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临床试验/NCT03933722
NCT03933722进行中(未招募)不适用

Comparison of Noninvasive Blood Pressure Monitoring With Invasive Arterial Pressure Monitoring in Patients With Septic Shock

The Cooper Health System1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年2月4日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Comparing blood pressure measurements by the Caretaker device to blood pressure measurements made with an intra-arterial pressure catheter.

研究概览

简要总结

Caretaker vs. Blood Pressure Monitoring With Invasive Arterial Pressure Monitoring in Patients With Septic Shock

详细描述

The aim of this study is to compare blood pressure obtained using routine blood pressure sphygmomanometer, in patients with invasive arterial pressure monitoring that have septic shock, to a non-invasive device that continuously monitors central blood pressure (CareTaker).

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted with septic shock, with or without vasopressor support needed.
  • Greater than or equal to 18 years of age.
  • Have an arterial catheter already in place.

排除标准

  • No arterial catheter in place.
  • Contraindication to the application of the Caretaker device due to pre-existing finger injury.
  • Patients in whom use of a BP cuff is contraindicated.

结局指标

主要结局

Comparing blood pressure measurements by the Caretaker device to blood pressure measurements made with an intra-arterial pressure catheter.

时间窗: 20 minutes

The primary outcome measure will be the average difference in systolic and diastolic blood pressure measurements between the investigational device (Caretaker) and the reference (intra-arterial catheter pressure) in subjects that have septic shock. In line with blood pressure validation guidelines, we will obtain multiple investigational-reference measurement pairs in each subject (20 minutes total) and will average the difference over all pairs from all subjects.

次要结局

  • Comparing blood pressure measurements by the Caretaker device to blood pressure measurements made with an upper arm cuff.(20 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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