Masimo (NASDAQ: MASI) today announced the findings of a prospective, single-blinded, randomized controlled study published in theJournal of Anesthesia & Intensive Care Medicine in which Dr. Mona Mohamed Mogahed and colleagues at Tanta University in Tanta, Egypt and The King Fahd General Hospital in Jeddah, Saudi Arabia, sought to evaluate the impact of varying ventilation strategies on the cerebral oxygenation of patients undergoing video-assisted thoracoscopic surgery (VATS).
To monitor the variety of physiological parameters needed to undertake such an evaluation, they turned to the multi-modal Masimo Root patient monitoring and connectivity platform, which is designed to allow clinicians to streamline their ability to keep track of numerous modalities, simultaneously, using a single, intuitive monitor. The technologies involved included O3 regional oximetry, capnography with NomoLine sampling lines, SedLine brain function monitoring, and multiple rainbow Pulse CO-Oximetry measurements. Using Root and Masimo monitoring technologies, the researchers were able to determine that maintaining higher end-tidal carbon dioxide (EtCO2) improved baseline regional cerebral oxygenation (rSO2), with impacts on early postoperative cognitive function that included improvements in Aldrete scores and mini mental status exam (MMSE) scores.
Noting the increased risk of hypoxemia during one-lung ventilation (OLV) as part of VATS, which can lead to postoperative neurocognitive dysfunctions, the authors hypothesized that increasing EtCO2 could be a 'convenient and powerful' way to manage cerebral desaturation during the surgery. They enrolled 70 patients, ages 18-65, undergoing elective VATS requiring OLV, between September 2021 and September 2022 at The King Fahd General Hospital, Jeddah. All patients were operated on by the same surgical team. The patients were randomly divided into two groups: in the first, EtCO2 was maintained at 32-38 mmHg (group I) and in the second, at 39-45 mmHg (group II). During the procedure, monitored parameters included oxygen saturation (Masimo SET SpO2), heart rate (HR), and noninvasive hemoglobin (Masimo SpHb) via an RD rainbow SET fingertip sensor; EtCO2 via capnometer and NomoLine sampling line; noninvasive blood pressure (NIBP), body temperature, and rSO2 via O3 near-infrared spectroscopy (NIRS) sensors monitoring both brain hemispheres and Masimo Patient State Index (PSi), a processed EEG parameter used to help clinicians maintain appropriate sedation, via SedLine. Outcomes included Aldrete scores and MMSE scores assessed at 3 and 24 hours after surgery.
The researchers found that the percentage of change in rSO2 differed significantly between groups (p < 0.05), on both sides of the brain, with the higher values, over time, in Group II, in direct relation with the higher EtCO2 maintained in that group. In the right hemisphere, the difference became significant at the fourth time interval [T4] at which rSO2 was recorded, p = 0.0012, and maintained significance for the remainder of surgery [T4-T13], p < 0.001. In the left hemisphere, the difference became significant at T2, p = 0.09, and remained significant [T3-13], p < 0.001. Aldrete scores were significantly higher in Group II upon arrival at the post-anesthesia care unit (PACU) (p = 0.013) and 15 minutes after arrival (p = 0.03), then became comparable. MMSE scores were significantly higher in Group II 3 hours after surgery (p = 0.0009), but not at 24 hours after surgery.
The researchers concluded, 'Adjusting the ventilator parameters to develop EtCO2 of 39-45 mmHg improved cerebral oxygenation more than EtCO2 of 32-38 mmHg, that play[s] a protective role in the brain, causing significant impact on the early postoperative cognitive function in patients with OLV undergoing VATS.' Regarding the use of Masimo Root and associated monitoring technologies, they noted that they 'preferred using it as it can display several clinical measurements [at] the same time, such as HR, BP, temperature, SpO2, EtCO2, PSi, and rSO2.'
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. In addition, Masimo Consumer Audio is home to eight legendary audio brands, including Bowers & Wilkins, Denon, Marantz, and Polk Audio. Our mission is to improve life, 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.5-8 Masimo SET is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,9 and is the primary pulse oximetry at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.10 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, Radius PPG, and Radius VSM, 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 and home automation and connectivity solutions are centered around the Masimo Hospital Automation platform, and include Iris Gateway, iSirona, Patient SafetyNet, Replica, Halo ION, UniView, UniView :60, and Masimo SafetyNet. Its growing portfolio of health and wellness solutions includes Radius T and the Masimo W1 watch. 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, RPVi, and Radius VSM 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.
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 Root, O3, NomoLine, SedLine, rainbow, RD rainbow SET, SpHb, SET, and PSi. 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 Root, O3, NomoLine, SedLine, rainbow, RD rainbow SET, SpHb, SET, and PSi, contribute to positive clinical outcomes and patient safety; risks that the researchers' conclusions and findings may be inaccurate; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; 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:
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Tel: 949-396-3376
Email: elamb@masimo.com
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