Comparison of outcomes for routine versus American Heart Association-recommended technique for blood pressure measurement (CORRECT BP): a randomised cohort study.

Background: Optimal clinical care, diagnosis and treatment requires accurate blood pressure (BP) values. The primary objective was to compare BP readings taken while adhering to American Heart Association (AHA) guidelines to those typical of routine clinical care. Specifically studied: the combined effect of feet flat on the floor, back supported, and arm supported with cuff at heart level, while adhering to other guideline recommendations.

Statistical considerations for testing automated sphygmomanometers in special patient populations.

The International Standards Organization 81060-2:2018 is the current global Standard for the validation of automated sphygmomanometers. It specifies the requirements for clinical studies on the general population, as well as additional requirements for special populations, which might have physiologic characteristics that affect the accuracy of blood pressure measurements. This paper summarizes the statistical methodology behind the sample size required to test automated sphygmomanometers in these special populations and specifically addresses the pregnant patient population.

Validation of the Aktiia blood pressure cuff for clinical use according to the ANSI/AAMI/ISO 81060-2:2013 protocol.

Objective: Assess the accuracy and precision of the Aktiia initialization oscillometric upper-arm cuff device (Aktiia SA, Neuchâtel, Switzerland) for home blood pressure (BP) monitoring in the general population according to the American National Standards Institute / Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060-2:2013 standard.

Methods: Three trained observers validated BP measurements performed using the Aktiia cuff versus BP measurements performed using a standard mercury sphygmomanometer. Two ISO 81060-2 criteria were used to validate the Aktiia cuff.

Validation of the A&D UM-212BLE monitor according to ISO 81060-2, 2018: a device with clinically important programmability.

Objective: The objective of this report was to describe the validation of the A&D UM-212BLE automated oscillometric sphygmomanometer to the ISO 81060-2, 2018 protocol. The device is specifically designed for enhanced office and out-of-office programmability.

Methods: A combined pediatric ( n  = 35) and adult ( n  = 50) population was studied at Clinmark LLC in Louisville, Colorado, USA.

Validation of the A&D UA-651 Plus/UA-651SL Plus automated sphygmomanometer according to the ISO 81060-2, 2018 and ISO 81060-2 Amendment 1, 2020, which resulted in the currently pending Amendment to Amendment 1.

In 2020 the ANSI/AAMI/ISO published Amendment 1 to the 81060-2 Standard. The purpose was to try to address issues relating to the distribution of subjects with respect to limb size ranges. It also required a new plot showing the limb circumferences on the x-axis and the device minus reference errors on the y-axis (Alpert plot).

Validation of the STEP deflation algorithm of the Midmark IQvitals Zone Vital Signs Monitor: part of a novel clinical ecosystem.

Objectives: Assess the accuracy of the Midmark IQvitals Zone Vital Signs Monitor STEP deflation algorithm according to the ANSI/AAMI/ISO 81060-2 Standard.

Methods: A total of 85 subjects completed the testing protocol. All standard requirements for gender, blood pressure (BP) values, and arm circumferences were met.

Evaluating the impact of motion artifact on noninvasive blood pressure devices.

Most automated sphygmomanometers use oscillometric algorithms. Motion, either patient-based or environmental, will affect the ability of a device to record an accurate blood pressure (BP). Members of the Association for the Advancement of Medical Instrumentation (AAMI) Sphygmomanometer Committee have been studying this problem for more than a decade.

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).

Validation of the Welch Allyn Home blood pressure monitor with professional SureBP algorithm with a special feature of accuracy during involuntary (tremor) patient movement.

Background: Current blood pressure (BP) measurement guidelines recommend certain patient requirements, especially keeping still for 5 min. Some patients cannot comply. My colleagues and I have reported accurate performance of the Welch Allyn SureBP algorithm for BP estimates during voluntary patient motion.

Accurate blood pressure during patient arm movement: the Welch Allyn Connex Spot Monitor's SureBP algorithm.

