Comparison of Compensatory Reserve Index to Intravascular Volume Change and Stroke Volume During Blood Donation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in Intravascular volume
研究概览
简要总结
The investigators have developed a system based on a pulse oximeter, a tablet, and an algorithm running on the tablet that analyzes the pulse oximeter waveform.
The algorithm that runs on this system should be able to accurately keep track of blood loss during blood donation. The investigators will compare the algorithm with the blood loss tracked by a device called a flow meter.
The algorithm that runs on this system should be able to accurately keep track of stroke volume changes. The investigators will compare the algorithm with the stroke volume changes tracked by a device called a CCNexfin.
The algorithm that runs on this system should work whether it's in place for the whole blood donation, or if it's placed after the blood donation has started. The investigators will use two pulse oximeters for the system on each hand and compare one that is used for the whole blood donation versus one that is not used for the whole blood donation.
详细描述
Hypothesis
p-values for testing the hypothesis of no correlation against the alternative that there is a nonzero correlation for each subject will be calculated. The minimum average power correlation, alpha = 0.05, will be used. Correlation will be made (CRI trend during 550ml blood volume removal) using pre and post blood draw data.
Specific Aims: These data will be submitted to the FDA with the following claims: The CRI algorithm
- Is intended for use by clinicians and medically qualified personnel to noninvasively display the trend of intravascular volume changes (hemorrhage)
- Is intended for use by clinicians and medically qualified personnel to noninvasively display the trend of stroke volume changes and
- The CRI trend value is not relative to an initial CRI reading, instead it is an actual CRI trend value that does
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is planning on donating blood and is approved by Children's Hospital Colorado's Blood Donation Center
- •Age 18-89 years
- •Previously donated blood (lower likelihood of vasovagal response)
排除标准
- •Incarcerated
- •Limited access to or compromised monitoring sites for non-invasive finger sensors
结局指标
主要结局
Change in Intravascular volume
时间窗: Day One
The CRI algorithm is intended to display the trend of intravascular volume changes. This is measured Day One.
Change in Stroke volume
时间窗: Day One
The CRI algorithm is intended to display the trend of stroke volume changes. This is measured Day One.
CRI trend
时间窗: Day One
The CRI algorithm is intended to not require calibration, or being placed, during normal physiological conditions. This is measured Day One.
次要结局
未报告次要终点