Clinical Validation of the Wrist Blood Pressure Measuring Device Combei BP 880 W for Home Use According to "the Universal" Standard (AAMI/ESH/ISO)" in the General Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 2
- 主要终点
- Accuracy of blood pressure measurement
研究概览
简要总结
Clinical validation of the wrist blood pressure measuring device Combei BP 880 W for home use according to "the Universal Standard for the validation of blood pressure measuring devices by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO)" in the general population.
详细描述
Members of the AAMI, ESH and ISO committees achieved a consensus on an optimal validation standard and agreed on a single protocol for the validation of BP measuring devices that will replace all previous ones.
Therefore, the Association for the Advancement of Medical Instrumentation / European Society of Hypertension / International Organization for Standardization Universal Standard (AAMI/ESH/ISO 81060-2:2018) is now considered as the standard protocol for the validation of non-invasive blood pressure measuring device.
This study aims to demonstrate that the Combei BP 880 W wrist device fulfills the requirements of the new protocol of clinical validation and its Amendment 1, 2020-01 for limb circumference distribution criteria.
this is a monocentric, prospective, non-randomized, non-interventional, cross-study.
Combei BP 880 W wrist device (Sphygmomanometer Under Test, SUT). The reference device is the mercury sphygmomanometer The primary objective of the study is to assess the accuracy of the automatic oscillometric BP measuring device at the wrist level, the Combei BP 880 W, in the general population, following AAMI/ESH/ISO 81060-2:2018 protocol and its Amendment 1, 2020-01 for limb circumference distribution criteria.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient older than 12 years;
- •Patient who signed the informed consent form;
- •Patient followed-up at site (in-patient or out-patient);
- •Patient with wrist circumference between 12.5 and 21.5 cm*. *in accordance with the Indications For Use of the Combei BP 880 W device.
排除标准
- •Patient unable to give a consent or understand properly protocol information;
- •Patient suffering from arrhythmia;
- •Patient with poor quality of Korotkov sounds;
- •Patient for whom K5 sounds are absent.
结局指标
主要结局
Accuracy of blood pressure measurement
时间窗: Subject will participate to only one session of measurement. The duration of one session is about 45 minutes.
differences \< than 5 +/- 8 mmHg according to the protocol by comparison to the gold standard (mercury sphygmomanometer)
次要结局
- differences between the tested device and the gold standard (mercury sphygmomanometer according to the baseline blood pressure and to the wrist circumference(Subject will participate only one time to the study. one session of blood pressure measurement will be performed. the duration of one session is about 45 minutes)
研究者
Catherine DOGNON HADDAD
Professor Roland Asmar
International Society for Vascular Health