Clinical Trial: Assessment of Arterial Dynamic Elastance as a Function Variable of Arterial Load

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Universitair Ziekenhuis Brussel

Current Primary Outcome: Dynamic Elastance [ Time Frame: 2 minutes ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Stroke volume variation (SVV) [ Time Frame: 2 minutes ]
    Variation of stroke volume (area under the arterial or oxygen saturation curve) during mechanical ventilation
  • Systolic pressure variation (SPV) [ Time Frame: 2 minutes ]
    Variation of systolic pressure or peak oxygen saturation during mechanical ventilation


Original Secondary Outcome: Same as current

Information By: Universitair Ziekenhuis Brussel

Dates:
Date Received: April 1, 2016
Date Started: June 2016
Date Completion: July 2017
Last Updated: December 5, 2016
Last Verified: December 2016