IRVINE, CA--(Marketwired - Aug 12, 2014) - Masimo (
In the study, Dr. Mario Patino, M.D., and colleagues from the Department of Anesthesiology at Cincinnati Children's Hospital, assessed the trending and point accuracy of SpHb (Revision E Disposable L Sensor R1-20/25L and ReSposable Sensor R2-20/25)) in pediatric patients versus arterial blood samples analyzed on a hematology analyzer (Cell-Dyn Sapphire). They also evaluated the impact of SpHb Invivo Adjustment on accuracy comparisons.
Researchers collected 158 SpHb and laboratory hemoglobin (Hb) data pairs and 105 delta pairs (ΔSpHb and ΔHb) from 46 patients aged 2 months to 17 years with Hb ranging from 16.7 g/dL to 7.9 g/dL. Patient selection was limited to those undergoing surgical procedures associated with substantial blood loss, such as cardiac surgery, liver/small bowel transplantation, and multilevel spine surgeries.
The primary goal of the study was to compare the magnitude and direction of change (trending) of SpHb versus that of the reference device. The authors found that the sensitivity of SpHb to correctly detect directional changes in Hb was 95% (95% CI = 0.83-0.99). The researchers calculated SpHb's correlation coefficient at r=0.76. Additionally, 95% of the individual data points were either in the upper right or in the lower left quadrant of the trending plots, showing changes in SpHb and Hb in the same direction.
Additionally, researchers found point accuracy bias and standard deviation of 0.4 +/- 1.3 g/dL and with Invivo Adjustment, 0.1 +/- 1.2 g/dL. The limits of agreement were -2.0 to 3.2 g/dL before Invivo Adjustment and -2.4 to 2.2 g/dL after Invivo Adjustment (P value = 0.04). Invivo Adjustment, a feature currently available in select European and other non-U.S. markets, allows clinicians to adjust the SpHb measurement to that of an initial blood sample analyzed with the clinician's invasive reference hemoglobin analyzer. This feature helps account for reference invasive instrument and individual patient variation.
The authors concluded that, "noninvasive, continuous Hb monitoring by Pulse CO-Oximetry (SpHb) displayed similar trending and absolute accuracy in pediatric patients undergoing a variety of surgical procedures associated with blood loss as has been found in adult surgical patients," adding that, "trending SpHb values has the potential to supplement detection of changes of Hb concentration by invasive blood draws."
SpHb is available with Masimo's rainbow® SET® monitoring platform, enabling the noninvasive assessment of multiple blood constituents and physiologic parameters that previously required invasive or complicated procedures, in addition to providing Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry. The rainbow® SET® platform -- including RRa®, SpCO® and SpMet® -- offers a breakthrough in patient safety by helping clinicians detect life-threatening conditions and helping guide treatment options.
"This study adds to the growing body of clinical evidence supporting the value of SpHb's use with pediatric patients," said Dr. Stephen Barker, M.D., Ph.D., Chairman of the Scientific Advisory Board of Masimo. "As with adult patients, SpHb can help clinicians noninvasively assess hemoglobin levels and trending, which has been shown to lead to better clinical decisions and improved patient outcomes."
1 Patino M, Schultz L, Hossain M, Moeller J, Mahmoud M, Gunter J, Kurth C. "Trending and Accuracy of Noninvasive Hemoglobin Monitoring in Pediatric Perioperative Patients" Anesthesia and Analgesia, doi: 10.1213/ANE.0000000000000369. Available online here.
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