Masimo today announced the results of a randomized, prospective, double-blind, controlled trial published in the Journal of the College of Physicians and Surgeons Pakistan . In this study, Dr. Sukriye Akdag and his team from Marmara University in Istanbul assessed the impact of continuous, non-invasive hemoglobin monitoring with Masimo SpHb on the management of blood transfusions in adult patients undergoing major elective surgery, where blood loss of at least 20% is expected. The researchers found that the post-operative transfusion rate of erythrocytes was lower, and the hemoglobin level of patients in intensive care was higher, when monitoring in the operating room was carried out with SpHb. Their conclusion was that “SpHb contributes to effective blood management in major surgery. » 1The researchers noted that unnecessary or late blood transfusions were associated with higher mortality and morbidity. They therefore sought to assess the impact of continuous hemoglobin monitoring with Masimo SpHb, which tracks the trend of hemoglobin levels, non-invasively and in real time. The researchers included 120 patients aged 18 to 85 (ASA score: I-III) undergoing major surgery, and randomized them into two groups: the SpHb group (n=60) and a control group (n=60 ). No significant differences were found in demographics or mean blood pressure, heart rate, or blood gases between the two groups. In the control group, the patients' hemoglobin was measured by the classic technique of intermittent blood sampling analyzed using an ABL800Flex radiometer at the start of the procedure, during the second hour, during the fourth time and at the end of the intervention. In the SpHb group, ) and Transfusion Index (Pi) with Masimo Radical-7  Pulse CO-Oximeters  . In the event of a sudden drop in the hemoglobin level, an additional blood gas analysis was carried out. In both groups, a transfusion was performed when the hemoglobin level measured in the blood gases fell below 9 g/dL (in accordance with the recommendations of the European Society of Anaesthesiology).

After post-operative comparison of all the measurements, the researchers observed that there was no significant difference between the groups with regard to hemoglobin, platelet or creatinine levels; no difference either in the quantities of fresh frozen plasma or suspension of platelets transfused during and after the intervention, nor in the quantities of erythrocyte units transfused during the intervention. However, the postoperative erythrocyte transfusion rate in the SpHb group was significantly lower (SpHb group: median 0 international units (IU); control group: median 2 IU; p=0.020).* postoperative hemoglobin in patients in the SpHb ICU group was also higher,

The investigators concluded that “In major surgical procedures, SpHb measurement can complement conventional Hb measurement methods for effective blood management. […] Insofar as this approach can decrease mortality and morbidity by reducing postoperative blood transfusion, the use of such an advanced monitoring method in the event of major surgery can increase patient safety. »

This study adds to the growing body of literature demonstrating the value of continuous hemoglobin monitoring with SpHb. The SpHb system, used in patient blood management, has been shown to improve outcomes for both high and low blood loss surgeries, such as reducing the percentage of patients receiving transfusions allogeneic, 2.3 the number of erythrocyte units transfused per patient, 4-6 the transfusion time, 7 the costs, 8 and even the mortality 30 and 90 days after surgery of 33% and 29% respectively (in association with a goal-oriented filling algorithm thanks to Masimo PVi ). 9 This demonstration of the impact of SpHb on results covers the entire world, representing today 7 countries on 4 continents. 1-9 Today, Masimo SpHb technology is used by clinicians and healthcare facilities in more than 75 countries.

The SpHb system is not intended to replace laboratory blood testing. Clinical decisions regarding erythrocyte transfusions should be made by the clinician based on his or her assessment, which should take into account, among other factors, the patient's condition, ongoing SpHb monitoring, and diagnostic laboratory tests performed on blood samples.

*Transfusion rate data were provided by the authors after publication of the study and are included here with their permission.

@Masimo | #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide range of industry-leading monitoring technologies, including meters, sensors, patient monitors, and automation and connectivity solutions innovative. Additionally, Masimo Consumer Audio is home to eight legendary brands of audio equipment, including Bowers & Wilkins, Denon, Marantz and Polk Audio. Our mission is to improve the quality of life and therapeutic results of patients, and to reduce the cost of care. In 1995, the company introduced pulse oximetry, Masimo SET  Measure-through Motion and Low Perfusion, which has been shown to outperform other pulse oximetry technologies in more than 100 independent, objective studies.Masimo SET  has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates, 11 improve detection of critical congenital heart disease in neonates, 12 and, when used in the continuous monitoring with Masimo's Patient SafetyNet in post-surgery rooms, reducing the number of calls to rapid response teams and transfers to intensive care units, as well as the associated costs. 13-16 Masimo SET  is estimated to be used by more than 200 million patients in hospitals and major healthcare facilities worldwide, 17and that it is the primary pulse oximetry device in 9 of the 10 largest hospitals listed in the US News and World Report Best Hospitals Honor Roll of 2022-2023. 18 In 2005, Masimo introduced rainbow  Pulse CO-Oximetry technology for noninvasive, continuous monitoring of blood components that previously could only be measured by invasive procedures, including total hemoglobin (SpHb  ), oxygen content (SpOC), carboxyhemoglobin (SpCO  ), methemoglobin (SpMet  ), plethysmographic variability index (PV  ), RPVi (rainbow PVi), and oxygen reserve index (ORi). In 2013, Masimo launched the Root  patient monitoring and connectivity platform , designed to be as flexible and scalable as possible to make it easy to add other Masimo and third-party monitoring technologies; key Masimo additions are Next Generation  brain function monitoring, O3  regional oximetry and ISA capnography with NomoLine  sample lines . The Pulse CO-Oximeters range of devicesContinuous and spot monitoring from Masimo includes devices designed for use in a variety of clinical and non-clinical situations, including tetherless wearable technology such as Radius-7  , Radius PPG  and Radius VSM, wearable devices such as Rad- 67  , fingertip pulse oximeters such as MightySat  Rx, and devices for hospital and home use such as Rad-97  . Masimo's hospital and home care automation and connectivity solutions are built around the Masimo Hospital Automation platform and include Iris Gateway  , iSirona, Patient SafetyNet, Replica , Halo ION  , UniView  , UniView:60 and Masimo SafetyNet  . The company's growing portfolio of health and wellness solutions includes Radius Tº  and the Masimo W1™ watch. To learn more about Masimo and its products, visit www.masimo.com . Published clinical trials of Masimo products are available at www.masimo.com/evidence/featured-studies/feature/ .

