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Blood Pressure Monitoring Aug 2024We aimed to validate the accuracy of the Mindray VS9 Vital Signs Monitor, which features the Mindray TrueBP inflation algorithm for oscillometric blood pressure (BP)...
We aimed to validate the accuracy of the Mindray VS9 Vital Signs Monitor, which features the Mindray TrueBP inflation algorithm for oscillometric blood pressure (BP) measurement, to check if it complies with the International Organization for Standardization Standard (ISO 81060-2:2018) in a combined adult and pediatric population. A total of 86 participants, including both adult and pediatric subjects, were recruited. The distribution of their ages, gender, BPs and limb sizes all complied with the requirement of the ISO standard. The inflation and deflation algorithms were validated independently using the same-arm sequential BP measurement method. For each subject, the BP was first determined by two independent observers using a mercury sphygmomanometer (R1). The BP of the subject was then determined by the third observer using the test equipment (T1). Then, using a mercury sphygmomanometer, two independent observers were asked to determine the subject's BP (R2) again. R1-T1-R2 were considered a valid pair of data. This cycle continued until 3 pairs of valid data were achieved. We collected 258 pairs of valid BP data for the validation of the inflation and deflation algorithms respectively. For validation Criterion 1, the mean ± SD of the differences between the readings obtained from the test device and reference BP was 0.0 ± 6.6/-1.8 ± 7.1 mmHg (systolic/diastolic) when the deflation algorithm was used, and 2.4 ± 6.3/ 0.3 ± 6.9 mmHg (systolic/diastolic) when the inflation algorithm was used. For validation Criterion 2, the SD of the averaged BP differences between the test device and the reference BP per subject was 5.35/6.33 mmHg (systolic/diastolic) when the deflation algorithm was used, and 5.17/5.75 mmHg (systolic/diastolic) when the inflation algorithm was used. The VS9 Vital Signs Monitor fulfilled all the criteria in the ISO Standard. Moreover, the inflation algorithm had a shorter Measure Time (by 7-21 s) and lower maximum inflation pressure (by 9.7-22 mmHg). The VS9 Vital Signs Monitor fulfilled all the requirements of the ISO Standard (ISO 81060-2:2018) in a combined adult and pediatric population and is recommended for clinical use.
Topics: Humans; Adult; Male; Female; Child; Adolescent; Middle Aged; Blood Pressure Determination; Algorithms; Aged; Blood Pressure; Blood Pressure Monitors; Young Adult
PubMed: 38523458
DOI: 10.1097/MBP.0000000000000704 -
Archivos de Cardiologia de Mexico 2024Virtual consultations have increased exponentially, but a limitation is the inability to assess vital signs (VS). This is particularly useful in patients with heart...
BACKGROUND
Virtual consultations have increased exponentially, but a limitation is the inability to assess vital signs (VS). This is particularly useful in patients with heart failure (HF) for titrating prognosis-modifying medication. This issue could potentially be addressed by a tool capable of measuring blood pressure (BP) and heart rate (HR) accurately, remotely, and conveniently. Mobile phones equipped with transdermal optical imaging technology could meet these requirements.
OBJECTIVE
To evaluate the accuracy of a transdermal optical imaging-based app for estimating VS compared to clinical assessment in patients with HF.
METHODS
A prospective cohort study included patients evaluated in an HF outpatient unit between February and April 2022. BP and HR were simultaneously assessed using the app and clinical examination (BP with an automated sphygmomanometer and HR by brachial palpation). Three measurements were taken by both the app and clinic for each patient, by two independent blinded physicians.
