DiCART TM Device for Capillary Refill Time Measurement : a Validation Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Capillary refill time on the thenar eminence evaluated with DiCART TM device.
研究概览
简要总结
To estimate peripheral perfusion in shock state, international guidelines recommend the use of capillary refill time, and practitioners currently evaluates it at bedside. However its measurement is not standardized, what should explain the large observer variability reported in different studies. Hence, a device providing a standardized evaluation seems to be helpful.
The aim of the study is to evaluate diagnostic performance of such a device recently developped (DiCART TM), in healthy volunteers experiencing vascular occlusion tests to induce impaired perfusion.
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
盲法说明
the investigators evaluate capillary refill time without knowing the status of vascular occlusion test.
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
- •Healthy volunteers
- •Age > 18 years old
- •Informed consent to participate
排除标准
- •Vascular disease
- •Diabetes mellitus
- •Dermatosis
- •Cutaneous lesion on a measurement site
- •Pregnancy
- •Cardiovascular chronic treatment
- •Non affiliation to a social security regime
- •Involvement in other interventional study
结局指标
主要结局
Capillary refill time on the thenar eminence evaluated with DiCART TM device.
时间窗: 180 minutes
Diagnostic performance of DiCART TM device to detect a capillary refill time variation on the thenar eminence induced by a vascular occlusion test on the arm. DiCART TM measurement is fully automatized, and may be separated in three consecutive step : * An automatized cutaneous compression * A video acquisition of cutaneous recoloration * Data interpretation The investigators will compute Receptor Operative Characteristics curves with area under the curve, and will determine best threshold and grey zone to evaluate diagnostic performance of DiCART TM device to detect impaired perfusion.
次要结局
- Capillary refill time variation induced by vascular occlusion test on the thenar eminence with standard clinical method.(180 minutes)
- Pain evaluation assessed by numeric rating scale(180 minutes)
- Capillary refill time evaluated on the knee with DiCART TM device(180 minutes)
- Intra -observer variability of capillary refill time measurement with DiCART TM device by performing repetitive measurements by two different investigators.(180 minutes)
- Capillary refill time variation induced by vascular occlusion test on the thenar eminence with DiCART TM device .(180 minutes)
- Intra -observer variability of capillary refill time measurement with clinical method by performing repetitive measurements by two different investigators.(180 minutes)
- Capillary refill time variation induced by vascular occlusion test on the knee with standard clinical method(180 minutes)
- number of patients with cutaneous lesions(180 minutes)
- Inter-observer variability of capillary refill time measurement with DiCART TM device by performing repetitive measurements by two different investigators.(180 minutes)
- Capillary refill time measured by mathematical algorithms(180 minutes)
- Inter-observer variability of capillary refill time measurement with clinical method by performing repetitive measurements by two different investigators.(180 minutes)
- Capillary refill time variation induced by vascular occlusion test on the knee with DiCART TM device(180 minutes)