Masimo Announces Recent Study Monitoring Methemoglobin Levels During Administration of Inhaled Nitric Oxide
Red blood cells containing hemoglobin can become oxidized in the
presence of certain drugs and compounds, including nitric oxide,
changing it to methemoglobin (MetHb), which impairs the oxygen-carrying
capacity of blood. When MetHb levels rise, headache, respiratory
distress, cyanosis, and finally death may occur. A 2004 study conducted
An estimated 1.2 million people die from malaria annually worldwide,
with a mortality rate of 8-20% in children with severe malaria.3
In the Ugandan study, Dr.
The investigators in
The researchers stated that “we were able to evaluate the variability in MetHb responses within subjects and the frequency of methemoglobinemia prompting study gas discontinuation. Despite the high doses of iNO administered, study gas was temporarily discontinued only five times for MetHb >10% (all children in the iNO group). We were able to re-start study gas for all children that had a MHb measurement that exceeded 10% once the MetHb returned to <7 % without having the MetHb exceed 10% again. It was not necessary to wean children off iNO, in contrast to studies administering iNO to neonates with hypoxic respiratory failure, as we did not observe any rebound effects (e.g. worsening oxygenation) following discontinuation of study gas.”
The authors concluded that, “Hospitalized children with evidence of impaired oxygen delivery, metabolic acidosis, anemia, or malaria were at risk of methemoglobinemia. However, we demonstrated high-dose iNO could be safely administered to critically ill children with severe malaria with appropriate MHb monitoring.”
SpMet monitoring is not intended to be used as the sole basis for making diagnosis or treatment decisions. It is intended to be used in conjunction with other clinical tools, including signs and symptoms and laboratory blood tests.
@MasimoInnovates | #Masimo
- Conroy et al. Methemoglobin and nitric oxide therapy in Ugandan children hospitalized for febrile illness: results from a prospective cohort study and randomized double-blind placebo-controlled trial. BMC Pediatrics. (2016) 16:177. DOI 10.1186/s12887-016-0719-2.
Ash-Bernal et al. Acquired methemoglobinemia: A retrospective series
of 138 cases at 2 teaching hospitals. Medicine.
October 2004;83(5)265-73. DOI 10.1097/01.md.000141096.00377.3f.
- Murray et al. Global malaria mortality between 1980 and 2010: a systematic analysis. Lancet. 2012;379(9814):413-31.
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to helps clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and more recently, Pleth Variability Index (PVi®) and Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (PI). Studies with SpHb have shown reductions in unnecessary blood transfusion*,6,7 and when used with PVi, reductions in length of hospital stay8 and 30- and 90-day mortality.9 In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.
*Clinical decisions regarding red blood cell transfusions should be based on the clinician’s judgment considering, among other factors: patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.
- Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
- de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338.
- Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
- Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
McGrath SP et al. Surveillance Monitoring Management for General Care
Units: Strategy, Design, and Implementation.
The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
- Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedia Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
Awada WN et al. Continuous and noninvasive hemoglobin monitoring
reduces red blood cell transfusion during neurosurgery: a prospective
cohort study. J
Clin Monit Comput. 2015 Feb 4.
- Thiele RH et al. Standardization of Care: Impact of an Enhanced Recovery Protocol on Length of Stay, Complications, and Direct Costs after Colorectal Surgery. JACS (2015). doi: 10.1016/j.jamcollsurg.2014.12.042.
Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring.
Proceedings from the 2016 ASA Annual Meeting,
Chicago. Abstract #A1103.
This press release includes forward-looking statements as defined in
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934, in connection with the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements include, among others, statements regarding the potential
effectiveness of Masimo SpMet®. These forward-looking
statements are based on current expectations about future events
affecting us and are subject to risks and uncertainties, all of which
are difficult to predict and many of which are beyond our control and
could cause our actual results to differ materially and adversely from
those expressed in our forward-looking statements as a result of various
risk factors, including, but not limited to: risks related to our
assumptions regarding the repeatability of clinical results; risks
related to our belief that Masimo's unique noninvasive measurement
technologies, including Masimo SpMet, contribute to positive clinical
outcomes and patient safety; as well as other factors discussed in the
"Risk Factors" section of our most recent reports filed with the