Edwards HemoSphere

HemoSphere Advanced Monitor 12 Advanced Features
161
Table 12-7 and Table 12-8 provide the hypotensive event occurrence percentage and time-to-event data for
a given P(↓BP) Range (%) for patients in the clinical validation study. These data are presented using time
windows that have been selected based upon how fast hypotensive events developed on average in OR and
ICU patients. Therefore based upon the clinical validation study data, Table 12-7 presents data for OR
patients for a time-window of 15 minutes and Table 12-8 presents data for ICU patients for a time-window
of 120 minutes. These data demonstrate that the HPI algorithm predicts hypotension with equal
performance in surgical and ICU patients; however, due to experiential differences in the OR (e.g.,
anesthesia, surgical interventions and administrations of therapies), the mean time-to-event was shown to be
less in the OR, with the difference being more pronounced at lower ranges of P(↓BP) values. At higher
values of ranges of P(↓BP) values, particularly in the 80-84% range and above (High Alert popup range), the
time to event data are comparable.
CAUTION The P(↓BP) parameter information provided in Tables 12-7 and 12-8 is presented as
general guidance and may not be representative of individual experience. A review of
the patient’s hemodynamics is recommended prior to initiating treatment. See Clinical
Application on page 158.
Table 12-7 OR
P(↓BP) Range (%) Event Rate (%)
Time-to-Event in minutes:
Median [10
th
percentile,
90
th
percentile]
10-14 14.2 8.0 [4.7, 12.7]
15-19 16.6 6.7 [3.3, 12.6]
20-24 15.4 7.0 [3.3, 14.0]
25-29 16.9 7.8 [3.7, 13.4]
30-34 22.5 9.0 [3.7, 14.0]
35-39 27.4 8.0 [3.3, 13.3]
40-44 31.8 8.3 [3.0, 13.7]
45-49 40.4 8.3 [3.3, 13.7]
50-54 43.4 7.7 [2.7, 13.3]
55-59 44.3 7.3 [3.0, 13.1]
60-64 57.0 6.7 [2.7, 12.8]
65-69 56.8 5.7 [2.3, 12.3]
70-74 67.2 5.7 [2.0, 11.7]
75-79 81.0 4.7 [2.0, 11.0]
80-84 84.2 5.0 [1.7, 12.3]
85-89 92.9 4.0 [1.7, 10.3]
90-94 95.8 3.7 [1.3, 10.0]
95-99 97.6 1.3 [0.3, 8.0]
Status = Released Printed Date: 2018-01-16 Released Date: 2017-09-14