VicorderCS NIBP Validation Study to Assess Its Ability to Capture Blood Pressure Measurements
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Blood Pressure
研究概览
简要总结
80 Beats Medical introduces the VicorderCS, the next generation of our Vicorder technology designed to manage hypertension and cardiovascular risks. This advanced diagnostic equipment offers non-invasive collection and computation of a plethora of cardiovascular markers. It is faster, easier to use, and more portable than its predecessor, with enhanced connectivity options for extended marker collection and analysis. These markers enable early diagnosis of cardiovascular disease, ensuring positive patient outcomes. With a strong foundation in numerous published clinical studies, the VicorderCS enhances data collection and analysis capabilities, empowering the research community in developing new drugs and therapeutics. This validation study is purposed to evaluate one of the physiological parameters that is measured by the VicorderCS system, which is Non-invasive Blood Pressure (NIBP) via the common oscillometric cuff-based method.
详细描述
The VicorderCS will enable medical personnel to conduct Blood Pressure measurement procedures for the evaluation of a participant's cardiovascular health.
Clinical Rationale This study will compare the accuracy of the 80 Beats Medical noninvasive blood pressure measurement using the VicorderCS device with that of human observers' readings using the auscultatory method, as required by the applicable ISO standard: Non-invasive sphygmomanometers part 2 - clinical investigation of intermittent automated measurement type1. The study will aim to enroll 120 participants for blood pressure readings using both the VicorderCS and auscultatory method using a calibrated aneroid sphygmomanometer.
Design Rationale The VicorderCS blood pressure study will be conducted using consenting participants in Summit County Colorado and designed to be compliant with the requirements within the applicable ISO standard1. Study data, including systolic and diastolic blood pressure readings, will be collected using both the VicorderCS and auscultatory method using a sphygmo-manometer.
Proposed Solution 80 Beats Medical has developed the VicorderCS, which is indicated for the non-invasive measurement of blood pressure to detect cardiovascular health risks.
Device Description
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 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
- 否
入选标准
- •Any gender, in good general health
- •Must be 18 years old or older, inclusive at enrollment
- •Must be willing to provide blood pressure measurement
- •Must be able to read, understand, and willingly sign an Informed Consent Form
- •Must be able to read, speak and understand English
- •Must be available to attend one study visit at: please specify exact location.
排除标准
- •Excluding subjects with significantly irregular heart rhythm (e.g. Bigeminy, trigeminy, isolated ventricular premature beat (VPB), atrial fibrillation) or are pregnant
- •No active email address
- •Non-English or Spanish- speaking
- •Unable to read in English.
研究组 & 干预措施
Cross-Sectional Group
Blood pressure reading of one group of participants
干预措施: VicorderCS (Device)
结局指标
主要结局
Blood Pressure
时间窗: 1 Day
A mean difference was measured between the VicorderCS noninvasive blood pressure measurement method and the auscultation method using a Korotkoff sounds device with human observers' readings.
次要结局
未报告次要终点