Wide Range Of Arm Circumferences Research Articles

ACCURACY OF THE WATCHBP O3 DEVICE FOR AMBULATORY BLOOD PRESSURE MONITORING ACCORDING TO THE NEW CRITERIA OF THE ISO81060–2 2018 PROTOCOL

Objective: To determine the accuracy of the Microlife WatchBP O3 monitor for ambulatory blood pressure measurement according to the new ISO81060–2 2018 protocol. Design and method: The WatchBP O3 model is an oscillometric fully automatic device for blood pressure measurement at the upper arm. The device accuracy was first tested in 97 subjects from the general population (mean age, 71.3 years; 48 men) over a wide range of arm circumferences using four cuffs of different size suitable for arm circumferences ranging from 14.0 to 52.0 cm. In a second study, 36 subjects (mean age, 72.9 years; 18 men) underwent stress testing on a cycle ergometer in order to increase their heart rate by 15% or more. The new recommendations of the ISO81060–2 2018 protocol were followed. Blood pressure measurement was performed by two observers with binaural stethoscope using the same arm sequential method. Results: In the general population, the mean device–observer difference in the 291 separate blood pressure data pairs was 1.33 ± 3.18 mmHg for systolic blood pressure and was 0.73 ± 3.17 mmHg for diastolic blood pressure. These data were in agreement with criterion 1 of the protocol standard requirements (mean, less than or equal to 5 mmHg; SD, ± 8 mmHg). Also criterion 2 was satisfied being the Standard Deviations of the 97 participants well below the maximum values required by the protocol. During the ambulatory monitoring study, the minimum heart rate increase during exercise stress testing was obtained in all subjects. The average heart rate increase was 20.3% (range 15.4% to 28.9%). The mean device–observer difference in the 108 separate blood pressure data pairs was 1.51 ± 2.79 mmHg for systolic blood pressure and was 1.72 ± 2.58 mmHg for diastolic blood pressure. Also these data were in agreement with criterion 1 of the protocol standard requirements. Conclusions: These data show that the Microlife WatchBP O3 monitor satisfied the ISO 81060–2:2018 standard requirements for a general population across a wide range of arm sizes and that also the protocol criteria for validation of devices intended for ambulatory blood pressure monitoring were fulfilled.

Validation of an Automated and Adjustable Blood Pressure System for Use with a Public Health Station.

ObjectiveA new automated and adjustable blood pressure (BP) system has been developed to improve the accuracy of BP measurements on public-use health stations. This self-fitting BP system includes a mechanical cuff that wraps down to the user’s arm prior to bladder inflation. The purpose of this study was to validate the adaptable BP system (ABPS) using the current standards from the Association for the Advancement of Medical Instrumentation (AAMI).MethodsThe AAMI/ISO 81060:2013 standards for clinical validation of non-invasive automated arterial BP measurement devices were followed precisely using the same arm sequential method. For each participant, BP was measured over multiple trials by trained observers alternating a reference sphygmomanometer with the ABPS. All study requirements were met with 85 qualifying participants, each with 3 valid paired determinations.ResultsThe mean difference between ABPS BP and reference BP using all 255 paired determinations was −2.4 ± 7.7 mmHg for systolic and 1.7 ± 5.7 mmHg for diastolic. The standard deviation of the averaged paired determinations per participant was 6.3 mmHg for systolic and 5.2 mmHg for diastolic. Arm circumference measurements had a mean error of −2.1 ± 2.4 cm (R2 = 0.87). A new prediction model for arm circumference was validated using a holdout dataset (R2 = 0.94).ConclusionThe results of the study confirm that the ABPS met all benchmarks established by the AAMI. The device accurately measures BP across a wide range of arm circumferences (24–44 cm) and is suitable for use by individuals to self-monitor BP.

Cuff challenges in blood pressure measurement.

The characteristics of the optimal cuff for blood pressure (BP) measurement are still the subject of much debate. The choice of the appropriate cuff in obese individuals depends not only on the arm circumference but also on its shape because a conically shaped arm makes it difficult to fit the cuff to the arm. When a large-size cylindrical cuff is used in conical arms, an overestimation of the true BP is likely to occur with BP discrepancies that may be as large as 10mmHg. With the advent of automatic oscillometric devices, the choice of the appropriate cuff became even more controversial because with oscillometric BP measurement the reference point is not the artery occlusion but the oscillometric peak signal. To overcome the problem of miscuffing in obese individuals, special cuffs that can accommodate a wide range of arm sizes have been designed. Using these cuffs, accurate oscillometric BP measurements can be obtained over a wide range of arm circumferences using a unique software algorithm. These wide-range cuffs coupled to oscillometric devices may represent a good option for BP measurement in very obese subjects. However, their reliability should be confirmed in larger populations and different settings.

