Δευτέρα 4 Νοεμβρίου 2019

Accuracy testing of a new optical device for noninvasive estimation of systolic and diastolic blood pressure compared to intra-arterial measurements
Objective The objective of this study was to compare the systolic (S) and diastolic (D) blood pressure (BP) estimations from a new optical device at the wrist with invasive measurements performed on patients scheduled for radial arterial catheterization in the ICU. Optical signals were automatically processed by a library of algorithms from Aktiia SA (OBPM – optical blood pressure monitoring algorithms). Methods A total of 31 participants from both sexes, aged 32–87 years, were enrolled in the study (NCT03837769). The measurement protocol consisted of the simultaneous recording of reflective photoplethysmographic signals (PPG) from the cuffless optical device and the reference BP values recorded by a contralateral radial arterial catheter. From the 31 participants, 23 subjects whose reference data quality requirements were adequate were retained for further analysis. The PPG signals from these patients were then automatically processed by the Aktiia OBPM library of algorithms, which generated uncalibrated estimates of SBP and DBP. After the automatic assessment of optical signal quality, 326 pairs of uncalibrated SBP and DBP determinations from 16 patients were available for analysis. These values were finally transformed into calibrated estimations (in mmHg) using arterial catheter SBP and DBP values, respectively. Results For SBP, a mean difference (±SD) of 0.0 ± 7.1 mmHg between the arterial catheter and the optical device values was found, with 95% limits of agreement in the Bland-Altman method of –11.9 to + 12.2 mmHg (correlation of r = 0.87, P < 0.001). For DBP, a mean difference (±SD) of 0.0 ± 2.9 mmHg between arterial catheter and the optical device values was found, with 95% limits of agreement in the Bland-Altman method of –4.8 to + 5.5 mmHg (correlation of r = 0.98, P < 0.001). Conclusion SBP and DBP values obtained by radial artery catheterization and those obtained from optical measurements at the wrist were compared. The new optical technique appears to be capable of replacing more traditional methods of BP estimation. * Retired Received 5 August 2019 Accepted 20 October 2019 Correspondence to Josep Solà, PhD, Aktiia SA, Neuchâtel, Switzerland. Tel: +41 32 552 20 52; e-mail: josep@aktiia.com Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.
Can an automatic oscillometric device replace a mercury sphygmomanometer on blood pressure measurement? a systematic review and meta-analysis
Objective: A mercury sphygmomanometer has been considered a gold standard for measuring blood pressure. However, by the Minamata Convention on Mercury, the traditional mercury sphygmomanometer is being replaced by an automated oscillometric device. This study aimed to provide scientific evidence to determine whether an automated oscillometric device can replace a mercury sphygmomanometer and if it is applicable in routine practice. Methods: MEDLINE, EMBASE, the Cochrane Library, and CINAHL were searched on 4 May 2018. Studies comparing blood pressure measurements between automated oscillometric devices and mercury sphygmomanometers were included. Study characteristics were abstracted using the evidence table, and random-effects meta-analyses were conducted. Results: Data were compiled from 24 studies comprising 47 759 subjects. The results of meta-analysis showed that automated oscillometric devices measured lower than mercury sphygmomanometers for both systolic blood pressure (mean differences −1.75 mmHg, 95% confidence intervals: −3.05 to −0.45, I2 = 91.0%) and diastolic blood pressure (mean differences −1.20 mmHg, 95% confidence intervals: −2.16 to −0.24, I2 = 95.0%). In sub-group analyses by manufacturer, BpTRU measured lower than the mercury sphygmomanometer and OMRON showed no difference compared to the mercury sphygmomanometer for both systolic and diastolic blood pressure, but the results differed depending on the devices. Conclusion: As a result of this review, the difference in blood pressure between the mercury sphygmomanometer and the automated oscillometric device was within 5 mmHg, but the heterogeneity between the studies was very high. The automated oscillometric devices showed differences in blood pressure results according to the manufacturer and product type. Received 12 June 2019 Accepted 18 September 2019 Correspondence to Seong-Hi Park, PhD, School of Nursing, Soonchunhyang University, 22 Soonchunhyang-ro, Shinchang-myeon, Asan, Chungnam 31538, Korea. Tel: +82 41 530 4854; fax: +82 41 570 2498; e-mail: shpark2015@sch.ac.kr Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.
