Second Generation DICART Prototype Validation for Patients With Acute Circulatory Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- clinical capillary refill time measurement.
研究概览
简要总结
Capillary refill time (CRT) is a clinical sign for diagnosis of acute circulatory failure and response to treatment but is also associated with prognosis in patient with shock.
CRT is clinically evaluated by physician with a high risk of inter and intra evaluator variations, depending, for example, on measurement site, pressure applicated or visual evaluation.
The investigator hypothesizes that CRT measurement with second generation DICART prototype will be well correlated with clinical measurement.
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
- 否
入选标准
- •>18 years old
- •Acute circulatory failure
- •Written informed consent given by patient or its relatives
排除标准
- •Pregnant women, breastfeeding women, childbearing age women without oral contraception
- •Cutaneous lesion at measurement site
- •Patient under legal protection
- •Patient already included in another interventional clinical trial
研究组 & 干预措施
measurement of capillary refill time
measurement in a cohort of ICU adult patients with acute circulatory failure
干预措施: Standardized measurement of capillary refill time by second generation DICART prototype (Device)
measurement of capillary refill time
measurement in a cohort of ICU adult patients with acute circulatory failure
干预措施: Clinical measurement of capillary refill time (Diagnostic Test)
结局指标
主要结局
clinical capillary refill time measurement.
时间窗: during procedure
Intraclass correlation coefficient between clinical and automatic DICART capillary refill time measurement.
automatic DICART capillary refill time measurement.
时间窗: during procedure
Intraclass correlation coefficient between clinical and automatic DICART capillary refill time measurement.
次要结局
- ROC curve with DICART device(during procedure)
- skin lesion assessed by clinical examination(during procedure)
- Inter-operator reproducibility in CRT measurement with DICART device(during procedure)
- survival rate without renal replacement therapy(30 days)
- pain evaluation by numerical rating scale(during procedure)
- Inter-operator reproducibility in CRT measurement with clinical method(during procedure)
- vital status(30 days)
- Intra-operator reproducibility in CRT measurement with clinical method(during procedure)
- Intra-operator reproducibility in CRT measurement with DICART device(during procedure)
- rash assessed by clinical examination(during procedure)