RESULTS
Thirty patients were included, with 540 measurements of BP and HR. The mean age was 66 (± 13) years, 53.3% were male. The mean left ventricular ejection fraction was 37 ± 15, with 63.3% having previous hospitalizations for HF, and 63.4% in NYHA class II-III. The mean difference between the app measurement and its clinical reference measurement was 3.6 ± 0.5 mmHg for systolic BP (SBP), 0.9 ± -0.2 mmHg for diastolic BP (DBP), and 0.2 ± 0.4 bpm for HR. When averaging the paired mean differences for each patient, the mean across the 30 patients was 2 ± 6 mmHg for SBP, -0.14 ± 4.6 mmHg for DBP, and 0.23 ± 4 bpm for HR.
CONCLUSION
The estimation of BP and HR by an app with transdermal optical imaging technology was comparable to non-invasive measurement in patients with HF and met the precision criteria for BP measurement in this preliminary study. The use of this new transdermal optical imaging technology provides promising data, which should be corroborated in larger cohorts.
Topics: Humans; Male; Aged; Female; Mobile Applications; Stroke Volume; Prospective Studies; Ventricular Function, Left; Heart Failure; Blood Pressure
PubMed: 38507315
DOI: 10.24875/ACM.22000221 -
JMIR Research Protocols Mar 2024Children with mobility disabilities, including those with cerebral palsy, have limited options and limited time to exercise to manage their cardiometabolic health and...
Telehealth Movement-to-Music With Arm-Based Sprint-Intensity Interval Training to Improve Cardiometabolic Health and Cardiorespiratory Fitness in Children With Cerebral Palsy: Protocol for a Pilot Randomized Controlled Trial.
BACKGROUND
Children with mobility disabilities, including those with cerebral palsy, have limited options and limited time to exercise to manage their cardiometabolic health and cardiorespiratory fitness. Regular cardiovascular exercise during childhood is a critical health behavior for preventing health decline in adulthood. Thus, there is an urgent need for accessible, age-appropriate, convenient exercise modalities in this group. Sprint-intensity interval training (SIT), combined with telehealth procedures, may be ideal for children with disabilities. SIT includes repetitive bouts of maximal exercise effort combined with rest periods, which can be effective in eliciting comparable results to moderate-exercise training with very short training durations.
OBJECTIVE
This phase 1 pilot feasibility randomized controlled trial aims to investigate the potential effects of a 12-week SIT program on indicators of cardiorespiratory fitness and cardiometabolic health among children with cerebral palsy. An ancillary aim is to evaluate the feasibility of the program through several process feasibility metrics.
METHODS
This study uses a 2-armed parallel group design. A total of 50 physically inactive children with cerebral palsy (aged 6-17 years) will be randomly allocated into 1 of 2 groups: a 12-week SIT or a waitlist control group that continues habitual activity for 12 weeks. The SIT prescription includes 3 tele-supervised sessions per week with 30 repeated sequences of 4 seconds of maximal arm exercise, with active recovery, warm-up, and cooldown periods (for an approximately 20-minute total session). SIT includes guided videos with child-themed arm routines and music. The exercise sessions will be remotely supervised through a web-based videoconference application and include safety monitoring equipment. Outcomes are measured at pre- and postintervention (weeks 0 and 13, respectively). Health outcome measures include peak oxygen consumption (VO peak), measured by a graded exercise test; high-sensitivity C-reactive protein and blood insulin, hemoglobin A, triglycerides, and cholesterol using a finger stick dried blood spot test; blood pressure, using a sphygmomanometer; and body composition (total mass, total lean mass, tissue % lean, and tissue % fat) using dual x-ray absorptiometry. Feasibility will be evaluated by the following metrics: adverse events or problems experienced throughout the intervention related to participant safety; perceived enjoyment; and recruitment, enrollment, and attrition rates.
RESULTS
Recruitment procedures started in November 2023. All data are anticipated to be collected by February 2025. Full trial results are anticipated to be analyzed and submitted for publication by March 2025. Secondary analyses of data will be subsequently published.
CONCLUSIONS
This trial tests an accessible and low-cost exercise program that leverages principles of high-intensity exercise to provide a convenient program for children with physical disabilities. Knowledge obtained from this study will inform the development of a larger trial for improving the cardiometabolic health, cardiorespiratory fitness, and well-being of children with physical disabilities.
