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临床试验/NCT03599440
NCT03599440已完成不适用

Evaluation of the Effect of Different Types of Extended Infusion Lines on Pulse Contour-based Measurements Based on the Arterial Pressure Signal

Algemeen Ziekenhuis Maria Middelares1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10
试验地点
1
主要终点
relative change in ProAQT-calculated cardiac output after placement of extension lines.

研究概览

简要总结

Hemodynamic monitoring of the critically-ill patients is increasingly performed using an arterial pulse contour-based cardiac output device such as the proAQT system.

The aim of this study is to evaluate the effect of extending the pressure lines on the arterial pressure wave and the calculated hemodynamic variables when using the proAQT system.

详细描述

Hemodynamic continuous monitoring of critically-ill patients is increasingly performed with minimally-invasive methods, such as the proAQT sensor (PULSION Medical Systems SE, Munich, Germany).

The proAQT sensor calculates hemodynamic variables such as the cardiac output, stroke volume (variation), pulse-pressure variation and systemic vascular resistance by pulse contour analysis of the arterial pressure waveform using an arterial radial or femoral catheter. This minimal invasive technique, also permits continuous beat-to-beat assessment.

In patients in who an arterial catheter is placed for clinical reasons, the hemodynamic variables are continuously recorded. An extension line is coupled to a 3-way stopcock, connected to the proAQT sensor. In a neutral position of the 3-way stopcock, the pressure wave travels from the pressure sensor through the standard line. By turning the handle of the stopcock the standard line is bypassed and the pressure wave travels through the extended line.

The hemodynamic registration will be as follows:

  • two minutes in the neutral position;
  • two minutes with one type of extension line
  • two minutes in the neutral position
  • two minutes with a second type of extension line
  • two minutes in neutral position

研究设计

研究类型
Observational
观察模型
Other
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

  • arterial catheter necessary for clinical reasons

排除标准

  • 未提供

结局指标

主要结局

relative change in ProAQT-calculated cardiac output after placement of extension lines.

时间窗: one minute of measurement after changing the length of the extension line.

relative change (in % of the baseline measurement) in cardiac output following increase in length of the extension line.

次要结局

  • change in Area Under the Curve (AUC) of the arterial pressure wave form after placement of extension lines.(one minute of measurement after changing the length of the extension line.)
  • relative change in ProAQT-calculated SVR after placement of extension lines.(one minute of measurement after changing the length of the extension line.)
  • relative change in ProAQT-calculated diastolic blood pressure after placement of extension lines.(one minute of measurement after changing the length of the extension line.)
  • relative change in ProAQT-calculated systolic blood pressure after placement of extension lines.(one minute of measurement after changing the length of the extension line.)
  • relative change in ProAQT-calculated stroke volume variation after placement of extension lines.(one minute of measurement after changing the length of the extension line.)
  • relative change in ProAQT-calculated pulse pressure variation after placement of extension lines.(one minute of measurement after changing the length of the extension line.)

研究者

发起方
Algemeen Ziekenhuis Maria Middelares
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Alain Kalmar, MD, PhD

Staff Anesthesist

Algemeen Ziekenhuis Maria Middelares

研究点 (1)

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