PMCID: PMC5361833
PMID: 28327093
Continuous Non-invasive finger cuff
CareTaker® comparable to invasive intra-arterial pressure in patients
undergoing major intra-abdominal surgery
Irwin Gratz,1 Edward Deal,1 Francis Spitz,1
Martin Baruch,2 I. Elaine Allen,3 Julia E. Seaman,4 Erin Pukenas,1 and Smith
Jean1
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Associated Data
Data Availability Statement
The datasets generated during and analysed
for the current study are available from the corresponding author on reasonable
request.
Abstract
Background
Despite increased interest in non-invasive
arterial pressure monitoring, the majority of commercially available
technologies have failed to satisfy the limits established for the validation
of automatic arterial pressure monitoring by the Association for the
Advancement of Medical Instrumentation (AAMI). According to the ANSI/AAMI/ISO
81060–2:2013 standards, the group-average accuracy and precision are defined as
acceptable if bias is not greater than 5 mmHg and standard deviation is not
greater than 8 mmHg. In this study, these standards are used to evaluate the
CareTaker® (CT) device, a device measuring continuous non-invasive blood
pressure via a pulse contour algorithm called Pulse Decomposition Analysis.
Methods
A convenience sample of 24 patients
scheduled for major abdominal surgery were consented to participate in this IRB
approved pilot study. Each patient was monitored with a radial arterial
catheter and CT using a finger cuff applied to the contralateral thumb.
Hemodynamic variables were measured and analyzed from both devices for the
first thirty minutes of the surgical procedure including the induction of
anesthesia. The mean arterial pressure (MAP), systolic and diastolic blood
pressures continuously collected from the arterial catheter and CT were
compared. Pearson correlation coefficients were calculated between arterial
catheter and CT blood pressure measurements, a Bland-Altman analysis, and polar
and 4Q plots were created.
Results
The correlation of systolic, diastolic, and
mean arterial pressures were 0.92, 0.86, 0.91, respectively (p < 0.0001 for
all the comparisons). The Bland-Altman comparison yielded a bias (as measured
by overall mean difference) of −0.57, −2.52, 1.01 mmHg for systolic, diastolic,
and mean arterial pressures, respectively with a standard deviation of 7.34, 6.47, 5.33 mmHg for systolic, diastolic, and mean arterial
pressures, respectively (p < 0.001 for
all comparisons). The polar plot indicates little bias between the two methods
(90%/95% CI at 31.5°/52°, respectively, overall bias = 1.5°) with only a small
percentage of points outside these lines. The 4Q plot indicates good
concordance and no bias between the methods.
