Validation of the B. Well Digital Upper Arm Blood Pressure Monitor Pro-25 According to ISO 81060- 2
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 12 years
- •Signed Informed Consent
排除标准
- •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
结局指标
主要结局
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
时间窗: 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.
次要结局
- Agreement by Bland-Altman analysis(Day 1)
- Population characteristics- Age(Day 1)
- Population Characteristics - Sex(day 1)
- Population Characteristics- arm circumferences(Day 1)
- Population Characteristics- baseline blood pressure categories(Day 1)
- Observser agreement(Day 1)