Validation of the HL868ED upper-arm blood pressure monitor for clinical use and self-measurement according to the European Society of Hypertension International Protocol revision 2010
Objective: The aim of this study was to evaluate the accuracy of the automated oscillometric upper arm blood pressure monitor HL868ED for clinical use and self-measurement according to the International Protocol of the European Society of Hypertension revision 2010. Method: Systolic and diastolic blood pressure were measured sequentially in 43 adult Chinese (21 women, mean age 51.7 years) using a mercury sphygmomanometer (two observers) and the HL868ED device (one supervisor). A total of 99 pairs of comparisons were obtained from 43 participants for judgements in two parts with three grading phases. Results: The HL868ED device achieved the targets in part 1 of the validation study. The number of absolute differences between device and observers within 5, 10 and 15 mmHg was 68/99, 91/99 and 97/99, respectively, for systolic blood pressure and 85/99, 95/99 and 99/99, respectively, for diastolic blood pressure. The device also fulfilled the criteria in part 2 of the validation study. Twenty-four and 30 participants for systolic and diastolic blood pressure, respectively, had at least two of the three device-observer differences within 5 mmHg (required ≥24). Three participants for systolic and one participant for diastolic blood pressure had all the three device-observer comparisons greater than 5 mmHg. Conclusion: The Health & Life blood pressure monitor HL868ED has passed the requirements of the International Protocol revision 2010 and hence can be recommended for blood pressure measurements in adults. Received 2 July 2019 Accepted 14 September 2019 Supplemental Digital Content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's website, www.bpmonitoring.com. Correspondence to Ji-Guang Wang, MD, PhD, The Shanghai Institute of Hypertension, Ruijin 2nd Road 197, Shanghai 200025, China. Tel: +86 21 64370045 x610911; fax: +86 21 64662193; e-mail: jiguangwang@aim.com Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.
A pilot study of hypertension management using a telemedicine treatment approach
No abstract available
Comparison of a noninvasive 3D force sensor-based method and the invasive arterial cannula in postsurgery intensive care patients: a pilot study
Improvement in sensing technologies is leading to new, accurate noninvasive monitoring devices. However, noninvasive continuous blood pressure (BP) monitoring still faces many challenges, such as: patient's movement, device accuracy and consistency. In this study, the accuracy of a novel noninvasive BP measuring system based on a three-axis force sensor is compared with the invasive arterial cannula taking 21 simultaneous measurements mostly on elderly, postsurgical participants. For the simultaneously recorded invasive and noninvasive signals, the similarity was high, the average correlation was 0.9001 ± 0.0588. The average differences (±SD) for simultaneously recorded systolic, diastolic and mean arterial pressures were: −9.53 ± 4.69, −0.26 ± 3.06 and 1.25 ± 2.26 mmHg, respectively. The results of diastolic and mean arterial pressure satisfy the criteria set by the Association for the Advancement of Medical Instrumentation. These results suggest that this noninvasive system could be a useful tool in continuous noninvasive BP monitoring, but still requires development. All authors approved the current version of the manuscript for publication. Received 5 October 2018 Accepted 13 September 2019 Supplemental Digital Content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's website, www.bpmonitoring.com. Correspondence to Sándor Földi, MS, Faculty of Information Technology and Bionics, Pázmány Péter Catholic University, Budapest, Hungary Tel: +36 1 886 4771; fax: +36 1 886 4724; e-mail: foldi.sandor@itk.ppke.hu Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.
Validation of the InBody BP170 oscillometric home blood pressure monitor in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard
Objective To evaluate the accuracy of the InBody BP170 oscillometric upper-arm home blood pressure (BP) monitor in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018). Methods Subjects were recruited to fulfill the age, gender, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in general population using the same arm sequential BP measurement method. Two cuffs of the test device were used for arm circumference 22–32 (medium) and 32–42 cm (large). Results One-hundred five subjects were recruited and 88 were analyzed. For validation Criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 0.9 ± 6.9/0.5 ± 5.5 mmHg (systolic/diastolic). For Criterion 2, the SD of the averaged BP differences between the test device and reference BP per subject was 5.77/4.80 mmHg (systolic/diastolic). Conclusion The InBody BP170 oscillometric home BP monitor fulfilled all the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) in general population and can be recommended for clinical use. Received 27 August 2019 Accepted 13 September 2019 Correspondence to Professor George S. Stergiou, MD, FRCP, Hypertension Center STRIDE-7, National and Kapodistrian University of Athens, School of Medicine, Third Department of Medicine, Sotiria Hospital, 152 Mesogion Avenue, Athens 11527, Greece Tel: +30 2107763117; fax: +30 2107719981; e-mail: gstergi@med.uoa.gr Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.