Accuracy of the WatchBP office ABI device for office blood pressure measurement over a wide range of arm sizes.

The aim of this study was to determine the accuracy of the WatchBP Office ABI monitor for office blood pressure measurement over a wide range of arm circumferences using the ANSI/AAMI/ISO 81060-2:2013 protocol. The device accuracy was tested in 88 participants whose mean±SD age was 54.5±17.6 years, whose arm circumference was 30.6±8.3 cm (range: 15-46 cm), and whose entry blood pressure (BP) was 138.3±23.4 mmHg for systolic and 83.7±14.6 mmHg for diastolic BP. Four cuffs (small, standard, large, and extra-large) suitable for arm circumferences ranging from 14.0 to 52.0 cm were used. The mean device-observer difference in the 264 separate BP data pairs was 0.7±3.8 mmHg for systolic BP and was 0.0±3.7 mmHg for diastolic BP. These data were in agreement with criterion 1 of the ANSI/AAMI/ISO 81060-2:2013 standard requirements (≤5±8 mmHg). Moreover, criterion 2 was satisfied, the mean±SD device-observer difference of the 88 participants being 0.7±3.1 and 0.0±3.2 mmHg, respectively, for systolic and diastolic BP. Good agreement between observer and device was present across the whole range of arm circumferences. These data show that the Microlife WatchBP Office ABI monitor satisfied the ANSI/AAMI/ISO 81060-2:2013 standard requirements across a wide range of arm sizes.

Validation of the A&D BP UA-651 device with a wide-range cuff for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010.

The aim of this study was to determine the accuracy of the A&D BP UA-651 device coupled to a wide-range cuff for home blood pressure (BP) measurement according to the International Protocol of the European Society of Hypertension. The device was evaluated in 33 patients. The mean age of the patients was 56.5±15.1 years. The mean systolic BP was 144.3±23.8 mmHg (range 88 : 196), the mean diastolic BP was 87.5±15.8 mmHg (range 38 : 132), and the mean arm circumference was 29.0±3.4 cm (range 22 : 36). The protocol requirements were followed precisely. The device passed all requirements, fulfilling the standards of the protocol. On average, the device overestimated the systolic BP by 0.7±3.4 mmHg and underestimated the diastolic BP by 0.8±3.6 mmHg. The measurement error was unrelated to the patient's arm circumference. These data show that the A&D BP UA-651 device coupled to a wide-range cuff fulfilled the requirements for validation by the International Protocol over a wide range of arm circumferences and can be recommended for clinical use in the adult population.

Techniques for self-measurement of blood pressure: limitations and needs for future research.

Self blood pressure measurement (SBPM) improves the overall management of hypertension provided it is implemented with methodologic care. This concerns especially the accuracy and technical requirements of blood pressure (BP) measuring devices that should be validated according to internationally accepted protocols. The use of memory-equipped automatic home monitors is strongly recommended because they reduce observer bias, avoid patients' misreporting, and allow fully automatic analysis by software. For current use, simple software should be worked out that allow for analysis of readings in an objective manner. Miscuffing is also a frequent source of measurement error in obese arms when oscillometric devices are used. Modern automatic devices can overcome this problem because of special software algorithms that can provide accurate measurements over a wide range of arm circumferences when coupled with a single cuff of standard dimensions. Tronco-conical-shaped cuffs are a key component of this instrumentation because they better fit on large conical arms frequently present in obese individuals. Semi-rigid cuffs should be increasingly used because they ensure that the proper amount of tension is applied without the intervention of the user. Continuous technology improvement of instrumentation for SBPM can be achieved through close cooperation between manufacturers and validation centers.

Accuracy of the Microlife large–extra large-sized cuff (32–52 cm) coupled to an automatic oscillometric device

To determine the accuracy of the large-extra large-sized (L-XL) cuff (32-52 cm) coupled to a Microlife WatchBP Office ABI blood pressure measuring device tested according to the requirements of the International Protocol of the European Society of Hypertension. The L-XL cuff tested in this study is designed to provide accurate blood pressure measurements in patients with large arms (arm circumference≥32 cm) over a wide range of arm circumferences using a single 145±1×320±1 mm bladder. The evaluation was made in 33 patients with a mean±standard deviation age of 53±17 years (range: 30-96 years). Their systolic blood pressure (SBP) was 142±21 mmHg (range: 110-180 mmHg), diastolic blood pressure (DBP) was 87±14 mmHg (range: 62-106 mmHg) and arm circumference was 36±5 cm (range: 32-50 cm). Blood pressure measurements were made in the sitting position. The L-XL cuff coupled to the WatchBP Office ABI passed all three phases of the European Society of Hypertension protocol for SBP and DBP. Mean blood pressure differences between device and observer were -1.3±5.1 mmHg for SBP and -1.8±5.8 mmHg for DBP. Similar device-observer differences were observed in patients divided into two subgroups according to whether their arm circumference was above or below the median in the group. These results indicate that the L-XL cuff coupled to the WatchBP Office ABI monitor provides accurate blood pressure readings in patients with large arms over a wide range of arm circumferences.

