跳至主要内容
临床试验/NCT02774304
NCT02774304已完成不适用

Assessment of Arterial Dynamic Elastance as a Function Variable of Arterial Load, Derived From Both Non-invasive and Invasive Haemodynamic Variables.

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Dynamic Elastance

研究概览

简要总结

The goal of the study is to determine Eadyn as a functional measure of arterial load, in conjunction with other actual afterload indices, derived from both invasive arterial pressure tracing and non-invasive signals, such as arterial saturation, non-invasive cardiac output obtained by bio-reactance, and non-invasive stroke volume. A secondary aim is the correlation of the different non-invasive signals with the invasive arterial pressure tracing characteristics.

详细描述

Fifteen patients, who provide written informed consent, will be included. All of them are scheduled for a major surgical intervention, in whom standard haemodynamic monitoring includes arterial pressure monitoring.

Non-invasive wired patches, connected to a Cheetah cardiac output monitor, will be installed, as well as traditional haemodynamic monitoring (ECG, SaO2, non-invasive blood pressure). A computer link between a Philips monitor (MP50 or MP70) is made, to obtain selected curves in a digital format for post-intervention processing. After awake insertion of an arterial catheter in the radial or brachial artery and induction of anaesthesia, patient becomes intubated and mechanically ventilated.

Before surgery, following data will be registered for 5 min.: ECG, invasive arterial pressure tracing, cardiac output (Cheetah monitor), SaO2 tracing, arterial pressure tracing and pulse pressure and stroke volume variation (Nexfin).

When SVV > 15%, the operation table will be put in Passive Leg Raising (PLR) to optimize the filling status of the patient (test of preload dependency). When positive haemodynamic reaction is present, the patients will obtain a rapid infusion bolus of 250 ml of crystalloids.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All patients scheduled for a major surgical intervention, in whom standard haemodynamic monitoring includes arterial pressure monitoring.

排除标准

  • •Minor surgery and absence of arterial pressure monitoring

研究组 & 干预措施

arterial line

Active Comparator

invasive haemodynamic monitoring

干预措施: arterial line (Device)

arterial line

Active Comparator

invasive haemodynamic monitoring

干预措施: Cheetah® (Device)

Cheetah®

Experimental

non-invasive cardiac output

干预措施: arterial line (Device)

Cheetah®

Experimental

non-invasive cardiac output

干预措施: Cheetah® (Device)

结局指标

主要结局

Dynamic Elastance

时间窗: 2 minutes

determination of stroke volume and pulse pressure variation: ratio of SPV/SVV

次要结局

  • Stroke volume variation (SVV)(2 minutes)
  • Systolic pressure variation (SPV)(2 minutes)

研究者

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

Veerle Van Mossevelde

Data Nurse

Universitair Ziekenhuis Brussel

研究点 (1)

Loading locations...

相似试验