TRIAL REGISTRATION
ClinicalTrials.gov NCT05619211; https://clinicaltrials.gov/study/NCT05619211.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
DERR1-10.2196/56499.
PubMed: 38441939
DOI: 10.2196/56499 -
Blood Pressure Monitoring Jun 2024The aim of this study was to evaluate the accuracy of the Raycome model M2 oscillometric upper-arm blood pressure (BP) monitor developed for ambulatory BP measurement in... (Clinical Trial)
Clinical Trial
Validation of the Raycome model M2 ambulatory blood pressure monitor in the general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization Universal Standard (ISO 81060-2:2018).
OBJECTIVE
The aim of this study was to evaluate the accuracy of the Raycome model M2 oscillometric upper-arm blood pressure (BP) monitor developed for ambulatory BP measurement in the 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) at rest and during dynamic exercise.
METHOD
Subjects were recruited to fulfill the age, gender, BP and cuff distribution criteria of the AAMI/ESH/ISO Universal Standard in the general population using the same arm sequential BP measurement method. Three cuffs of the test device were used for arm circumference 18-22 cm (small), 22-32 cm (medium) and 32-42 cm (large).
RESULTS
For the general validation study, 106 subjects were recruited and 85 were analyzed. For validation criterion 1, the mean ± SD of the differences between the test device and reference BP readings was 0.5 ± 6.2/-0.2 ± 5.1 mmHg (systolic/diastolic). For criterion 2, the SD of the mean BP differences between the test device and reference BP per subject was 5.23/4.50 mmHg (systolic/diastolic). In the ambulatory validation study ( N = 35), the mean difference was 0.4 ± 5.9/-1.1 ± 5.8 mmHg. The Raycome model M2 performed well against the standard in both the general and ambulatory validations and the Bland-Altman plots did not show any systematic variation in the error.
CONCLUSION
These data show that the Raycome model M2 monitor meets the requirements of the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018) and in the ambulatory setting, indicating its suitability for measuring BP in the general population.
Topics: Humans; Blood Pressure Monitoring, Ambulatory; Male; Female; Middle Aged; Adult; Aged; Blood Pressure Monitors; Hypertension; Blood Pressure
PubMed: 38390625
DOI: 10.1097/MBP.0000000000000697 -
Clinical and Experimental Hypertension... Dec 2024The objective was to utilize a smartwatch sphygmomanometer to predict new-onset hypertension within a short-term follow-up among individuals with high-normal blood...
OBJECTIVES
The objective was to utilize a smartwatch sphygmomanometer to predict new-onset hypertension within a short-term follow-up among individuals with high-normal blood pressure (HNBP).
METHODS
This study consisted of 3180 participants in the training set and 1000 participants in the validation set. Participants underwent both ambulatory blood pressure monitoring (ABPM) and home blood pressure monitoring (HBPM) using a smartwatch sphygmomanometer. Multivariable Cox regressions were used to analyze cumulative events. A nomogram was constructed to predict new-onset hypertension. Discrimination and calibration were assessed using the C-index and calibration curve, respectively.
RESULTS
Among the 3180 individuals with HNBP in the training set, 693 (21.8%) developed new-onset hypertension within a 6-month period. The nomogram for predicting new-onset hypertension had a C-index of 0.854 (95% CI, 0.843-0.867). The calibration curve demonstrated good agreement between the nomogram's predicted probabilities and actual observations for short-term new-onset hypertension. In the validate dataset, during the 6-month follow-up, the nomogram had a good C-index of 0.917 (95% CI, 0.904-0.930) and a good calibration curve. As the score increased, the risk of new-onset hypertension significantly increased, with an HR of 8.415 (95% CI: 5.153-13.744, = .000) for the middle-score vs. low-score groups and 86.824 (95% CI: 55.071-136.885, = .000) for the high-score vs. low-score group.