Accuracy of a single rigid conical cuff with standard-size bladder coupled to an automatic oscillometric device over a wide range of arm circumferences

Although the upper arm has the shape of a truncated cone, cylindrical cuffs and bladders are currently used for blood pressure (BP) measurement. The aims of this study were to describe upper arm characteristics and to test the accuracy of a standard adult-size conical cuff coupled to an oscillometric device over a wide range of arm circumferences. Arm characteristics were studied in 142 subjects with arm circumferences ranging from 22 to 45 cm (study 1). In a subset of 33 subjects with the same range of arm circumferences, a rigid conical cuff with standard-size bladder (12.6 × 24.0 cm) and a rigid cylindrical cuff (13.3 × 24.0 cm), both coupled to a Microlife BP A100 device, were tested according to the requirements of the protocol of the European Society of Hypertension (ESH; study 2). Study 1. In all subjects, upper-arm shape was tronco-conical with slant angles ranging from 89.5° to 82.2°. In a multiple linear regression analysis, only arm circumference was an independent predictor of conicity (P<0.001). Study 2. The rigid conical cuff passed all three phases of the ESH protocol for systolic and diastolic BPs. Mean device-observer BP differences obtained with the conical cuff were unrelated to arm circumference. When the rigid cylindrical cuff was used, ESH criteria were not satisfied, and the cuff overestimated systolic BPs in subjects with large arms. BP can be measured accurately with the use of a standard-size rigid conical cuff coupled to a BP A100 device for a wide range of arm circumferences.

Validation of the Visomat Comfort form device for home blood pressure measurement according to the International Protocol

To evaluate the accuracy of the UEBE Visomat Comfort form device for home blood pressure measurement tested following the recommendations of the International Protocol of the European Society of Hypertension. Device evaluation was performed in 33 participants with a mean +/- standard deviation age of 56.5+/-18.3 years (range 30-91 years). Their systolic blood pressure (SBP) was 143.6+/-25.3 mmHg (range 94-180 mmHg), diastolic blood pressure (DBP) was 88.8+/-15.4 mmHg (range 64-116 mmHg), and upper arm circumference was 30.2+/-3.2 cm (range 24.5-39.0 cm). BP measurements were performed in the sitting position. The Visomat Comfort form passed all three phases of the European Society of Hypertension protocol for SBP and DBP. Mean BP differences for the Visomat Comfort form (device-observer) were -2.5+/-5.9 mmHg for SBP and -2.4+/-5.4 mmHg for DBP. Similar device-observer differences were observed in the participants divided into two subgroups according to whether their arm circumference was above or below the median in the group. In conclusion, these results indicate that the UEBE Visomat Comfort form monitor can be recommended for clinical use in the adult population over a wide range of arm circumferences.

Accuracy of the BP A100 blood pressure measuring device coupled with a single cuff with standard-size bladder over a wide range of arm circumferences

The objective of this study was to determine the accuracy of the Microlife BP A100 blood pressure measuring device tested according to the requirements of the International Protocol of the European Society of Hypertension. The BP A100 model is designed to provide accurate blood pressure measurements over a wide range of arm circumferences using a single cuff with standard-size bladder. Device evaluation was performed on 33 patients with a mean +/- SD age of 59 +/- 19 years (range 30-89 years). Their systolic blood pressure (SBP) was 143 +/- 23 mmHg (range 108-180 mmHg), diastolic blood pressure (DBP) was 87 +/- 16 mmHg (range 60-108 mmHg), and arm circumference was 31 +/- 4 cm (range 22-42 cm). In nine patients, the arm circumference was at least 33 cm. Blood pressure measurements were performed in the sitting position. The BP A100 passed all three phases of the European Society of Hypertension protocol for SBP and DBP. Mean blood pressure differences between device and observer were -2.9 +/- 4.9 mmHg for SBP and -2.6 +/- 4.6 mmHg for DBP. Similar device-observer differences were observed in the patients divided into two subgroups according to whether their arm circumference was above or below the median in the group. In conclusion, the present results indicate that the Microlife BP A100 monitor coupled with a single cuff with standard size bladder provides accurate blood pressure readings over a wide range of arm circumferences.