New Study Recommends the Use of Masimo PVi® to Guide Fluid Administration During Major Oncosurgery with Lung Ultrasonography


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IRVINE, Calif .-- (BUSINESS WIRE) - Masimo (NASDAQ: MASI) today announced the results of a summary presented at ANESTHESIOLOGY 2021 in San Diego in which Drs. Anita Kulkarni and Arti Dalal of the Rajiv Gandhi Cancer Institute in New Delhi, India, investigated the use of non-invasive, continuous Masimo PVi® as part of targeted fluid therapy (GDFT) to control intraoperative hydration during major oncosurgery, where lung ultrasound (LUS) is used to diagnose extravascular lung water (EVLW) used. The researchers found that using PVi as a dynamic, continuous method of managing hydration resulted in patients receiving less fluids and fewer B-lines (a measure of EVLW), with no post-operative perfusion or oxygenation compared Too significantly decreased using a central venous pressure (CVP) -controlled protocol for fluid administration. 1

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

Since conventional invasive methods of fluid management (such as CVP) during major oncosurgery can increase EVLW, which can lead to postoperative cardiorespiratory complications, the authors investigated whether the use of a non-invasive, dynamic, continuous method - GDFT under Masimo PVi could improve the Fluid management by reducing the amount of fluid administered and the B-lines measured by LUS. To evaluate PVi, they compared two groups of adult patients undergoing major oncooperation with LUS: a group of 60 patients whose hydration was controlled by PVi as part of GDFT and a group of 59 patients whose hydration was controlled by CVP was controlled. Her primary endpoint was evidence of EVLW as indicated by the total number of B-lines, and her secondary endpoint was adequacy of blood flow based on lactate levels at the end of surgery. The authors also measured arterial blood gas samples at baseline and at the end of surgery to assess oxygenation.

When comparing the amount of fluid administered, the researchers found that the PVi group (1875.8 ± 593.9 ml) compared to the CVP group (2132.6 ± 504.5 ml; p = 0.012) had significantly fewer total crystalloids as well significantly fewer colloids were administered in the bolus (PVi group: 584 ± 358.5 ml; CVP group: 778.2 ± 242.2 ml; p = 0.001). They found that 23.3% of patients in the PVi group had “mild” B-lines and 5.0% had “moderate” B-lines, compared with 44.1% mild and 5.1% moderate in patients of the CVP group (p = 0.042). At the end of the operation, they found a statistically significant decrease in the CVP group (p

The authors concluded: “We recommend pulmonary ultrasonography after major oncosurgical interventions to detect EVLW and intraoperative PVi-controlled GDFT, as these patients received less fluid, had fewer B-lines (light) and no decrease in PaO2 or PaO2 / FiO2 Values ​​at [the] End of the operation. "

In the United States, PVi is approved as a non-invasive, dynamic indicator of fluid reactivity in selected populations of mechanically ventilated adult patients.

