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临床试验/NCT01003665
NCT01003665已完成不适用

Accuracy of the CNAP™ Monitor (Continuous Non-invasive Arterial Pressure) Versus Invasive Radial Arterial Monitoring in Surgical Patients

University Hospital Schleswig-Holstein1 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2009年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
195
试验地点
1
主要终点
Bias and percentage error of CNAP compared with invasive arterial pressure measurement

研究概览

简要总结

The purpose of this study was to compare the Continuous Non-invasive Arterial Pressure (CNAP) monitor with the gold standard of invasive arterial pressure monitoring during:

  1. induction and maintenance of general anaesthesia
  2. intensive care unit treatment of postoperative patients with an ASA 3 or 4 status

详细描述

The CNAP monitor continuously measures blood pressure using a finger cuff. It showed a good agreement to invasive blood pressure measurements during anaesthesia induction and maintenance during surgery. In critical ill patients cardiac arrhythmia is probably a confounding factor affecting accuracy and interchangeability of CNAP. As systolic arterial CNAP pressure in comparison to mean pressure shows no statistical interchangeability with invasive measurements, mean pressure should be considered when making therapy decisions.

A problem is the missing standard criterion for comparison of continuously devices with invasive pressure.

研究设计

研究类型
Observational
观察模型
Case Control
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

  • BMI < 35 kg.m²
  • Patients capable of giving informed consent
  • patients undergoing elective surgical procedures in supine position under general anesthesia
  • perfusion of the examined arm evidenced by a positive Allen's test

排除标准

  • Patients not competent or unwilling to provide informed consent
  • Patients with history of neurological, neuromuscular seizure
  • Patients where IBP cannula, CNAP™ finger-cuff and CNAP™ upper arm cuff cannot be placed on the same arm

结局指标

主要结局

Bias and percentage error of CNAP compared with invasive arterial pressure measurement

时间窗: 1.) Induction of general anaesthesia. 2.) Maintanance of general anaesthesia. 3.) Intensive Care Treatement after surgery

次要结局

未报告次要终点

研究者

发起方
University Hospital Schleswig-Holstein
申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Hanss

Prof. Dr. Robert Hanss

University Hospital Schleswig-Holstein

研究点 (1)

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