Blood Pressure Measurement Using Vitacam
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- SBP criterion 1: Mean difference and standard deviation between cuffless device systolic blood pressure and reference blood pressure measurement.
研究概览
简要总结
The purpose of this clinical investigation is to collect data for the development, testing, and validation of a blood pressure measurement algorithm for a contactless vital signs monitor, Vitacam, according to the ISO 80601-2:2019 standard for validating non-invasive sphygmomanometer, with the intention of disseminating the validation results through a peer-reviewed scientific publication.
详细描述
Vitacam is a Software-as-Medical Device (SaMD) for measuring vital physiological parameters from a video sequence from a face and chest, which uses computer vision techniques and remote photoplethysmography. This study concerns the development and validation of blood pressure measurements using Vitacam according to internationally recognised ISO (the International Organization for Standardization) standards with modifications imposed by cuffless measurements.
Based on these standards, measurements are collected simultaneously using Vitacam from facial videos, and a clinically validated auscultatory sphygmomanometer.
A minimum of 85 subjects are required for an EN ISO 81060-2:2019 + A2:2024 validation study with at least ≥30% of either sex. The SBP readings must be distributed such that ≥ 5% are ≤100 mmHG; ≥ 5% must be ≥ 160 and ≥ 20% is ≥ 140. The DBP readings must be distributed such that ≥ 5% are ≤60 mmHG; ≥ 5% must be ≥ 100 and ≥ 20% is ≥ 85. There must be at least 255 valid paired BP values.
The mean BP difference must be 5 mm/hg or less, and its standard deviations 8 mm/hg or less (criterion 1, section 5.2.4.2, EN ISO 80601-2:2019).
The standard deviation must also not exceed the value specified in Criterion 2 of the ISO standard, related to the mean difference to the reference BP.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older
- •Ability to give informed consent
- •Volunteering for the study
- •Fluent Finnish or English
排除标准
- •Age under 18 years
- •Pregnancy
- •Inability to give informed consent
结局指标
主要结局
SBP criterion 1: Mean difference and standard deviation between cuffless device systolic blood pressure and reference blood pressure measurement.
时间窗: A period of 5-15 minutes during which the blood pressure of the participant is measured 3-8 times using a clinically validated auscultatory sphygmomanometer, while videos are recorded.
The mean BP difference must be 5 mm/hg or less, and its standard deviations 8 mm/hg or less (criterion 1, section 5.2.4.2, EN ISO 80601-2:2019).
DBP criterion 1: Mean difference and standard deviation between cuffless device diastolic blood pressure and reference blood pressure measurement.
时间窗: A period of 5-15 minutes during which the blood pressure of the participant is measured 3-8 times using a clinically validated auscultatory sphygmomanometer, while videos are recorded
The mean BP difference must be 5 mm/hg or less, and its standard deviations 8 mm/hg or less (criterion 1, section 5.2.4.2, EN ISO 80601-2:2019).
次要结局
- Criterion 2: Inter-subject variability of device-reference blood pressure differences(A period of 5-15 minutes during which the blood pressure of the participant is measured 3-8 times using a clinically validated auscultatory sphygmomanometer, while videos are recorded.)