@Masimo | #Masimo

About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and manufactures a wide range 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 care costs. Masimo SET® Measure-through Motion and Low Perfusion ™ Pulse Oximetry, introduced in 1995, has shown in over 100 independent and objective studies to outperform other pulse oximetry technologies. Premature neonatal3 improves CCHD screening in neonates4 and reduces CCHD screening when used for continuous monitoring Masimo Patient SafetyNet ™ in post-operative wards, enabling rapid response teams, ICU transfers, and costs.5-8 Masimo SET® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare facilities around the world9 and is the primary pulse oximetry in 9 of the top 10 hospitals listed in the US News and World Report Best Hospitals Honor Roll 2021-22 .10 Masimo continues to refine SET® and announced in 2018 that the SpO2 accuracy of the RD SET® sensors under movement conditions has been considerably improved, which doctors still do the SpO2 values ​​on which you rely, accurately reflect the physiological status of a patient, gives more certainty. In 2005, Masimo introduced the rainbow® Pulse CO-Oximetry technology, which enables non-invasive and continuous monitoring of blood components that could previously 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, which is from the ground up as flexible and extensible as possible to make it easy to add other Masimo and third-party monitoring technologies; Key additions to Masimo include next-generation SedLine® brain function monitoring, O3® regional oximetry and ISA ™ capnography with NomoLine® sampling lines. Masimo's family of continuous and random monitoring Pulse CO-Oximeters® includes devices designed for use in a variety of clinical and non-clinical scenarios, including wireless, wearable technology such as Radius-7® and Radius PPG ™, portable devices such as the Rad-67®, fingertip pulse oximeters such as the MightySat® Rx, and devices available in both hospital and home environments such as the Rad-97®. Masimo hospital automation and connectivity solutions are based on the Masimo Hospital Automation ™ platform and include Iris® Gateway, iSirona ™, Patient SafetyNet, Replica ™, Halo ION ™, UniView®, UniView: 60 ™ and Masimo SafetyNet ™. More information about Masimo and its products can 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 in the United States. The Patient SafetyNet brand is used under license from the University HealthSystem Consortium.

References

  1. Kulkarni A, Dalal A. Lung ultrasound for the diagnosis of extravascular lung water in large oncooperations. Presented at ANESTHESIOLOGY 2021, San Diego, California, October 9, 2021. Abstract # A1067.
  2. For published clinical studies on pulse oximetry and the benefits of Masimo SET®, please visit 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.
  3. Castillo A et al. Preventing premature retinopathy in preterm infants through changes in clinical practice and SpO2 technology. Acta Pediatr. 2011 Feb; 100 (2): 188-92.
  4. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of gait-dependent congenital heart defects: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009; January 8; 338.
  5. Taenzer A et al. Impact of Pulse Oximetry Monitoring on Rescue Events and Intensive Care Transfers: A Before and After Competitive Study. Anesthesiology. 2010: 112 (2): 282-287.
  6. Taenzer A et al. Postoperative Monitoring - The Dartmouth Experience. Newsletter of the Anesthesia Patient Safety Foundation. Spring-Summer 2012.
  7. McGrathS et al. Surveillance Monitoring Management for General Care Units: Strategy, Design and Implementation. The Journal of the Joint Commission on Quality and Patient Safety. 2016 Jul; 42 (7): 293-302.
  8. McGrathS et al. Inpatient respiratory arrest associated with sedative and analgesic drugs: effects of continuous monitoring on patient mortality and severe morbidity. J patient safety. 2020 March 14th DOI: 10.1097 / PTS.0000000000000696.
  9. Estimate: Masimo data in file.
  10. 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 and Section 21E of the Securities Exchange Act of 1934 in conjunction with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others: other, statements regarding the potential effectiveness of PVi® and the new study that recommends the use of PVi (the “Study”). These forward-looking statements are based on current expectations about future events that affect 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 that are expressed in our forward-looking statements as the result of various risk factors including, but not limited to: risks associated with our assumptions about the repeatability of clinical results; Risks related to our belief that Masimo's unique non-invasive measurement technologies, including PVi, contribute to positive clinical outcomes and patient safety; Risks that the researchers' conclusions and recommendations based on the study may not be correct; Risks related to our belief that Masimo's non-invasive medical breakthroughs offer cost-effective solutions and unique benefits; Risks related to COVID-19; and other factors discussed in the "Risk Factors" section of our latest filings with the Securities and Exchange Commission ("SEC"), which are available free of charge on the SEC's website at www.sec.gov. While we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove to be correct. All forward-looking statements contained in this press release are expressly restricted in their entirety by the preceding cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak as of today only. We undertake no obligation to update, add to, or clarify these statements or the "Risk Factors" in our most recent filings with the SEC, whether as a result of new information, future events, or otherwise, unless otherwise under applicable law Securities laws.

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

Source: Masimo


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