Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 351
- 试验地点
- 8
- 主要终点
- Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL)
研究概览
简要总结
The study is a prospective, non-randomized, non-blinded, non-significant risk, multi-center study enrolling up to 500 healthy adult subjects consented to undergo a whole blood donation procedure. The study will involve enrolling subjects that will undergo blood donation wearing the study device (CM-1600 Device) and capture study-required physiological parameters pre-, during, and post-donation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Ability to provide written consent
- •Ability and willingness to comply with the study procedures and duration requirements
- •18 years of age or older
- •Consented and eligible to undergo a single unit whole blood donation
排除标准
- •Females who are pregnant or breastfeeding
- •Undergone an amputation of any upper extremity
- •Diagnosed with dextrocardia
- •Subjects who have a pacemaker
- •Subjects with body hair density which prevents adequate application of device electrodes
结局指标
主要结局
Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL)
时间窗: Recovery period following donation (10 minutes)
The objective of this study is to determine if manual blood loss of up to 500mL of blood can be identified using the non-invasive Zynex CM-1600. This will be measured by determining the percent change in Relative Index (RI) before and after the Blood Draw. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set minimum or maximum, where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline.
次要结局
未报告次要终点