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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02774304
Acronym
Eadyn
Enrollment
30
Registered
2016-05-17
Start date
2016-08-31
Completion date
2017-11-30
Last updated
2018-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypovolemia

Keywords

elastance, fluid responsiveness

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 description

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.

Interventions

DEVICEarterial line

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

DEVICECheetah®

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

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dynamic Elastance2 minutesdetermination of stroke volume and pulse pressure variation: ratio of SPV/SVV

Secondary

MeasureTime frameDescription
Stroke volume variation (SVV)2 minutesVariation of stroke volume (area under the arterial or oxygen saturation curve) during mechanical ventilation
Systolic pressure variation (SPV)2 minutesVariation of systolic pressure or peak oxygen saturation during mechanical ventilation

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026