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

Neuchatel, Switzerland--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) today announced the results of an observational retrospective study published in the International Journal of Pediatrics.In this study, researchers at Osaka Women's and Children's Hospital in Japan found that the Masimo EMMA® portable capnometer "can be used to assess the respiratory status of children undergoing tracheotomy."1 EMMA® is available in a compact form for patients of all ages A seamless mainstream capnograph, an easy-to-carry device.The device requires no routine calibration, has minimal warm-up time, and displays accurate end-tidal carbon dioxide (EtCO2) and respiratory rate measurements as well as a continuous EtCO2 waveform within 15 seconds.
Noting the potential value of a compact and portable way to monitor changes in patients' respiratory status in situations where typical inpatient hospital monitoring equipment is unlikely to be available, Dr. Masashi Hotta and colleagues sought to assess the utility of EMMA capnography in children by comparing data from EtCO2 values ​​from the EMMA device (attached to the distal end of the tracheostomy tube) and invasively measured venous partial pressure of carbon dioxide (PvCO2) for tracheotomy.While arterial partial pressure of carbon dioxide (PaCO2) is considered the gold standard for assessing respiratory status, the researchers chose PvCO2 because "taking arterial samples is more invasive than taking venous samples," noting that studies have shown that PaCO2 and PvCO2.2,3 They recruited 9 infants (median age 8 months) and compared a total of 43 pairs of EtCO2-PvCO2 readings.
The researchers found a correlation coefficient between EtCO2 and PvCO2 readings of 0.87 (95% confidence interval 0.7 – 0.93; p < 0.001).Analysis of the data showed that EtCO2 readings were on average 10.0 mmHg lower than the corresponding PvCO2 values ​​(95% agreement limit was 1.0 – 19.1 mmHg).The researchers speculate that the trend for EtCO2 to be lower than PvCO2 could be explained by "gas mixing near the tracheostomy tube due to the presence of anatomical and physiological dead space. Since almost all patients used tubes without cuffs, this may have occurred Some leaks. Also, about two-thirds of the patients have [chronic lung disease or bronchopulmonary dysplasia], which they point out has been shown to contribute to CO2 during exhalation compared to the partial pressure of CO2 in the blood Concentration decreased.
They also found that median differences in readings collected while patients were receiving mechanical ventilation were significantly greater (28 of 43 data pairs).The median difference was 11.2 mmHg (6.8 – 14.3) with ventilator use and 6.6 mmHg (4.1 – 9.0) without ventilator (p = 0.043).The researchers noted that ventilator use was significantly associated with differences in paired readings because patients on ventilators had respiratory or circulatory conditions.
"We demonstrate a strong positive relationship between PvCO2 and EtCO2 and reveal the usability and utility of this capnometer for children undergoing tracheotomy," the researchers concluded, "EMMA can be used for Assessing the respiratory status of children undergoing tracheotomy. EMMA is particularly useful in home care settings and outpatient settings for such children." They also noted, "The main strength of this study is that we used a portable capnometer to assess EtCO2."
Masimo (NASDAQ: MASI) is a global medical technology company that develops and manufactures a broad 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 the cost of care.Introduced in 1995, the Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximeter has proven its performance over other pulse oximeter technologies in over 100 independent and objective studies.4 Masimo SET® has also been shown to help clinicians reduce severe retinopathy in preterm infants,5 improve CCHD screening in neonates,6 and reduce rapid response team effort when using Masimo Patient SafetyNet™ for continuous monitoring in the post-operative ward. Activation, ICU transfers and costs.7-10 estimates that Masimo SET® will be used by more than 200 million patients in leading hospitals and other healthcare facilities around the world,11 according to the 2020-21 U.S. News & World Report Best Hospitals Honor Roll,11 and is one of the top 10 hospitals of 9 main pulse oximeters.12 Masimo continues to improve SET®, and in 2018 announced that the RD SET® sensor’s SpO2 accuracy under motion conditions has improved significantly, providing clinicians with greater confidence that the SpO2 values ​​they rely on accurately reflect the patient’s physiological state.In 2005, Masimo introduced rainbow® Pulse CO-Oximetry technology, which enables non-invasive and continuous monitoring of blood components previously only invasively measured, 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 launched the Root® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and extensible as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key additions to Masimo include the next-generation SedLine® Brain function monitoring, O3® regional oxygen saturation and ISA™ capnography with NomoLine® sampling line.Masimo's line of continuous and spot-check monitoring, Pulse CO-Oximeters®, includes devices designed for use in a variety of clinical and non-clinical scenarios, including cordless wearable technologies such as Radius-7® and Radius PPG™, portable devices such as Rad-67™, Fingertip pulse oximeters such as the MightySat® Rx and devices that can be used in the hospital and at home such as the Rad-97®.Masimo hospital automation and connectivity solutions are centered on the Masimo Hospital Automation™ platform and include Iris® Gateway, iSirona™, Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView:60™ and Masimo SafetyNet™.For more information about Masimo and its products, visit 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 cannot be marketed in the United States.The trademark Patient SafetyNet is used under license from the University HealthSystem Consortium.
This press release includes 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 with respect to the Private Securities Litigation Reform Act of 1995.These forward-looking statements include: Other, statements regarding the potential effectiveness of EMMA®.These forward-looking statements are based on current expectations of future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict, many of which are beyond our control and could cause our actual results to differ from those due to various risks Factors contributing to the risks we express in our forward-looking statements include, but are not limited to: risks related to our assumptions about the reproducibility of clinical results; related to our belief that Masimo's unique non-invasive measurement technologies, including EMMA, contribute to positive clinical risks associated with outcomes and patient safety; risks associated with our belief that Masimo's non-invasive medical breakthroughs provide cost-effective solutions and unique advantages; risks associated with COVID-19; and our filings with the Securities and Exchange Commission ("SEC") Additional factors discussed in the "Risk Factors" section of the latest report are available free of charge on 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 to be correct.All forward-looking statements contained in this press release are expressly qualified in their entirety by the above cautionary statements.Please be careful not to place undue reliance on these forward-looking statements, which speak only today.We undertake no obligation to update, revise or clarify these statements or the "Risk Factors" contained in our most recent report to the SEC, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
A new study finds that the Masimo EMMA® Capnograph can be used to assess breathing in children with tracheostomy.

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  • Post time: Jun-20-2022