跳至主要内容
临床试验/NCT02479724
NCT02479724已完成不适用

A-line/CareTaker Comparison Study in ICU Patients

Empirical Technologies Corporation0 个研究点目标入组 60 人开始时间: 2012年1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
60
主要终点
Performance comparison according to AAMI/ANSI/ISO 81060-1:2013

研究概览

简要总结

Comparison of Blood Pressures obtained with the Pulse Decomposition Algorithm and Intra-Arterial Catheters in ICU Patients

详细描述

The object of the work presented here was to validate a new approach to tracking blood pressure that is based on the pulse analysis of the peripheral arterial pressure pulse. The approach, referred to as the Pulse Decomposition Analysis (PDA) model, goes beyond traditional pulse analysis by invoking a physical model that comprehensively links the components of the peripheral pressure pulse envelope with two reflection sites in the central arteries.

In these experiments, approved by the University of Virginia Institutional Review Board, the arterial blood pressures of patients (23 m/11 f, mean age: 44.05 y, SD: 13.9 y, mean height: 173.3 cm, SD: 9.4 cm, mean weight: 95.3 kg, SD: 27.4 kg) hospitalized in University of Virginia Medical Intensive Care Units (MICUs) were monitored using radial intra-arterial catheters, while the CareTaker system collected pulse line shapes at the lower phalange of the thumb of the ipsilateral hand.

Systolic and diastolic blood pressures continuously collected from the arterial catheter and CT were compared. Pearson correlation coefficients were calculated between arterial catheter and CT blood pressure measurements and a Bland-Altman analysis was created. Results were within the limits established for the validation of automatic arterial pressure monitoring (AAMI/ANSI/ISO 81060-1:2013).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • male or female age 18 to 45
  • presence of a radial arterial catheter
  • informed consent by subject or surrogate
  • available digital pulse

排除标准

  • failure to meet all of the inclusion criteria

结局指标

主要结局

Performance comparison according to AAMI/ANSI/ISO 81060-1:2013

时间窗: 40 minutes

Correlation and standard deviation between both blood pressure measurement systems were assessed according to 81060 standards.

次要结局

未报告次要终点

研究者

发起方
Empirical Technologies Corporation
申办方类型
Industry
责任方
Sponsor

相似试验