New Study Evaluates the Ability of Masimo EMMA® Capnography to Assess the Respiratory Status of Children With Tracheostomy

(BUSINESS WIRE)-- Masimo (NASDAQ: MASI) today announced the findings of an observational, retrospective study published in Pediatrics International. In the study, researchers at the Osaka Women’s and Children’s Hospital in Japan found the Masimo EMMA^® Portable Capnograph “useful for assessment of the respiratory condition in children with tracheostomy.”¹ EMMA^® provides seamless mainstream capnography for patients of all ages in a compact, easily portable device. The device requires no routine calibration and minimal warm-up time, with accurate end-tidal carbon dioxide (EtCO₂) and respiration rate measurements and continuous EtCO₂ waveforms displayed within 15 seconds.

Noting the potential value of a compact and portable way to monitor changes in respiratory status for patients in scenarios where typical inpatient hospital monitoring equipment is less likely to be available, Dr. Masashi Hotta and colleagues sought to evaluate the utility of the EMMA capnograph on children with tracheostomy by comparing EtCO₂ values from the EMMA device (which was connected to the distal side of the tracheostomy cannula) to invasively measured partial pressure of venous carbon dioxide (PvCO₂). Although partial pressure of arterial carbon dioxide (PaCO₂) is considered a gold standard for assessing respiratory condition, the researchers chose PvCO₂ because “collection of arterial samples is more invasive than collection of venous samples” and noted that studies have shown a correlation between PaCO₂ and PvCO₂.^2,3 They enrolled 9 infants (median age 8 months) and compared 43 paired EtCO₂-PvCO₂ readings in total.

The researchers found a correlation coefficient of 0.87 (95% confidence interval of 0.7 – 0.93; p < 0.001) between EtCO₂ and PvCO₂ readings. Analysis of the data revealed that EtCO₂ readings were, on average, 10.0 mmHg lower than the corresponding paired PvCO₂ value (95% limits of agreement of 1.0 – 19.1 mmHg). The researchers speculated that the tendency for EtCO₂ to be lower than PvCO₂ may be explained by “gas mixing proximal to the tracheostomy cannula due to the presence of anatomic and physiologic dead space. Because almost all patients used a cannula without a cuff, some air leakage may have occurred. In addition, about two-thirds of the patients had [chronic lung disease or bronchopulmonary dysplasia],” which they noted have been shown to cause lower CO₂ concentrations during exhalation, relative to the partial pressure of CO₂ in the blood.

They also found that the median difference in values was significantly greater for readings collected while patients were on mechanical ventilation (28 of the 43 data pairs). With a ventilator, there was a median 11.2 mmHg (6.8 – 14.3) difference; without a ventilator, there was a median 6.6 mmHg (4.1 – 9.0) difference (p = 0.043). The researchers noted that use of a ventilator was significantly related to the difference in paired readings because patients on ventilators had respiratory or circulatory disease.

Noting that, “We demonstrated a strong positive relationship between PvCO₂ and EtCO₂ and revealed the availability and usefulness of this capnometer for children with tracheostomy,” the researchers concluded, “EMMA is useful for assessment of the respiratory condition in children with tracheostomy. EMMA can be used especially in home-care settings and outpatient departments for such children.” They also noted, “The main strength of this study is that we used a portable capnometer to evaluate EtCO₂.”

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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.⁴ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁵ improve CCHD screening in newborns,⁶ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^7-10 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,¹¹ and is the primary pulse oximetry at 9 of the top 10 hospitals according to the 2020-21 U.S. News and World Report Best Hospitals Honor Roll.¹² 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 Masimo Hospital Automation™ platform, and include Iris^® Gateway, iSirona™, Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView :60™, and Masimo SafetyNet™. 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. Hotta M, Hirata K, Nozaki M, Mochizuki N, Hirano S, and Wada K. Availability of portable capnometers in children with tracheostomy. Pediatrics Int’l. 2021. DOI:10.1111/PED.14516
2. Fujimoto S, Suzuki M, Sakamoto K, et al. Comparison of End-Tidal, Arterial, Venous, and Transcutaneous PCO₂. Respir Care. 2019;64(10):1208-14.
3. Bloom BM, Grundlingh J, Bestwick JP, Harris T. The role of venous blood gas in the emergency department: a systematic review and meta-analysis. Eur J Emerg Med. 2014;21(2):81-8.
4. 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.
5. 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.
6. 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.
7. 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.
8. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
9. 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.
10. 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.
11. Estimate: Masimo data on file.
12. 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 EMMA^®. 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 EMMA, 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; 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.

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