CONCLUSIONS
This study provides evidence for the use of smartwatch sphygmomanometer to monitor blood pressure in individuals at high risk of developing new-onset hypertension in the near future.
TRIAL REGISTRATION
ChiCTR2200057354.
Topics: Humans; Blood Pressure; Cohort Studies; Blood Pressure Monitoring, Ambulatory; Hypertension; Sphygmomanometers; Nomograms
PubMed: 38346228
DOI: 10.1080/10641963.2024.2304023 -
BMJ Open Feb 2024To quantify the trends in systolic and diastolic blood pressure (BP) among adults in Shenzhen from 1997 to 2018.
OBJECTIVE
To quantify the trends in systolic and diastolic blood pressure (BP) among adults in Shenzhen from 1997 to 2018.
DESIGN
Cross-sectional study.
SETTINGS
The data were collected from all districts in Shenzhen, China in the years of 1997, 2009 and 2018 by multistage cluster sampling procedure.
PARTICIPANTS
Participants were residents aged 18-69 years in Shenzhen, China. A total of 26 621 people were included: 8266 people in 1997, 8599 people in 2009 and 9756 people in 2018.
PRIMARY AND SECONDARY OUTCOME MEASURES
All participants were surveyed about their sociodemographic and lifestyle information. BP was measured by trained physicians using a mercury sphygmomanometer. Hypertension was defined as systolic BP of at least 140 mm Hg and diastolic BP of at least 90 mm Hg, self-reported use of antihypertensive medications or both. Hypertension control was defined as systolic BP values of less than 140 mm Hg and diastolic BP values of less than 90 mm Hg.
RESULT
Age-adjusted mean systolic BP increased from 117±16 mm Hg to 123±15 mm Hg (p<0.001) in males, and from 113±18 mm Hg to 115±16 mm Hg (p<0.001) in females from 1997 to 2018. Diastolic BP among males increased from 75 mm Hg (SD=11) to 79 mm Hg (SD=11) and increased from 71 mm Hg (SD=10) to 73 mm Hg (SD=10) among females between 1997 and 2018 (p<0.001). Rate of hypertension rose rapidly from 17.71% (95% CI: 16.60% to 18.90%) in 2009 to 24.01% (95% CI: 22.84% to 25.22%) in 2018 among males (p<0.001), whereas the prevalence among females remained stable at around 13.5% (p=0.98). Both awareness and treatment rates of hypertension among males and females showed a decreased trend between 2009 and 2018, while no significant changes were observed for control rates.
CONCLUSIONS
The mean systolic BP and diastolic BP among adults in Shenzhen increased from 1997 to 2018, and no improvements in hypertension awareness, treatment and control rates were found.
Topics: Adult; Male; Female; Humans; Blood Pressure; Cross-Sectional Studies; Hypertension; Antihypertensive Agents; China
PubMed: 38341201
DOI: 10.1136/bmjopen-2023-074575 -
Journal of the International AIDS... Feb 2024Dolutegravir (DTG) is widely used for antiretroviral therapy (ART). We compared weight and blood pressure trends and examined the association between high blood pressure...
INTRODUCTION
Dolutegravir (DTG) is widely used for antiretroviral therapy (ART). We compared weight and blood pressure trends and examined the association between high blood pressure and weight gain among people living with HIV (PLHIV) switching to or starting DTG-based, efavirenz (EFV)-based and ritonavir-boosted atazanavir (ATV/r)-based ART in Zimbabwe.
METHODS
PLHIV aged 18 years or older who started or switched to DTG, EFV or ATV/r-based ART between January 2004 and June 2022 at Newlands Clinic in Harare, Zimbabwe, were eligible. Weight was measured at all visits (Seca floor scales); blood pressure only at clinician-led visits (Omron M2 sphygmomanometer). We used Bayesian additive models to estimate trends in weight gain and the proportion with high blood pressure (systolic >140 mmHg or diastolic >90 mmHg) in the first 2 years after starting or switching the regimen. Finally, we examined whether trends in the proportion with high blood pressure were related to weight change.
