Study Investigates the Impact of Masimo Continuous SpHb® and PVI® on Anesthesia-Related Mortality
In the prospective, single-center, observational study, Professor
The study included 18,867 patients (in the two groups), of whom 3450 underwent SpHb and PVI monitoring via Radical-7. The patients in the monitoring group received vascular filling with crystalloids or blood, according to the clinical algorithm. Demographic, anesthesia, surgical, and transfusion data were collected in electronic medical records. The researchers compared the percentage of patients in the monitored group who received transfusions within the first postoperative 48 hours to the percentage in the non-monitored group. They also compared mortality rates for each group at 30 days and 90 days following surgery.
Using the cox-proportional hazard model, the researchers found that the patients in the group monitored with SpHb and PVI had a 30% reduction in mortality at 30 days and a 25% reduction in mortality at 90 days. The proportion of patients receiving transfusions did not change significantly between the two groups (7.9% in 2013, 8.5% in 2014, p=0.1323), nor did the number of blood units transfused within 48 hours (3.4 ± 2.7 in 2013, 3.4 ± 2.0 in 2014, p>0.05). However, in non-cardiac surgery, patients were transfused sooner in the operative or recovery room (72.9% vs 56.1%, p=0.0002).
The researchers concluded that “Monitoring SpHb and PVI integrated in a vascular filling algorithm allowed earlier transfusion and reduces mortality at a scale of a whole hospital with different clinical practices (and practitioners) and unselected patients.”
“Access to continuous monitoring of Hb levels and fluid responsiveness
has changed the way we address blood and fluid management. By lowering
inadequate fluid filling at the beginning of anesthesia, we are able to
avoid diluting patients inadequately and this data helps us to guide
precisely the amount of fluids or blood that must be given to patients
on a case by case basis,” stated Professor Nathan, Head of the
SpHb monitoring may provide additional insight to the directional trend of hemoglobin between invasive blood samplings – when the SpHb trend is stable and the clinician may otherwise think hemoglobin is decreasing; when the SpHb trend is rising and the clinician may otherwise think hemoglobin is not rising fast enough; or when the SpHb trend is decreasing and the clinician may otherwise think hemoglobin is stable. SpHb monitoring, accompanied by laboratory diagnostic testing, may thus help clinicians make more timely and informed decisions, and has been shown to help clinicians provide more timely blood transfusions** and reduce blood transfusions in cases such as neurosurgery and orthopedic surgery.7,8
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*The use of the trademark SafetyNet is under license from
**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.
Nathan N et al. Impact of Continuous Perioperative SpHb Monitoring.
Proceedings from the 2016 ASA Annual Meeting,
Chicago. Abstract #A1103.
- 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.
- 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.
- Taenzer AH 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.
- Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
McGrath SP 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.
- Ehrenfeld JM et al. Continuous Non-invasive Hemoglobin Monitoring during Orthopedia Surgery: A Randomized Trial. J Blood Disorders Transf. 2014. 5:9. 2.
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.
This press release includes forward-looking statements as defined in
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934, in connection with the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements include, among others, statements regarding the potential
effectiveness of Masimo SpHb® and PVI®. These
forward-looking statements are based on current expectations about
future events affecting us and are subject to risks and uncertainties,
all of which are difficult to predict and many of which are beyond our
control and could cause our actual results to differ materially and
adversely from those expressed in our forward-looking statements as a
result of various risk factors, including, but not limited to: risks
related to our assumptions regarding the repeatability of clinical
results; risks related to our belief that
Evan Lamb, 949-396-3376