September 9, 2004.
Masimo, the innovator of Signal Extraction Pulse Oximetry, today announced the publication in the September American Journal of Respiratory and Critical Care Medicine of a new study investigating automatically controlled oxygen therapy in preterm infants.(1) Urschitz et al. developed a closed loop inspired oxygen (FiO2) system to automatically control the inspired oxygen fraction delivered to preterm infants in order to replace the time-consuming and often inappropriate practice of routine manual control. The study took place in Germany and used a randomized, controlled cross-over trial involving 12 preterm infants.
Managing the inspired oxygen levels of preterm infants has been considered an important step in preventing oxygen-associated diseases such as ROP (Retinopathy of Prematurity), which can cause severe eye disability including blindness, and chronic lung disease. Excessive oxygen delivery as well as large fluctuations in oxygen delivery are thought to be primary contributors to preterm infant morbidity. Previously, Dr. Michael Urschitz and Dr. Christian Poets from the department of neonatology at Tuebingen, Germany, and a multi-institutional team of researchers published a study titled "Use of Pulse Oximetry in Automated Oxygen Delivery to Infants."(2) In this study, they showed that Masimo SET correctly detected 217 of 223 true hypoxemia episodes for a sensitivity of 97%. The researchers reported that four of the six hypoxemias were missed due to the sensor being off the patient's skin. But all 6 were associated with the Masimo Low Signal IQ message. Signal IQ™ was further investigated and found to have excellent specificity (75%) and sensitivity (100%). Signal IQ is Masimo's unique signal identification and quality indicator that helps clinicians identify readings of questionable validity due to extremely challenging conditions. The researchers concluded that, "With the sensitivity and specificity of Masimo SET pulse oximetry measurement as well as Signal IQ, oxygen delivery to premature and/or critically ill infants may be optimized and perhaps automated."
In the new study, a statistically significant difference was shown to exist between automated oxygen adjustments and routine manual control with respect to the frequency of oxygen adjustments and the ability to keep the infant within a targeted oxygenation range. The researchers found that automatic oxygen control successfully kept the infants within the target range 91% of the time, whereas routine manual control was successful only 81.7% of the time. Because keeping oxygen stable and within the target range is so important in eliminating oxygen-related diseases such as ROP, the difference in success rates between automated and manual control is highly significant.
Michael Urschitz, MD of the Department of Neonatology at Tuebingen, Germany, said, "It's generally accepted that precise delivery of inspired oxygen is crucial to helping infants survive and avoid retinopathy of prematurity and chronic lung disease. Automatic oxygen control may help to reach that goal. However, prior to the introduction of Masimo SET technology, pulse oximeters were too unreliable. High artifact rates, as high as 90%, were the reality. We have spent a lot of time on the development of an algorithm for automatic oxygen control that is robust to motion artifacts. This is important, because automatically adjusting the inspired oxygen as a result of motion artifacts (saturation values are falsely low) would lead to hyperoxic episodes. This could be harmful to preterm infants and should be strictly avoided. Masimo SET has reduced those artifacts and increased the detection of hypoxic and hyperoxic episodes by reading through motion and low perfusion situations. This advancement has made pulse oximetry a useful tool for automatic oxygen control. In fact, using Masimo SET Oximetry was the breakthrough in the development of our automatic oxygen control system."
Joe Kiani, CEO of Masimo, stated, "This is a ground breaking study. Never before had any researcher shown this kind of success with automation of oxygenation. The fact that Masimo SET was a key component to the automated oxygen management system implemented by this group of clinicians makes us all proud. We hope that more lifesaving applications result from the advent of Signal Extraction Oximetry"
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