Comparison Study of EzCVP and CVP
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Nihon Kohden
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Non-invasive pressure indicator
研究概览
简要总结
Comparison of a non-invasive method of measuring central venous pressure to the conventional modality of invasive central venous pressure.
详细描述
The conventional method used to measure central venous pressure has limitations since it is an invasive procedure that requires a central venous catheter. To overcome this challenge, a new technology to assess CVP non-invasively using an oscillometric method is being developed. It is called enclosed zone central venous pressure (ezCVP). A comparison study of ezCVP and CVP is needed to determine accuracy and reproducibility.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
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
- •Adult age over 18 years.
- •Arm circumference is 23 cm to 55 cm
- •Subject will have an existing central venous catheter during their ICU stay
- •Subject or legally authorized representative (LAR) is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent
- •Subject or LAR is willing and able to comply with protocol procedures
排除标准
- •Finger and/or upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff.
- •Pregnant (self-reported)
- •Upper extremity deep venous thrombosis currently being treated
- •Severe skin disease involving the upper arm(s)
- •Study investigator may exclude patients based on clinical judgement
结局指标
主要结局
Non-invasive pressure indicator
时间窗: 12-72 hours
Evaluate sensitivity and specificity of ezCVP indication based on the case where CVP is in a 'low range' (0 \< CVP \< 10 mmHg) or 'high range' (\>= 10 mmHg)
次要结局
- Direction of change(12-72 hours)
- Correlation with invasive CVP(12-72 hours)