Comparison of two blood pressure oscillometric devices: Datascope Accutorr Plus and Mobil-O-Graph PWA and conversion of blood pressure values from one device to the other
Objective This study aims to compare two oscillometric devices used in national health surveys in Germany, Datascope Accutorr Plus and Mobil-O-Graph PWA and to develop formulas for the conversion of blood pressure (BP) values. Methods One hundred and four adults aged 21–86 years had nine alternate same-arm BP measurements according to the International Protocol revision 2010 for the validation of BP measuring devices in adults of the European Society of Hypertension. Measurements 2–8 yielded six pairs of measurements at 30- to 60-second interval with the two devices, totaling 743 pairs used for analysis. Results Mean Mobil-O-Graph SBP and DBP were higher than those from Datascope. Mean differences (Mobil-O-Graph minus Datascope) increased within BP ranges (optimal, normal, high normal, hypertensive stage 1, stage 2 and stage 3): SBP 0.5 ± 8.5, 3.1 ± 8.2, 3.7 ± 8.0, 5.3 ± 8.8, 13.8 ± 10.2 and 15.0 ± 25.9, respectively, and DBP 2.6 ± 5.6, 6.0 ± 4.9, 6.6 ± 5.2, 8.4 ± 4.8, 12.3 ± 4.6 and 20.4 ± 4.2, respectively. For Mobil-O-Graph pulse pressure less than 43 mm Hg, the DBP difference was 6.3 ± 5.5, and for Mobil-O-Graph pulse pressure more than 50 mm Hg, the SBP difference was 7.4 ± 9.3. The prevalence of BP at least 140/90 mm Hg was 28.8% with Mobil-O-Graph and 20.5% with Datascope. Bidirectional conversion models of SBP and DBP adjusting for BP, pulse pressure, sex, age and cuff width to arm circumference ratio were developed. Conclusion The disagreement in oscillometric devices can reach a magnitude that can be relevant for clinical and epidemiological contexts. The here generated conversion formulas may help to improve comparability. Received 12 June 2019 Accepted 13 September 2019 Correspondence to Giselle Sarganas, MScIH, Department of Epidemiology and Health Monitoring, Robert Koch Institute, General-Pape-Str. 62-66, 12101 Berlin, Germany Tel: +49 30 187543340; e-mail: sarganas-margolisg@rki.de Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.
Comparison of the effects of two different teaching methods in blood pressure measurement training: a randomized controlled study
Objective: To compare the effects of a high-fidelity simulator and conventional teaching model used during blood pressure measurement training on students’ self-confidence, self-efficacy and anxiety levels. Methods: A randomized controlled trial design was used. The study was conducted on 59 first-year nursing students of a university in Amasya, Turkey. ‘Self-Confidence Scale,’ ‘general Self-Efficacy Scale’ and ‘Beck Anxiety Scale’ were used to collect the data. A high-fidelity simulator used in blood pressure measurement training was applied to the experimental group, while the conventional method in which the students practice on their peers was applied to the control group. Chi-square, Mann–Whitney U test and the Wilcoxon signed-rank test were used to determine the difference between the two groups’ average. Results: No statistically significant difference was found between students’ pre-test and post-test total scores of self-confidence, general self-efficacy and anxiety scales with the high-fidelity simulator and the conventional model (P > 0.05). A significant increase was noted in inner self-confidence and self-efficacy scores of the group working on the high-fidelity simulator (P < 0.05). Conclusions: The high-fidelity simulator was effective on the students’ increased levels of self-confidence and self-efficacy, whereas it was not effective on their anxiety levels. However, this study can also be conducted on a larger sample group using a variety of training methods. Received 8 February 2019 Accepted 23 July 2019 Supplemental Digital Content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal’s website, www.bpmonitoring.com. Correspondence to Banu Terzi, PhD, BSN, Akdeniz University, Faculty of Nursing, Office address: Akdeniz University Dumlupınar Bulvarı, Akdeniz Üniversitesi Yerleşkesi Konyaaltı, Antalya 07070, Turkey Tel: +90 242 2272974; fax: +90 242 3101511; e-mail: banuterzi@akdeniz.edu.tr Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.
