Is the Standard Supplied by the Association for the Advancement of Medical Instrumentation the Measure of All Things for Noninvasive Continuous Hemodynamic Devices?

Fortin, Jürgen; Lerche, Katja; Flotzinger, Doris; O'Brien, Terence X.

doi:10.1097/aln.0000000000000485

Cited by 17 publications

(16 citation statements)

References 6 publications

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“…These artifacts, specifically under-damping, may lead to clinically relevant differences between actual and displayed pressure values. The impact of underdamping typically has the greatest effect on systolic pressure and the least on diastolic [19–21]. Further issues derive from its physical attributes as it can be knocked or fall off a patient, which may impact the readings.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2017

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BackgroundDespite 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.MethodsA 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.ResultsThe 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.ConclusionsIn 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.

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Section: Discussionmentioning

confidence: 99%

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

et al. 2017

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“…Unfortunately, there is currently no accepted standard to evaluate the clinical performance of this new generation of monitors. 29 A recent meta-analysis that included 28 studies that monitored BP non-invasively with various devices based on either the Peñáz principle or tonometry concluded that the inaccuracy and imprecision of continuous noninvasive BP monitoring devices are larger than what was defined as accepted by the AAMI. 30 The stability of BP during validation, the setting where the validation took place, whether non-invasive beat-to-beat BP was monitored contralaterally or ipsilaterally from reference femoral, radial, or brachial invasive BP varies among the different studies included in the meta-analysis.…”

Section: Discussionmentioning

confidence: 99%

Validation of non-invasive arterial pressure monitoring during carotid endarterectomy

Heusdens

Lof

Pennekamp

et al. 2016

British Journal of Anaesthesia

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“…Numerous validation studies were performed under divergent conditions; their results are so far not entirely satisfactory as demonstrated by large meta-analysis by Kim et al ( 21 ). On the other hand, there is currently no widely accepted standard or methodology how to evaluate the accuracy of such new devices and the Association for the Advancement of Medical Instrumentation (AAMI) standard ( 22 ) does not seem to be the best option ( 23 ).…”

Section: Contemporary Possibilities Of Continuous Nibp Assessmentmentioning

confidence: 99%

“…And finally, the CNBP readings would have to be fully reliable under all conditions. Adherence to the AAMI standards would not help us in this issue ( 23 ). The validations of current CNBP devices have been performed using the old Bland–Altman methodology, but possibly we should go further into more elaborate analyses using error grams ( 29 ), four-quadrant, and polar plots ( 30 ) as described by Critchley.…”

Section: Non-invasive Pressure Assessment To Improve Outcomementioning

confidence: 99%

Continuous Non-Invasive Arterial Pressure Assessment during Surgery to Improve Outcome

Stenglova

Beneš

2017

Front. Med.

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Blood pressure (BP) is one of the most important variables evaluated during almost every medical examination. Most national anesthesiology societies recommend BP monitoring at least once every 5 min in anesthetized subjects undergoing surgical procedures. In most cases, BP is monitored non-invasively using oscillometric cuffs. Although the risk of arterial cannulation is not very high, the invasive BP monitoring is usually indicated only in the case of high-risk patients or in complex surgical procedures. However, recent evidence points out that when using intermittent BP monitoring short periods of hypotension may be overlooked. In addition, large datasets have demonstrated that even short periods of low BP (or their cumulative duration) may have a detrimental impact on the development of postoperative outcome including increased risk of acute kidney or myocardial injury development. Recently marketed continuous non-invasive blood pressure monitoring tools may help us to recognize the BP fluctuation without the associated burden of arterial cannulation filling the gap between intermittent non-invasive cuff and continuous invasive arterial pressure. Among others, several novel devices based either on volume clamp/vascular unloading method or on applanation tonometry are nowadays available. Moreover, several near-future smart technologies may lead to better hypotension recognition or even prediction potentially improving our ability to maintain BP stability throughout the anesthesia or surgical procedure. In this review, novel or emerging technologies of non-invasive continuous blood pressure assessment and their potential to improve postoperative outcome are discussed.

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Is the Standard Supplied by the Association for the Advancement of Medical Instrumentation the Measure of All Things for Noninvasive Continuous Hemodynamic Devices?

Cited by 17 publications

References 6 publications

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

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

Validation of non-invasive arterial pressure monitoring during carotid endarterectomy

Continuous Non-Invasive Arterial Pressure Assessment during Surgery to Improve Outcome

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