ORi, RPVi and Radius VSM have not obtained 510(k) clearance from the FDA and are not for sale in the United States. The Patient SafetyNet trademark is used under license from University HealthSystem Consortium.

References

1. Akdag S, Zengin SU, Cakmak G, Umuroglu T, Aykac ZZ, Saracoglu A. Targeted Bleeding Management Guided by Non-Invasive Haemoglobin Measurement in Surgical Patients. J Coll Physicians Surg Pak 2022; 32(10):1242-1248.
2. Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
3. Nakamori E et al. Geriatr Orthop Surg Rehabil. 2021 Nov 19;12:21514593211060575.
4. 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.
5. Merolle L, Marraccini C, Di Bartolomeo E, Montella M, Pertinhez T, Baricchi R, Bonini A. Postoperative patient blood management: transfusion appropriateness in cancer patients. Blood Transfus 2020; 18: 359-65 DOI 10.2450/2020.0048-20.
6. Saracoglu A, Abdullayez R, Sakar M, Sacak B, Incekoy F, Aykac Z. Continuous hemoglobin measurement during frontal advancement operations can improve patient outcomes. J Clin Mon Comp. 7 Mar 2022. https://doi.org/10.1007/s10877-022-00813-5.
7. Kamal AM et al. The Value of Continuous Noninvasive Hemoglobin Monitoring in Intraoperative Blood Transfusion Practice During Abdominal Cancer Surgery. Open J Anesth. 2016;13-19.
8. Ribed-Sánchez B et al. Economic Analysis of the Reduction of Blood Transfusions during Surgical Procedures While Continuous Hemoglobin Monitoring is Used. Sensors. 2018, 18, 1367; doi:10.3390/s18051367.
9. Cros J et al. Continuous hemoglobin and plethysmography variability index monitoring can modify blood transfusion practice and is associated with lower mortality. J Clin Monit Comp. 3 Aug 2019. https://doi.org/10.1007/s10877-019-00367-z.
10. Published clinical trials on pulse oximetry and the benefits of Masimo SET  can be viewed on our website at http://www.masimo.com . Comparative studies include independent and objective studies, consisting of abstracts presented at scientific meetings, and peer-reviewed journal articles.
11. 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.
12. 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.
13. Taenzer A 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.
14. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter . Spring-Summer 2012.
15. McGrath S 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.
16. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.
17. Estimate: Masimo internal data.
18. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

Forward-looking statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Such statements statements include, but are not limited to, statements regarding the potential effectiveness of Masimo SpHb  , Masimo PVi  and Masimo Radical-7  Pulse CO-Oximeters . 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 often beyond our control, and could cause actual results to differ materially and adversely. from those expressed in our forward-looking statements in response to various risk factors, including, without limitation: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's novel noninvasive measurement technologies, including Masimo SpHb, Masimo PVi and Masimo Radical-7 Pulse CO-Oximeters, contribute to positive clinical outcomes and patient safety; the risks related to the potential lack of precision of the results and conclusions of the researchers; risks related to our belief that Masimo's noninvasive medical advances offer cost-effective solutions and unmatched benefits; risks related to the COVID-19 epidemic; as well as other factors detailed in the "Risk Factors" section of our most recent reports filed with the United States Securities and Exchange Commission ("SEC"), available free of charge on the the SEC atwww.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether these expectations will prove to be correct. All forward-looking statements contained in this press release are expressly qualified in their entirety by the preceding cautionary statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We undertake no obligation to update, modify or clarify these statements or the "Risk Factors" section in our most recent reports filed with the SEC, whether in response to new information, future events or for any other reason, except as required by applicable securities laws.

The text of the press release resulting from a translation should in no way be considered official. The only authentic version of the press release is that of the press release in its original language. The translation will always have to be compared with the source text, which will set a precedent.

Contacts
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com

 

Source:businesswire.com

 

 

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