Masimo (NASDAQ: MASI) announced today the findings of an abstract recently presented at Euroanaesthesia 2020 in which Dr. Saraçoğlu and colleagues at Marmara University in Istanbul, Turkey investigated the efficacy of Masimo noninvasive and continuous hemoglobin monitoring, SpHb®, as part of the transfusion management of pediatric patients undergoing major surgery.1 The researchers found that use of SpHb was associated with decreased rate of postoperative transfusion, reduced length of ICU stay, and other improved outcomes.

 

Masimo Root with SpHb
Masimo Root® with SpHb®
Noting that traditional methods of measuring hemoglobin and estimating blood loss as part of perioperative blood transfusion management are "time consuming" and may cause delays in decision making, the researchers sought to investigate whether use of a noninvasive, continuous method, Masimo SpHb, would have an impact on transfusion rates, morbidity, and mortality in pediatric patients undergoing craniosynostosis surgery.
 
Pediatric patients aged 2-24 months were divided into a control group (n = 28), whose transfusion therapy was managed using intermittent blood gas analysis, and an experimental group (n = 27), whose transfusion therapy was managed using SpHb monitored with Masimo rainbow® sensors connected to a Radical-7® Pulse CO-Oximeter®.

In both groups, blood gas analysis was performed hourly during the perioperative period; in the SpHb group, when SpHb monitoring indicated a sudden decrease in hemoglobin, blood gas analysis was simultaneously performed.

 

The researchers calculated the following statistically significant (p < 0.05) results:

Outcome Control Group SpHb Group P-value
Length of stay in ICU 55.43 hours ± 25.34 hours (48 hours median) 33.48 hours ± 12.25 hours (24 hours median) 0.001
Postoperative drainage 215.54 mL ± 93.1 mL 136.85 mL ± 62.27 mL 0.001
Postoperative red blood cell transfusion 179.02 mL ± 163.06 mL (145 mL) 102.69 mL ± 73.87 mL (105 mL) 0.033
Postoperative fresh frozen plasma transfusion 71.96 mL ± 94.95 mL (25 mL) 28.15 mL ± 64.35 mL (0 mL) 0.043
Perioperative crystalloid 396.79 mL ± 171.16 mL (350 mL) 462.59 mL ± 158.91 mL (500 mL) 0.048
First platelet level in ICU 270,821 ± 74,474 327,185 ± 104,644 0.025
Last lactate level in ICU 1.47 mmol/L ± 0.64 mmol/L (1.25 mmol/L) 1.18 mmol/L ± 0.63 mmol/L (0.9 mmol/L) 0.044

 

They found that the length of stay in the ICU was statistically significantly higher in the control group than the SpHb group. Postoperative drainage, red blood cell transfusion, and fresh frozen plasma transfusion in the ICU were also statistically significantly higher in the control group than the SpHb group. Lactate levels were higher in the SpHb group at the start of the operation, but higher in the control group at the end.

The researchers concluded, "Noninvasive continuous hemoglobin monitoring in major hemorrhagic surgeries in pediatric patients might be effective in reducing morbidity not only by reducing the amount of transfusion but also [by] leading to less metabolic and hemodynamic instability."

In other clinical studies, conducted with adult patients, continuous monitoring with SpHb as part of patient blood management (PBM) programs has been found to improve outcomes, such as reducing the percentage of patients receiving transfusions,2 reducing the units of red blood cells transfused per patient,3-4 reducing the time to transfusion,5 reducing costs,6 and even reducing mortality 30 and 90 days after surgery by 33% and 29%, respectively.7 The evidence of SpHb’s impact on outcomes spans the globe, representing 6 countries on 4 different continents.2-8 Today, SpHb technology supports clinicians in over 75 countries around the world.9 

SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors, patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.

Learn more https://www.masimo.co.uk/technology/co-oximetry/sphb/

 

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References

1.     Saraçoğlu A , Orhon Ergün M, Sakar M, Uyar E, Saçak B, Aykaç Z. The use of SpHb in pediatric patients undergoing major surgery associated with reduced morbidity. Proceedings from the Euroanaesthesia 2020 Annual Meeting. #5291.

2.     Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedic Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.

3.     Awada WN et al. Continuous and noninvasive hemoglobin monitoring reduces red blood cell transfusion during neurosurgery: a prospective cohort study. J Clin Monit Comput. 2015 Feb 4.

4.     Imaizumi et al. Continuous and noninvasive hemoglobin monitoring may reduce excessive intraoperative RBC transfusion. Proceedings from the 16th World Congress of Anaesthesiologists, Hong Kong. Abstract #PR607.

5.     Kamal AM et al. The Value of Continuous Noninvasive Hemoglobin Monitoring in Intraoperative Blood Transfusion Practice During Abdominal Cancer Surgery. Open J Anesth. 2016;13-19.

6.     Ribed-Sánchez B et al. Economic Analysis of the Reduction of Blood Transfusions during Surgical Procedures While Continuous Hemoglobin Monitoring is Used. Sensors. 2018, 18, 1367; doi:10.3390/s18051367.

7.     Cros J et al. Continuous hemoglobin and plethysmography variability index monitoring can modify blood transfusion practice and is associated with lower mortality. J Clin Monit Comp. 3 Aug 2019. https://doi.org/10.1007/s10877-019-00367-z.

8.     Merolle L, Marraccini C, Di Bartolomeo E, Montella M, Pertinhez T, Baricchi R, Bonini A. Postoperative patient blood management: transfusion appropriateness in cancer patients. Blood Transfus 2020; 18: 359-65 DOI 10.2450/2020.0048-20.

9.     Masimo data on file.

10.   Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at https://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.

11.   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.

12.   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;Jan 8;338.

13.   Taenzer A et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.

14.   Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.

15.   McGrath S et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.

16.   McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.

17.   Estimate: Masimo data on file.

18.   http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview

 

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