RESULTS
We analysed 99,969 weight and 35,449 blood pressure records from 9487 adults (DTG: 4593; EFV: 3599; ATV/r: 1295). At 24 months after starting or switching to DTG, estimated median weight gains were 4.54 kg (90% credibility interval 3.88-5.28 kg) in women and 3.71 kg (3.07-4.45 kg) in men, around twice that observed for ATV/r and over four-times the gain observed for EFV. Prevalence of high blood pressure among PLHIV receiving DTG-based ART increased from around 5% at baseline to over 20% at 24 months, with no change in PLHIV receiving EFV- or ATV/r-based ART. High blood pressure in PLHIV switching to DTG was associated with weight gain, with stronger increases in the proportion with high blood pressure for larger weight gains.
CONCLUSIONS
Among PLHIV starting ART or switching to a new regimen, DTG-based ART was associated with larger weight gains and a substantial increase in the prevalence of high blood pressure. Routine weight and blood pressure measurement and interventions to lower blood pressure could benefit PLHIV on DTG-based ART. Further studies are needed to elucidate the mechanisms and reversibility of these changes after discontinuation of DTG.
Topics: Adult; Male; Humans; Female; HIV Infections; Longitudinal Studies; Atazanavir Sulfate; Blood Pressure; Zimbabwe; Bayes Theorem; Benzoxazines; Heterocyclic Compounds, 3-Ring; Hypertension; Weight Gain; Body Weight; Anti-HIV Agents; Piperazines; Pyridones; Alkynes; Oxazines; Cyclopropanes
PubMed: 38332525
DOI: 10.1002/jia2.26216 -
Cureus Jan 2024Hypertension is a major risk factor for coronary artery disease. Due to the increased accessibility of smartphones over the past decade, there has been an increase in...
BACKGROUND
Hypertension is a major risk factor for coronary artery disease. Due to the increased accessibility of smartphones over the past decade, there has been an increase in the screen time of adolescents and young adults. However, the relationship between screen time and hypertension has not been adequately studied. Our study aims to find a correlation between screen time and blood pressure (BP) among young adults.
METHODS
A cross-sectional analysis was performed on a sample of medical students (n = 210) from New Delhi, India. Participants' screen time was monitored over three weeks and BP was recorded using a standardized sphygmomanometer by auscultatory method. Exclusion criteria included known cases of hypertension (with or without ongoing treatment), smokers > five pack year, heavy alcoholics, and participants having sleep time of less than seven hours or more than nine hours per day. Screen time was correlated with BP readings using standard statistical methods.
RESULTS
Participants with screen time >390 minutes (six hours and 30 minutes), >420 minutes (seven hours), and >480 minutes (eight hours) had higher odds of elevated BP (OR: 1.86, 95% CI: 1.05-3.30; OR: 1.86, 95% CI: 1.04-3.30; OR: 1.87, 95% CI: 1.02-3.43, respectively) compared to students with screen time <390 minutes. The findings were consistent after excluding participants with high BMI based on the WHO and Asia-Pacific criteria, which also showed higher odds of elevated BP with screen time >390 minutes (OR: 3.21, 95% CI: 1.58-6.49 and OR: 3.92, 95% CI: 1.49-10.31, respectively). Regression analysis showed no significant linear correlation between screen time and BP (p > 0.05). However, a significant association was observed between BMI and elevated BP (p < 0.001).
CONCLUSION
This study revealed an association exists between screen time and BP.
PubMed: 38313899
DOI: 10.7759/cureus.51667 -
Journal of Hypertension Apr 2024There is an increasing number of cuffless blood pressure (BP) measurement (BPM) devices. Despite promising results when comparing single measurements, the ability of...
