Business Wire

Study Investigates the Ability of Continuous Noninvasive Hemoglobin Monitoring with Masimo SpHb® to Reflect Acute Hemodilution During Incremental Fluid Administration

Share

Masimo (NASDAQ: MASI) announced today that in a study recently published in Anesthesia & Analgesia, researchers evaluated the ability of noninvasive and continuous hemoglobin monitoring with Masimo SpHb® to detect the development of acute hemodilution after graded fluid administration, by comparing it to invasively measured laboratory hemoglobin (BHb), on patients undergoing major surgery.1

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190721005044/en/

Masimo Root® with SpHb® and PVi® (Photo: Business Wire)

Masimo Root® with SpHb® and PVi® (Photo: Business Wire)

In the study, Dr. Şerban Bubenek-Turconi and colleagues at the Carol Davila University of Medicine and Pharmacy and the Prof. C.C. Iliescu Institute for Cardiovascular Diseases in Bucharest, Romania, and Sheba Medical Center in Tel Aviv, Israel, examined the effects of incremental fluid loading (as part of perioperative goal-directed therapy (GDT)) on oxygen delivery and whether noninvasive SpHb monitoring could reliably track the development of acute hemodilution (which can necessitate blood transfusions that might otherwise be avoided). They analyzed data from 40 adult patients undergoing major gastrointestinal or vascular surgery. SpHb was continuously measured using Masimo Root® with the Radical-7® Pulse CO-Oximeter®. BHb and partial pressure of oxygen (PaO2) were intermittently, invasively measured using a Radiometer ABL800 blood gas analyzer. Cardiac output (CO) and stroke volume (SV) were also obtained through invasive modalities. Oxygen delivery (DO2) was calculated as: CO*((Hb*1.38*SpO2)+PaO2*0.0031)). Parameter values were recorded after the induction of general anesthesia and before the start of surgery (T0) and 5 minutes after successive 250 ml colloid fluid challenges (FC) (T1, T2, and T3). Patients were given the second and third fluid challenges if at each stage SV increased by at least 10%. 40 patients received the first FC, 32 received the second, and 20 received the third, for a total of 92 administered FCs.

The researchers found that, “Compared to their baseline values (T0), BHb and SpHb decreased by a mean of 5.3% ± 4.9% and 4.4% ± 5.2%, respectively, after the first FC (T1; n = 40), by 9.7% ± 8.4% and 7.9% ± 6.9% after the second FC (T2; n = 32), and by 14.5% ± 6.2% and 14.6% ± 5.7% after the third FC (T3; n = 20).” Using Bland-Altman analysis of all 132 paired SpHb and BHb values, the researchers found mean bias and precision values of -0.3 ± 1.5 g/dL and limits of agreement of -2.7 to 3.3 g/dL. They also found that concordance rates between changes in SpHb and in BHb after the administration of the 250, 500, and 750 mL of fluid were 83%, 90%, and 100%, respectively. They noted that results showed “excellent” concordance after 750 mL, despite the limited absolute accuracy, which may have been negatively affected by the “well-recognized inherent variability of the laboratory Hb device that served as our reference method.”

The researchers concluded, “In summary, our study shows that acute iatrogenic hemodilution does invariably occur after fluid administration, that it may lead to paradoxical decrease in DO2 especially in ‘nonresponders’ and that its development is made visible by the continuous monitoring of SpHb when >500 mL of colloids are being administered. Further studies are needed to examine the potential clinical benefit of SpHb monitoring in identifying acute hemodilution.”

SpHb is not intended to replace laboratory blood testing. 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.

@MasimoInnovates | #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is to improve patient outcomes and reduce the cost of care. Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.2 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,3 improve CCHD screening in newborns,4 and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.5-7 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,8 and is the primary pulse oximetry at 9 of the top 10 hospitals listed in the 2018-19 U.S. News and World Report Best Hospitals Honor Roll.9 Masimo continues to refine SET® and in 2018, announced that SpO2 accuracy on RD SET™ sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO2 values they rely on accurately reflect a patient’s physiological status. 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®), Pleth Variability Index (PVi®), RPVi™ (rainbow® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine® Brain Function Monitoring, O3® Regional Oximetry, and ISA™ Capnography with NomoLine® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7® and Radius™ PPG, portable devices like Rad-67™, fingertip pulse oximeters like MightySat® Rx, and devices available for use both in the hospital and at home, such as Rad-97™. Masimo hospital automation and connectivity solutions are centered around the Iris® platform, and include Iris Gateway™, Patient SafetyNet, Replica™, Halo ION™, UniView™, and Doctella™. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

  1. Bubenek-Turconi S, Văleanu L, Popescu M, Panaitescu E, Tomescu D, Cacoveanu M, and Perel A. Continuous Noninvasive Hemoglobin Monitoring Reflects the Development of Acute Hemodilution After Consecutive Fluid Challenges. Anesth Analg. 2019. DOI: 10.1213/ANE.0000000000004323.
  2. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
  3. 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.
  4. 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;Jan 8;338.
  5. 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.
  6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
  7. 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.
  8. Estimate: Masimo data on file.
  9. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-Looking Statements

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 SpHb®. 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 SpHb, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Contact information

Media Contact:
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Takeda Recognized in the 2019 Dow Jones Sustainability World Index19.9.2019 08:00:00 EESTPress release