Background: Current blood pressure (BP) measurement guidelines specify patient requirements, including being still. Some populations of patients cannot comply. A new International Organization for Standards is being developed to test devices that claim tolerance to transport-induced motion artifacts.

Validation of the Welch Allyn Pro BP 2000, a professional-grade inflation-based automated sphygmomanometer with arrhythmia detection in a combined pediatric and adult population by ANSI/AAMI/ISO standard testing.

Objective: The Welch Allyn Pro BP 2000, an automated sphygmomanometer, was subjected to ANSI/AAMI/ISO testing.

Patients And Methods: The protocol used was the same-arm sequential procedure described in the ANSI/AAMI/ISO 2013 Standard. Eight-eight (53 adults and 35 children aged 3-12 years old) patients completed testing successfully.

Accurate blood pressure measuring devices: Influencing users in the 21st century.

Hypertension is now recognized as a major global cause of morbidity and death. All decisions relating to the epidemiology, diagnosis, and management of hypertension are dependent on being able to measure blood pressure accurately. Scientists have developed protocols to assess the accuracy of blood pressure-measuring devices, but little attention has been given to informing users which devices are accurate and inaccurate.

Validation protocols for blood pressure measuring devices in the 21st century.

Blood pressure (BP) is a vital sign and the essential measurement for the diagnosis of hypertension. Therefore, its accurate measurement is a key element for the evaluation of many medical conditions and for the reliable diagnosis and efficient treatment of hypertension. In the last 3 decades prestigious organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on BP Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices.

The Accutension Stetho, an automated auscultatory device to validate automated sphygmomanometer readings in individual patients.

The aim of this report is to describe a new device that can validate, by automated auscultation, individual blood pressure (BP) readings taken by automated sphygmomanometers.The Accutension Stetho utilizes a smartphone application in conjunction with a specially designed stethoscope that interfaces directly into the smartphone via the earphone jack. The Korotkoff sounds are recorded by the application and are analyzed by the operator on the screen of the smartphone simultaneously with the images from the sphygmomanometer screen during BP estimation.

Accuracy of Blood Pressure Measurement Devices in Pregnancy: A Systematic Review of Validation Studies.

The accurate measurement of blood pressure (BP) in pregnancy is essential to guide medical decision making that affects both mother and fetus. The aim of this systematic review was to determine the accuracy of ambulatory, home, and clinic BP measurement devices in pregnant women. We searched Ovid MEDLINE, The Cochrane Library, EMBASE, CINAHL EBSCO, ClinicalTrials.

Medical students and measuring blood pressure: Results from the American Medical Association Blood Pressure Check Challenge.

Blood pressure (BP) measurement is the most common procedure performed in clinical practice. Accurate BP measurement is critical if patient care is to be delivered with the highest quality, as stressed in published guidelines. Physician training in BP measurement is often limited to a brief demonstration during medical school without retraining in residency, fellowship, or clinical practice to maintain skills.

Validation of the Omron HEM-9210T by the ANSI/AAMI/ISO 81060-2: 2013 with two novel cuffs: wide-range and extra-large.

Objective: The aims of this ANSI/AAMI/ISO validation study were to assess the accuracy of the Omron HEM-9210T, developed to utilize a small cuff, a wide-range cuff, and an extra-large cuff in the adult population. If accurate, the wide-range and extra-large cuffs will be of clinical significance in both medical and self-measurement environments.

Methods: Individuals were recruited at an independent clinical research center.

Assessing the accuracy of the OMRON HEM-907XL oscillometric blood pressure measurement device in patients with nondialytic chronic kidney disease.

The OMRON HEM-907XL is a commercial oscillometric blood pressure (BP) monitor that was used in the Systolic Blood Pressure Intervention Trial (SPRINT), in which 28% of participants had chronic kidney disease (CKD). This study examined the accuracy of the monitor in nondialytic patients with CKD. Eighty-seven patients met inclusion criteria.