Study Evaluates Performance of Masimo SpHb® in Trauma Patients with Low Hemoglobin Levels
In the prospective, observational study, Dr. Gamal and colleagues sought
to evaluate SpHb measurements on trauma patients with low hemoglobin
levels (below 8 g/dL) because trauma patients are “vulnerable to
frequent blood transfusion.” They enrolled 70 adult patients with
hemoglobin levels lower than 8 g/dL who were admitted to the emergency
department (ED) of
A total of 184 samples with corresponding SpHb values were collected for final analysis. The distribution of LabHb values was 20 (11%) below 6 g/dL, 97 (53%) between 6-7 g/dL, and 67 (36%) between 7-8 g/dL. The accuracy of SpHb in comparison to LabHb was assessed using Bland-Altman analysis. The level of agreement between SpHb and LabHb showed a bias of 0.12 g/dL and limits of agreement of -0.56 g/dL and 0.79 g/dL.
To determine the accuracy of SpHb as a trend measurement, the researchers also observed the change in hemoglobin (DeltaHb) before and after each unit of blood was transfused, for both methods. The level of agreement between DeltaSpHb and DeltaLabHb showed a bias of -0.05 g/dL and limits of agreement of -0.62 g/dL and 0.51 g/dL.
The researchers concluded that “SpHb showed accurate precision in both absolute values and trend values compared to LabHb measurement in trauma patients with low hemoglobin levels.” They also suggested several possible uses for SpHb, including as “a trend monitor that would alert the physician to any sudden bleeding mishaps,” and as a “good supplementary measure” to LabHb that can “save time and effort.”
The researchers acknowledged that this study is not sufficient to alone
answer the question, “Can we transfuse blood relying solely on SpHb or
not?” However, they noted that their findings add to the body of
evidence in favor of SpHb and suggest the need for additional research
regarding the role of
SpHb monitoring is not intended to replace laboratory blood testing. Blood samples should be analyzed by laboratory instruments prior to clinical decision making.
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The accuracy specification of SpHb is 1 g/dL ARMS* in the range of 8-17 g/dL. SpHb accuracy has been validated on healthy adult male and female volunteers and on surgical patients with light to dark skin pigmentation against an invasive laboratory device. SpHb accuracy has not been validated in conditions of motion or low perfusion.
*ARMS accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within ± ARMS of the reference measurements in a controlled study.
Gamal M, Abdelhamid B, Zakaria D, Abd El Dayem O, Ashraf R, Fawzy M,
and Hasanin A. Evaluation of noninvasive hemoglobin monitoring in
trauma patients with low hemoglobin levels. Shock.
July 2017. DOI: 10.1097/SHK. 0000000000000949.
ORi has not received
*The use of the trademark Patient SafetyNet is under license from
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Masimodata on file.
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®. 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