Photopletysmography Detects Early Acute Blood Loss in Compensated Blood Donor Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Analysis of the continuous component (DC) of the photoplethysmography signal.
研究概览
简要总结
Hypovolemia caused by acute bleeding increased morbi-mortality in emergency and operatin rooms. Precise real-time diagnosis of incipient acute hypovolemia is lacking at the bedside. We hypothesize that the infrared-red signals of pulse oximetry are sensitive to acute changes in patient's volemia. We aimed to test this hypothesis in a cohort of healthy blood donors as a model of simulated acute hypovolemia.
详细描述
This is a prospective and observational study designed to determine if the changes observed in finger photoplethysmographic waveform can detect incipient hypovolemia. The investigators will studied 60 blood donor volunteers as a model of slight hypovolemia (8-10% of the volemia). Vital signs and photoplethysmography will be recorded in the thumb of the tested hand during a standard blood donation protocol. Recorded data will be analyzed and compared before and after blood donation .
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written Inform Consent
- •weight > 50 kg,
- •hemoglobin >12.5 gr/dl
排除标准
- •pregnancy,
- •≤ 12 months from delivery or abortion,
- •symptoms of allergy,
- •fever >37 °C,
- •infectious diseases,
- •addictions,
- •volunteers that received previous blood transfusions
结局指标
主要结局
Analysis of the continuous component (DC) of the photoplethysmography signal.
时间窗: 15 minutes
The DC components of photoplethysmography is measured in arbitrary units (a.u).
次要结局
- Analysis of non-invasive arterial blood pressure (NIBP)(15 minutes)