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Completed

NCT Number: NCT02774304

Assessment of Arterial Dynamic Elastance as a Function Variable of Arterial Load

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel

Jette, Vlaams-Brabant, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Minor surgery and absence of arterial pressure monitoring

Treatment and study plan

Arterial line

Device

In mechanically ventilated patients systolic pressure variation will be captured and passive leg raising with positive result fluid filling will be initiated.

Cheetah®

Device

In mechanically ventilated patients systolic pressure variation will be captured and passive leg raising with positive result fluid filling will be initiated.

Primary outcomes

  1. Dynamic Elastance

    Time frame: 2 minutes

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

Secondary outcomes

  1. Stroke volume variation (SVV)

    Time frame: 2 minutes

    Variation of stroke volume (area under the arterial or oxygen saturation curve) during mechanical ventilation

  2. Systolic pressure variation (SPV)

    Time frame: 2 minutes

    Variation of systolic pressure or peak oxygen saturation during mechanical ventilation

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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

Acronym: Eadyn

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 17, 2016
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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