Comparison of an Optical System to Continuously Measure Arterial Blood Pressure Against a Gold-standard Arterial Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Error (in mmHg) between paired determinations of arterial blood pressure from an optical device against reference measurements from an arterial catheter
研究概览
简要总结
Comparison of an optical method to continuously measure blood pressure against an invasive arterial catheter.
详细描述
The measurement of blood pressure during anesthesia is commonly performed by the inflation of a brachial cuff providing only intermittent blood pressure measurements. In some case, it is required to add a continuous invasive monitoring of blood pressure, via the insertion of an arterial catheter. Unfortunately, the related morbidity is not negligible. To limit the consequences of such a gesture, some developments have been done in the past to allow for continuous non-invasive measurements of blood pressure during anesthesia. Unfortunately, most of these devices are subject to important limitations and constraints of use.
A new system has been designed by CSEM consisting of an optical system fixed on patient's skin, absolutely non-invasive and easy to use. In order to study the reliability of this device, the investigators plan to compare its blood pressure estimates against gold-standard arterial catheter measurements during induction of general anesthesia on:
- 40 patients wearing the optical system at the chest.
- and 40 patients wearing the optical system at the fingertip
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- 是
入选标准
- •patient requiring the placement of an arterial catheter for general anesthesia
- •minimum of 18 years
- •written consent
排除标准
- •minor patient or incapable of discernment
- •patient with AIMD
- •thoracic surgery
研究组 & 干预措施
OBPM 2015-MD-0022 - CHEST
Cohort of 30 patients undergoing general anesthesia, monitored by optical signals at the chest
干预措施: Experimental: OBPM 2015-MD-0022 - CHEST (Device)
OBPM 2015-MD-0022 - CHEST & FINGER
Cohort of 10 patients undergoing general anesthesia, monitored by optical signals at the chest and at the fingertip
干预措施: Experimental: OBPM 2015-MD-0022 - CHEST & FINGER (Device)
OBPM 2015-MD-0022 - FINGER
Cohort of 30 patients undergoing general anesthesia, monitored by optical signals at the fingertip
干预措施: Experimental: OBPM 2015-MD-0022 - FINGER (Device)
结局指标
主要结局
Error (in mmHg) between paired determinations of arterial blood pressure from an optical device against reference measurements from an arterial catheter
时间窗: 24 months
The signals recorded by the optical blood pressure device will be retrospectively analysed (offline analysis) in order to test the hypothesis that blood pressure values as derived by the new device is comparable to blood pressure values as measured by an arterial catheter within the limits of agreement in mmHg stated by ISO 81060-2 2013.
次要结局
未报告次要终点