New Study Assesses Utility of 1st Generation Masimo Pronto® Pulse CO-Oximeter® with SpHb® Spot Check Technology in Evaluating Pediatric Trauma Patients
Pronto features rainbow SET™ technology, allowing for the noninvasive spot checking of SpHb, oxygen saturation (SpO2), pulse rate (PR), and perfusion index (PI).
In the study, published online in the
Of the 114 patients, SpHb was successfully measured 89% of the time. Mean lab hemoglobin was 12.6 ± 1.9 and mean SpHb was 12.3 ± 1.6 (mean point-of-care hemoglobin was 12.2 ± 2.0). Bland-Altman analysis showed the limits of agreement between lab hemoglobin and non-invasive SpHb to be -2.9 and 1.9, with a mean difference of -0.49.
The researchers concluded that they were able to demonstrate “low bias and strong correlation between hemoglobin measurements using a noninvasive monitor, a point-of-care testing device, and laboratory co-oximeter in pediatric trauma patients.” They noted that noninvasive SpHb testing “may be most effective in determining when invasive testing of hemoglobin is warranted.”
Key limitations to the study include: the majority of the hemoglobin values measured were within normal limits; limited data on injury severity, morbidity, and mortality to understand their effects on device accuracy and precision; data is based on a convenience sample depending on availability of certified personnel; and no assessment on the effects of pre-hospital administration of intravenous fluids.
The researchers noted that “[f]urther study is required to determine the clinical utility of the [Pronto] device during the initial assessment and its accuracy in evaluating hemoglobin levels in hemodynamically unstable patients.” They stated that SpHb measurements should not be relied upon alone to determine active hemorrhage or the need for transfusion, and suggested the following reasons a noninvasive measurement could not be taken in 11% of the study’s participants: severe anemia; patients who were normotensive but tachycardic; patients unreadable due to the presence of nail polish; and cold extremities or low signal IQ without hemodynamic instability or anemia.
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Ryan, Maxwell, Manning, Jacobs, Bachier-Rodriguez, Felizm, and
Williams. “Noninvasive hemoglobin measurement in pediatric trauma
Journal of Trauma and Acute Care Surgery. DOI: 10.1097/TA.0000000000001160. E-published ahead of print.
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care by taking noninvasive monitoring to new sites and applications. 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® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world. 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. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.
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Irene Paigah, 858-859-7001