OBJECTIVE
There is an increasing number of cuffless blood pressure (BP) measurement (BPM) devices. Despite promising results when comparing single measurements, the ability of these devices to track changes in BP levels over 24 h related to an initial calibration BP (CalibBP) is unknown. Our aim was to analyse this ability in a cuffless device using pulse transit time.
METHODS
We prospectively enrolled 166 participants for simultaneously performed cuffless (Somnotouch-NIBP) and cuff-based (Spacelabs 90217A/IEM Mobil-O-graph) 24 h BPM. As CalibBP for the cuffless device, first cuff-based BP was used. As surrogate for changes in BP levels after the CalibBP, we used the difference between the CalibBP and mean 24 h, awake and asleep BP measured by the two devices. In addition, we analysed the relationship between the difference of the CalibBP and the cuff-based BPM versus the difference between the cuff-based and the cuffless BPM devices.
RESULTS
Mean(SD) difference between the CalibBP and mean 24hBP by the cuff-based or cuffless BP device were 7.4 (13.2) versus 1.8 (8.3) mmHg for systolic ( P < 0.0001) and 6.6 (6.8) versus 1.6 (5.8) mmHg for diastolic ( P < 0.0001). A near linear relationship was seen among the difference between the CalibBP and the cuff-based BPM values and the difference between the cuff-based and cuffless BPM device.
CONCLUSION
Our data indicate a lower ability of the cuffless BPM device to track changes of BP levels after CalibBP. In addition, cuffless device accuracy was associated with the changes in BP levels after the initial CalibBP - the larger the BP level change, the larger the difference between the devices.
REGISTRATION
https://www.clinicaltrials.gov ; Unique identifier: NCT03054688; NCT03975582.
Topics: Humans; Blood Pressure; Blood Pressure Determination; Blood Pressure Monitoring, Ambulatory; Sphygmomanometers; Arterial Pressure
PubMed: 38288945
DOI: 10.1097/HJH.0000000000003667 -
Frontiers in Cardiovascular Medicine 2023Mercury sphygmomanometer (MS) has now been less and less used and no new devices have been manufactured (according to Minamata convention 2013). The application of the...
OBJECTIVE
Mercury sphygmomanometer (MS) has now been less and less used and no new devices have been manufactured (according to Minamata convention 2013). The application of the electronic sphygmomanometer (ES) in clinical practice has become increasingly common. However, reliable evidence for the use of the ES in high-altitude areas remains scarce. The purpose of this study was to validate the applicability of the ES in high altitude areas.
METHODS
In Luhuo County, Sichuan Province, China, 3,400 m above the sea level, two trained physicians measured the blood pressure (BP) of participants using both the mercury sphygmomanometer and the ES. Pearson correlation analysis and paired T-test, respectively, were used to compare the correlation and the difference between the BP values measured by the two devices. The applicability of the ES in high-altitude areas was evaluated according to the validation standards of the 2018 Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement.
RESULTS
In this study, 257 participants were included. There was a strong correlation between BP values measured by the two devices, with correlation coefficients for systolic blood pressure (SBP) and diastolic blood pressure (DBP) of 0.97 and 0.93, respectively. Compared with the MS, the ES tended to measure the subjects' DBP (76.21 ± 13.29 mmHg vs. 76.53 ± 14.07 mmHg; = 0.557) accurately, but overestimate the SBP of the subjects (123.32 ± 22.25 mmHg vs. 121.34 ± 22.88 mmHg; < 0.001) to some extent. The consistency of the two devices in the classification of normal BP, prehypertension, and hypertension was 88.9%, 80.7%, and 89.2%, respectively.
CONCLUSIONS
In general, the utilization of ES at 3,400 m altitude successfully met the validation standards of the AAMI/ESH/ISO Collaboration Statement. The use of ES can be recommended at a high altitude, including up to 3,400 m. In addition, because the ES tended to overestimate SBP, we speculate that it may need to be calibrated in high-altitude areas.
PubMed: 38259316
DOI: 10.3389/fcvm.2023.1257444