claims -- A
Clinical Evaluation. Peter N. Cox, M.D., F.R.C.P.C. Department of Critical
Care Medicine, Hospital for Sick Children, Toronto, Ontario, Canada.
(3) Rad-57 Rainbow CO-Oximeter in Detecting Methemoglobin during Upper GI
Endoscopy -- A Case Report. Udaya B. Padakandla, M.B.B.S., F.F.A.R.C.S.I.
Anesthesiology, Baylor University Medical Center, Dallas, Texas.
(4) Clinical Analyses of 429 Cases of Acute CO Poisoning. Zhou Li, M.M.S.,
Chunjin Gao, B.S.M.E., Xiang Huang, M.M.S., Gang Wang, M.D., Huan Ge, B.S.M.E.
Hyperbaric Oxygen Department, Beijing Chaoyang Hospital Affiliate of Capital
University of Medical Sciences, Beijing, China.
(5) A Comparison of Finger, Ear and Forehead SpO2 on Detecting Oxygen
Desaturation in Healthy Volunteers. Kentaro Tokuda, M.D., Kengo Hayamizu,
M.D., Kei Ogawa, M.D., Takeshi Hirai, M.D., Kazuo Irita, M.D., Ph.D.
Anesthesiology and Critical Care Medicine, Kyushu University Hospital, Fukuoka
City, Japan.
(6) New Algorithm for Automatic Estimation of the Respiratory Variations
in the Pulse Oximeter Waveform. Maxime Cannesson, M.D., Bertrand Delannoy,
M.D., Antoine Morand, M.D., Olivier Bastien, M.D., Ph.D., Jean-Jacques Lehot,
M.D., Ph.D. Anesthesiology, Hospices Civils de Lyon, from Louis Pradel
Hospital, Lyon, France.
Contact:
Tom McCall
Masimo Corporation
949-297-7075
SOURCE Masimo
http://www.masimo.com