Evaluation of Physiological Variables and Detection of Blood Loss in Healthy Adults With Different Subject Positioning by the Zynex Cardiac Monitor, Model 1500 (CM-1500)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Impact of Subject Positioning on Percent Change of Heart Rate (HR) 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 study enrolling up to 60 healthy adult subjects consented to undergo a 1-unit whole blood draw procedure. Subjects will wear the study device (CM-1500) while positioned in either a supine or reclined position during the blood draw and study-required physiological parameters will be captured pre-, during, and post-donation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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 informed 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
Impact of Subject Positioning on Percent Change of Heart Rate (HR) 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 affects heart rate. This will be measured by determining the percent change in HR before and after the Blood Draw. The percent change will be calculated separately for each Arm (reclined, supine). Based on previous studies, a positive outcome would be indicated by an increase in HR (i.e., positive percent change).
次要结局
未报告次要终点