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

NCT ID: NCT02774304

Last Updated: 2018-10-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-11-30

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.

Conditions

Hypovolemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

arterial line

invasive haemodynamic monitoring

Group Type: ACTIVE_COMPARATOR

arterial line

Intervention Type: DEVICE

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

Cheetah®

Intervention Type: DEVICE

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

Cheetah®

non-invasive cardiac output

Group Type: EXPERIMENTAL

arterial line

Intervention Type: DEVICE

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

Cheetah®

Intervention Type: DEVICE

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

Interventions

arterial line

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

Intervention Type: DEVICE

Cheetah®

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role: lead

Responsible Party

Veerle Van Mossevelde

Data Nurse

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Michel Vervoort, Ir

Role: STUDY_DIRECTOR

Universitair Ziekenhuis Brussel

Jan Poelaert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Tina Maes, MD

Role: STUDY_CHAIR

Universitair Ziekenhuis Brussel

Locations

Universitair Ziekenhuis Brussel

Jette, Vlaams-Brabant, Belgium

Countries

Belgium

Other Identifiers

Eadyn version 1.0

Identifier Type: -

Identifier Source: org_study_id