Business Wire06.29.17
Masimo is sharing the findings of a study that evaluated the potential clinical utility of Masimo Oxygen Reserve Index (ORi) as an early warning of arterial hemoglobin desaturation in critically ill patients.1
ORi is a relative indicator of the partial pressure of oxygen in arterial blood (PaO2) in the range of 100 to 200 mmHg. ORi is intended to supplement, not replace, oxygen saturation (SpO2) monitoring and PaO2 measurements. As an “index” parameter with a unit-less scale between 0 and 1, ORi can be trended and has optional alarms to notify clinicians of changes in a patient’s oxygen reserve.
In the prospective, collaborative, observational study, Dr. Leonard Lee and colleagues at UC Davis School of Medicine enrolled 40 adult critically ill patients who were scheduled for elective surgical procedures requiring endotracheal intubation and planned arterial pressure monitoring catheter placement prior to induction of general anesthesia. The patients’ ORi values were measured using a Masimo Radical-7 Pulse CO-Oximeter. The researchers recorded the time elapsed from the start of ORi alarming (triggered by decrease in the absolute value and rate of change in ORi) to 94 percent oxygen saturation, as well as the time elapsed from 98 percent to 94 percent saturation. The average time interval between the start of ORi alarming and 98% saturation was considered to be the average increase in warning time provided by ORi.
The researchers found that among the patients, the average time from the start of ORi alarming to 94 percent oxygen saturation was 80±38 seconds (ranging from 29 to 227 seconds). The average time from 98 percent to 94 percent saturation was 46±23 seconds (ranging from 12 to 108) seconds. Therefore, the average increase in warning time provided by ORi was 34±23 seconds (ranging from 4 to 119) seconds. On a percentage basis, the increase provided by ORi was 96 percent ± 92 percent (ranging from 5 percent to 479 percent).
The researchers concluded that the study “demonstrates the potential utility of ORi as an advanced warning of arterial desaturation and as an adjunct to SpO2. This additional warning time can potentially translate to improved patient safety by allowing earlier calls for help, assistance from a more experienced person, or modification of airway management. For this analysis we defined the advance warning to end at 98 percent SpO2. In clinical situations this SpO2 might not be considered to be critical. Using a lower SpO2 as the alarm level would increase the advance warning provided by ORi. Further analysis of the correlation of ORi and PaO2, the use of ORi as a guide to pre-oxygenation, and its utility in the morbidly obese are areas for future study.”
In another recent study, researchers at Children’s Medical Center in Dallas, Texas, concluded that ORi could provide clinicians with a median of 31.5 seconds advanced warning of impending desaturation in pediatric patients with induced apnea after pre-oxygenation.2
ORi has not received U.S. Food and Drug Administration 510(k) clearance and is not available for sale in the United States.
References
1. Lee L, Singh A, Applegate R, and Fleming N. Oxygen Reserve Index: An early warning for desaturation in critically ill patients. Proceedings from the 2017 IARS Annual Meeting, Washington, DC. Abstract #A1406.
2. Szmuk P et al. Oxygen Reserve Index A Novel Noninvasive Measure of Oxygen Reserve—A Pilot Study. Anesthesiology. 4 2016, Vol. 124, 779-784. doi:10.1097/ALN.0000000000001009.
Masimo develops noninvasive monitoring technologies. In 1995, the company debuted Masimo SET Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 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), and more recently, Pleth Variability Index (PVi) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2 pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.
References
1. 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.
2. 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;338.
3. Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
ORi is a relative indicator of the partial pressure of oxygen in arterial blood (PaO2) in the range of 100 to 200 mmHg. ORi is intended to supplement, not replace, oxygen saturation (SpO2) monitoring and PaO2 measurements. As an “index” parameter with a unit-less scale between 0 and 1, ORi can be trended and has optional alarms to notify clinicians of changes in a patient’s oxygen reserve.
In the prospective, collaborative, observational study, Dr. Leonard Lee and colleagues at UC Davis School of Medicine enrolled 40 adult critically ill patients who were scheduled for elective surgical procedures requiring endotracheal intubation and planned arterial pressure monitoring catheter placement prior to induction of general anesthesia. The patients’ ORi values were measured using a Masimo Radical-7 Pulse CO-Oximeter. The researchers recorded the time elapsed from the start of ORi alarming (triggered by decrease in the absolute value and rate of change in ORi) to 94 percent oxygen saturation, as well as the time elapsed from 98 percent to 94 percent saturation. The average time interval between the start of ORi alarming and 98% saturation was considered to be the average increase in warning time provided by ORi.
The researchers found that among the patients, the average time from the start of ORi alarming to 94 percent oxygen saturation was 80±38 seconds (ranging from 29 to 227 seconds). The average time from 98 percent to 94 percent saturation was 46±23 seconds (ranging from 12 to 108) seconds. Therefore, the average increase in warning time provided by ORi was 34±23 seconds (ranging from 4 to 119) seconds. On a percentage basis, the increase provided by ORi was 96 percent ± 92 percent (ranging from 5 percent to 479 percent).
The researchers concluded that the study “demonstrates the potential utility of ORi as an advanced warning of arterial desaturation and as an adjunct to SpO2. This additional warning time can potentially translate to improved patient safety by allowing earlier calls for help, assistance from a more experienced person, or modification of airway management. For this analysis we defined the advance warning to end at 98 percent SpO2. In clinical situations this SpO2 might not be considered to be critical. Using a lower SpO2 as the alarm level would increase the advance warning provided by ORi. Further analysis of the correlation of ORi and PaO2, the use of ORi as a guide to pre-oxygenation, and its utility in the morbidly obese are areas for future study.”
In another recent study, researchers at Children’s Medical Center in Dallas, Texas, concluded that ORi could provide clinicians with a median of 31.5 seconds advanced warning of impending desaturation in pediatric patients with induced apnea after pre-oxygenation.2
ORi has not received U.S. Food and Drug Administration 510(k) clearance and is not available for sale in the United States.
References
1. Lee L, Singh A, Applegate R, and Fleming N. Oxygen Reserve Index: An early warning for desaturation in critically ill patients. Proceedings from the 2017 IARS Annual Meeting, Washington, DC. Abstract #A1406.
2. Szmuk P et al. Oxygen Reserve Index A Novel Noninvasive Measure of Oxygen Reserve—A Pilot Study. Anesthesiology. 4 2016, Vol. 124, 779-784. doi:10.1097/ALN.0000000000001009.
Masimo develops noninvasive monitoring technologies. In 1995, the company debuted Masimo SET Measure-through Motion and Low Perfusion pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 16 of the top 20 hospitals listed in the 2016-17 U.S. News and World Report Best Hospitals Honor Roll.7 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), and more recently, Pleth Variability Index (PVi) and Oxygen Reserve Index (ORi), in addition to SpO2, pulse rate, and perfusion index (PI). In 2014, Masimo introduced Root, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect (MOC-9) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7 wearable patient monitor, iSpO2 pulse oximeter for smartphones, and the MightySat fingertip pulse oximeter.
*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.
References
1. 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.
2. 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;338.
3. Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
5. Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
6. Estimate: Masimo data on file.
7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.