Takeda Pharmaceutical Company Limited (“Takeda”) (TOKYO:4502/NYSE:TAK) today announced that it has been named in the 2019 Dow Jones Sustainability World Index, achieving more than double the average overall industry score. In addition, Takeda was named for the 10th consecutive year in the Dow Jones Sustainability Asia Pacific Index. The Dow Jones Sustainability Indices are an independent indication of the Company’s strong corporate environmental, social and governance (ESG) performance. “Takeda’s commitment to creating and preserving value through environmental, social and governance initiatives is an important part of our role as a patient-centric and values-based global biopharmaceutical leader,” said Christophe Weber, President and CEO. “We understand the significance of sustainable business practices, and we are proud to be recognized for Takeda’s global impact and long-term commitment to building a brighter future.” Takeda achieved more than double the average pharmaceutical indus

INSHUR Strengthens Its Senior Team With the Appointment of Simon Logan From Uber18.9.2019 23:36:00 EESTPress release

INSHUR, the first mobile app to offer Uber drivers insurance in just three minutes, has strengthened its relationship with the ride-sharing app by appointing its former Legal Director of Insurance, EMEA, Simon Logan as VP of Commercial & Legal. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190918005972/en/ Simon Logan - VP Commercial & Legal (Photo: Business Wire) Simon's primary responsibility at Uber was providing legal and commercial counsel throughout the 40 countries Uber is active in the EMEA region. Before this, he was Head of Legal at RSA Insurance Group in London. INSHUR is one of the fastest-growing “insurtechs” and is backed by Munich Re Digital Partners (MRDP). The transatlantic team, based in New York and Brighton, UK, has built a proprietary technology platform to provide insurance to professional drivers globally. INSHUR sold $24M of premium in the first 12 months of operation in 2018 in New York alone and ha

CORRECTING and REPLACING Three Hospital Systems Earn Five-Star Award from Patient Safety Movement Foundation18.9.2019 23:29:00 EESTPress release

In the release dated Sept. 17, 2019, the word "ranking" has been replaced with "award" throughout the release. The corrected release reads: THREE HOSPITAL SYSTEMS EARN FIVE-STAR AWARD FROM PATIENT SAFETY MOVEMENT FOUNDATION Award demonstrates organizations’ commitment to eliminating preventable patient deaths On the first World Patient Safety Day, the Patient Safety Movement Foundation (PSMF) announces that it has awarded Dignity Health, MedStar Health and the UPMC with its five-star award for making commitments in alignment with PSMF’s 18 evidence-based Actionable Patient Safety Solutions (APSS). APSS include solutions designed to help hospitals eliminate preventable patient deaths. Preventable deaths are the third leading cause of death in the U.S. “More than 200,000 patients die from preventable hospital errors in the U.S., and 4.8 million across the globe. Those numbers are simply not acceptable but also unthinkable,” said Dr. David Mayer, PSMF CEO. “Our 5-Star award acknowledges t

IFF to Present at Bernstein Strategic Decisions Conference September 2518.9.2019 23:15:00 EESTPress release

Regulatory News: IFF (NYSE: IFF) (Euronext Paris: IFF) (TASE: IFF), a leading innovator of taste, scent, and nutrition & ingredients today announced that the Company’s management will speak at the Bernstein Strategic Decisions Conference in London on Wednesday, Sept 25, 2019 at 10:30 AM ET. Investors may access the live webcast and accompanying slide presentation on the Company's website at ir.iff.com. For those unable to listen to the live webcast, a recorded version will be made available for replay. Welcome to IFF At IFF (NYSE:IFF) (Euronext Paris: IFF) (TASE: IFF), we’re using Uncommon Sense to create what the world needs. As a collective of unconventional thinkers and creators, we put science and artistry to work to create unique and unexpected scents, tastes, experiences and ingredients for the products our world craves. Learn more at iff.com, Twitter , Facebook, Instagram, and LinkedIn. View source version on businesswire.com: https://www.businesswire.com/news/home/2019091800548

Ceravision Ltd: Ground Breaking Results for New Horticulture Light Technology18.9.2019 19:14:00 EESTPress release

Ceravision Limited, inventor of a new and unique scientific approach to horticulture lighting, today announced the results of trials undertaken over the last six months with a group of leading horticulture businesses. Results from independently conducted trials with Bridge Farm Group on licenced industrial hemp have demonstrated an increase in yield and potency of 40% compared to other lighting solutions. Trials elsewhere on salad crops have also revealed benefits - faster growth, fewer pesticides and less waste. Exploiting its innovative plasma light technology, Ceravision’s new and patented approach to horticultural lighting is based on the ability to produce unique light spectra with unparalleled levels of UV-A and UV-B. This UV spectral range is crucial for indoor cultivation. UV can benefit plants as it enhances the production of the secondary metabolites that act as ‘sunscreens’ and boost aroma, flavonoids, terpenes, colour, nutritional and medicinal values. UV can also improve d

Larger, healthier, more plentiful — Study proves House Wellness Foods’ Feed LP20® improves stock at the cellular level.18.9.2019 18:28:00 EESTPress release

Eons ago, the progress of humankind was thrust forward with the development of farming. Today that progress is challenged simultaneously by climatic and socioeconomic forces, and the future hangs in the balance. Our fundamental need is to nourish the world, and the means to achieve that is increased efficiency in agriculture and aquaculture. To this end, House Wellness Foods has released yet another groundbreaking clinical study showing that its pioneering, immunobiotic-based Feed LP20®, with the primary ingredient, heat-killed Lactobacillus plantarum L-137 (HK L-137), demonstrably increases the farming output, size, and health of genetically-improved farmed tilapia (GIFT), a food with endless potential for feeding diverse populations across the globe. The conclusions of this study could have world-altering impact on the field of aquaculture, and the company will be sharing these at Aquaculture Europe, taking place in Berlin, October 7-10, where one of the study’s directors, Mahmoud A.

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom