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临床试验/NCT03642756
NCT03642756Unknown不适用

Effects of Different Intra-arterial Catheter Size on the Frequency of Optimal Dynamic Response in Radial Arterial Waveform

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 366 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
366
试验地点
1
主要终点
The frequency of adequately damped arterial waveform

研究概览

简要总结

The aim of this study is to compare the effects of different intra-arterial catheter size on the frequency of optimal dynamic response in radial arterial waveform.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients who were scheduled for elective neurosurgery under general anesthesia
  • patients with age of 20-79 and ASA class I-III
  • patients who are needed to establish invasive arterial pressure monitoring

排除标准

  • patients who refuted to be involved in the study
  • patients with age of <20 or >80
  • patients who had both arm saved
  • patients who had a previous history of surgery on radial artery

研究组 & 干预措施

20 gauge

Placebo Comparator

干预措施: different intra-arterial catheter size (Device)

22 gauge

Active Comparator

干预措施: different intra-arterial catheter size (Device)

24 gauge

Active Comparator

干预措施: different intra-arterial catheter size (Device)

结局指标

主要结局

The frequency of adequately damped arterial waveform

时间窗: 1 minute after cannulation

The accuracy of arterial blood pressure waveform is depedent on damping coefficient (DC) and natural frequency (NF). The extent to which a monitoring system is damped is expressed by the DC, while the frequency of oscillation that a monitoring system resonates at is known as the NF. The NF and DC are required to be within certain rages for accurate blood pressure monitoring, and they can be affected by different arterial catheter size. Adequately damped arterial waveform can be defined as NF and DC being within certain ranges. For example, waveforms with DC of 0.5 at a NF of 15Hz can be regarded as adequately damped arterial waveform. However, if waveforms have DC of 0.1 at a NF of 15Hz, these can be regarded as not having optimal dynamic response. (There is a reference figure explaining these factors in detail in a previous article. Gardner RM: Direct blood pressure measurement--dynamic response requirements. Anesthesiology 1981; 54:227-3)

次要结局

  • The difference of mean blood pressure between invasive blood pressure and non-invasive blood pressure(1 minute after cannulation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hee-Pyoung Park

Professor

Seoul National University Hospital

研究点 (1)

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