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

Not Applicable

Completed

• Conditions: Hypovolemia
• Interventions: Device: arterial line; Device: Cheetah®

• Registration Number: NCT02774304
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Study Timeline

• Study First Submitted: 2016-04-01
• Study First Submitted QC: 2016-05-12
• Study First Posted: 2016-05-17
• Study Start: 2016-08
• Primary Completion: 2017-08
• Study Completion: 2017-11
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-10
• Last Update Posted: 2018-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
arterial line	arterial line	invasive haemodynamic monitoring
Cheetah®	Cheetah®	non-invasive cardiac output
Cheetah®	arterial line	non-invasive cardiac output
arterial line	Cheetah®	invasive haemodynamic monitoring

Primary Outcome Measures

Name	Time	Method
Dynamic Elastance	2 minutes	determination of stroke volume and pulse pressure variation: ratio of SPV/SVV

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Vlaams-Brabant, Belgium