The measurement of blood pressure by the linear method compared to the deflation methods differently modifies the pulse oximeter alarm frequency
Background Noninvasive blood-pressure measurement device and pulse oximeter are important for patient monitoring. When these are placed on the same side, cuff inflation sometimes causes measurement failure by pulse oximeter. Objective The present study aimed to compare the pulse oximeter alarm frequency and pulse-wave disappearance duration between noninvasive blood-pressure measurement using the deflation method and that using the linear inflation method. Methods The study included 10 healthy subjects. The cuff for automatic sphygmomanometer was wrapped on one side of the upper arm and for pulse oximeter was attached to the thumb of the same side of upper limbs. Results The alarm frequency was 0 and 26% using the linear inflation and the deflation methods, respectively. Additionally, the pulse-wave disappearance duration was significantly longer using the deflation method than that using the linear inflation method (10.0 ± 1.5 vs 1.7 ± 0.8 s). With the linear inflation method, this duration was or less 3 s. In the deflation method, an excess pressure of 40 mmHg was used, which caused the alarm to turn on. Additionally, the heart rate was found to influence the alarm occurrence during measurement using the deflation method. Conclusion Heart rate may influence alarm occurrence during blood-pressure measurement using the step deflation method. Using the linear inflation method, the risks of alarm occurrence and measurement failure are low, even when the pulse oximeter and blood-pressure measurement cuffs are installed on the same side, suggesting that this method is suitable for clinical use. Received 13 May 2019 Accepted 13 September 2019 Correspondence to Takashi Hitosugi, DMD, PhD, Department of Dental Anesthesiology, Faculty of Dental Science, Kyushu University, 3-1-1 Maidashi, Higashi-ku, Fukuoka 812-8582, Japan Tel: +81 92 642 6480; fax: +81 92 642 6481; e-mail: hitosugi.takashi.724@m.kyushu-u.ac.jp Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.
Validation of the YuWell YE680B upper-arm blood pressure monitor in adults according to the ANSI/AAMI/ISO 81060-2: 2013 standard
Objective: To evaluate the accuracy of the YuWell YE680B oscillometric upper-arm blood pressure monitor for clinic and home blood pressure measurements in adults according to the American National Standards Institute/the Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 standard. Method: Eighty-five subjects (male 46 and female 39) with a mean age of 44.6 years were recruited to fulfill the age, sex, blood pressure, and cuff distribution criteria of the ANSI/AAMI/ISO standard in the general population using the same arm sequential blood pressure measurement method. Two differently-sized cuffs were used for arm circumferences 22–32 cm (medium) and 22–45 cm (large), respectively, for the test device, and for arm circumferences ≤32 cm (standard) and >32 cm (large), respectively, for the mercury sphygmomanometer. Results: A total of 255 comparison pairs were obtained for analysis. For validation criterion 1, the mean ± SD of the differences between the test device and reference systolic/diastolic blood pressure readings was −2.2 ± 7.2/−3.9 ± 5.2 mmHg. For validation criterion 2, the SD of the averaged systolic/diastolic blood pressure differences between the test device and reference blood pressure per subject was 5.70/4.67 mmHg. Conclusion: The automated upper-arm blood pressure monitor YuWell YE680B has passed the requirements of the ANSI/AAMI/ISO81060-2:2013 standard, and hence can be recommended for blood pressure measurement in the general population. Received 30 June 2019 Accepted 14 August 2019 Correspondence to Ji-Guang Wang, MD, PhD, The Shanghai Institute of Hypertension, Ruijin 2nd Road 197, Shanghai 200025, China, Tel: +86 21 64370045 x610911; fax: +86 21 64662193; e-mail: jiguangwang@aim.com Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.

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