Study Focus: Blood Pressure Measures, Volunteers
Conditions
Keywords
blood pressure, iso 81060-2, upper arm blood pressure monitor, commercialized device validation
Brief summary
Prospective, single-center, single-arm, open, comparative, validation of a commercialized device, repeated measures accuracy study designed in accordance with the requirements of the ISO 81060-2:2018 AAMI/ESH/ISO Universal Standard for the clinical validation of automated non-invasive sphygmomanometers (Non-invasive sphygmomano-meters - Part 2: Clinical investigation of intermittent automated measurement, including Amendments 1 and 2)). The validation will be conducted with volunteers rather than necessarily with patients, and all measurements will be performed outside of the subjects' normal diagnosis or treatment.
Interventions
DIAGNOSTIC_TESTBlood pressure measurement
All measurements will be performed by trained observers in line with the requirements of the ISO 81060-2:2018 AAMI/ESH/ISO Universal Standard (1), ensuring accuracy, consistency, and reproducibility. The investigation shall be performed in an isolated room under comfortable ambient temperature. * The cuff shall be applied on the bare arm with no compression proximal to the cuff. * The subject shall rest quietly for at least 10 minutes prior to the start of measurements. * The subject should avoid talking during the entire measurement procedure. * BP shall be measured on the subject's left arm at heart level. * A minimum of 5 minutes shall elapse prior to obtaining the first reference blood pressure measurement.
Sponsors
European Cardiovascular Research Center
B.Well Swiss AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective, single-center, single-arm, open, comparative, validation of a commercialized device, with repeated measures accuracy study designed in accordance with the requirements of the ISO 81060-2:2018 AAMI/ESH/ISO Universal Standard for the clinical validation of automated non-invasive sphygmomanometers (Non-invasive sphygmomano-meters - Part 2: Clinical investigation of intermittent automated measurement, including Amendments 1 and 2)). The study aims to clinically evaluate the accuracy of the B-Well PRO-25 upper arm automated sphygmomanometer for systolic blood pressure (SBP) and diastolic blood pressure (DBP) in adults and adolescents in accordance with ISO 81060-2. The comparative measurements are obtained through auscultation by an observer using a mercury sphygmomanometer (reference method).
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age \> 12 years * Signed Informed Consent
Exclusion criteria
* Any medical condition preventing light to moderate arm compression * Absence of the upper arm * Subjects with upper arm circumference \<22 cm or \>42 cm * Subjects with severe shock; * Subjects with a history of mental illness or current mental disorders; * Patients with arrhythmias (atrial premature beats, ventricular premature beats, atrial fibrillation, etc.) or upper limb arteriosclerosis (at the direct measurement site); * Subjects using extracorporeal circulation devices; * Subjects with excessive limb asymmetry; * Subjects who have undergone mastectomy or lymph node dissection; * Subjects with arm injuries or exposed wounds, or those with circulatory disorders; * Subjects with vascular accesses in the arms or arteriovenous shunt tubes; * Subjects who have participated in other clinical trials within the past 1 month; * Subjects for whom the procedures during the clinical trial may pose excessive medical risks; * Subjects determined by the investigator to be unsuitable for participating in the clinical study. * Subject under judicial protection, guardianship or curatorship or participant deprived of their liberty by judicial or administrative decision
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The study will assess compliance with the following validation criteria defined by the standard ISO 81060-2:2018: Criterion 1 - Group-level accuracy (paired-difference analysis). Criterion 2 - Subject-level accuracy | Day 1 | The study will assess compliance with the following validation criteria defined by the standard ISO 81060-2:2018 for SBP and DBP (in mmHg): Criterion 1 - Group-level accuracy (paired-difference analysis). For systolic blood pressure (SBP) and diastolic blood pressure (DBP) separately, the mean difference between the test device and the reference method (observer auscultation with a mercury sphygmomanometer) across all valid paired determinations shall be within ±5 mmHg, and the standard deviation (SD) of these differences shall be ≤ 8 mmHg. Criterion 2 - Subject-level accuracy For SBP and DBP, each subject's mean difference (test device - reference) shall be calculated from that subject's repeated paired determinations. The standard deviation of these subject-level means across all subjects shall comply with the requirements specified in Table 1 Averaged subject data acceptance in mmHg of ISO 81060-2:2018 (1) for SBP and DBP. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Population characteristics- Age | Day 1 | Age (descriptive summary) |
| Population Characteristics - Sex | day 1 | Sex (descriptive summaries) |
| Agreement by Bland-Altman analysis | Day 1 | Calculation of the bias (average difference between test device and reference method) and the 95% limits of agreement (LoA) for systolic blood pressure (SBP) and diastolic blood pressure (DBP), overall and across the blood pressure range |
| Population Characteristics- baseline blood pressure categories | Day 1 | Normotensive/hypertensive ranges for both systolic and diastolic pressures |
| Observser agreement | Day 1 | percentage of paired measurements (within +/- 4 mmHg) |
| Population Characteristics- arm circumferences | Day 1 | arm circumferences (descriptive summaries) |
Contacts
Primary ContactThomas Fassler Fassler
Outcome results
None listed