Continuous Non-invasive finger cuff CareTaker® comparable to invasive intra-arterial pressure in patients undergoing major intra-abdominal surgery. 2017

Irwin Gratz, and Edward Deal, and Francis Spitz, and Martin Baruch, and I Elaine Allen, and Julia E Seaman, and Erin Pukenas, and Smith Jean
Department of Anesthesiology, Cooper Medical School at Rowan University Cooper University Hospital, Camden, New Jersey, USA.

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. 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. 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. In this study, blood pressure measured using the non-invasive CT device was shown to correlate well with the arterial catheter measurements. Larger studies are needed to confirm these results in more varied settings. Most patients exhibited very good agreement between methods. Results were well within the limits established for the validation of automatic arterial pressure monitoring by the AAMI.

UI MeSH Term Description Entries
D008297 Male Males
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D010865 Pilot Projects Small-scale tests of methods and procedures to be used on a larger scale if the pilot study demonstrates that these methods and procedures can work. Pilot Studies,Pilot Study,Pilot Project,Project, Pilot,Projects, Pilot,Studies, Pilot,Study, Pilot
D001795 Blood Pressure Determination Techniques used for measuring BLOOD PRESSURE. Blood Pressure Determinations,Determination, Blood Pressure
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000368 Aged A person 65 years of age or older. For a person older than 79 years, AGED, 80 AND OVER is available. Elderly
D000369 Aged, 80 and over Persons 80 years of age and older. Oldest Old
D016343 Monitoring, Intraoperative The constant checking on the state or condition of a patient during the course of a surgical operation (e.g., checking of vital signs). Intraoperative Monitoring
D062186 Arterial Pressure The blood pressure in the ARTERIES. It is commonly measured with a SPHYGMOMANOMETER on the upper arm which represents the arterial pressure in the BRACHIAL ARTERY. Aortic Blood Pressure,Aortic Pressure,Aortic Pulse Pressure,Aortic Tension,Arterial Blood Pressure,Arterial Tension,Blood Pressure, Aortic,Blood Pressure, Arterial,Mean Aortic Pressure,Mean Arterial Pressure,Aortic Blood Pressures,Aortic Pressure, Mean,Aortic Pressures,Aortic Pressures, Mean,Aortic Pulse Pressures,Aortic Tensions,Arterial Blood Pressures,Arterial Pressure, Mean,Arterial Pressures,Arterial Pressures, Mean,Arterial Tensions,Blood Pressures, Aortic,Blood Pressures, Arterial,Mean Aortic Pressures,Mean Arterial Pressures,Pressure, Aortic,Pressure, Aortic Blood,Pressure, Aortic Pulse,Pressure, Arterial,Pressure, Arterial Blood,Pressure, Mean Aortic,Pressure, Mean Arterial,Pressures, Aortic,Pressures, Aortic Blood,Pressures, Aortic Pulse,Pressures, Arterial,Pressures, Arterial Blood,Pressures, Mean Aortic,Pressures, Mean Arterial,Pulse Pressure, Aortic,Pulse Pressures, Aortic,Tension, Aortic,Tension, Arterial,Tensions, Aortic,Tensions, Arterial

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