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Assessment of Arterial Dynamic Elastance as a Function Variable of Arterial Load (Eadyn)

Primary Purpose

Hypovolemia

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
arterial line
Cheetah®
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hypovolemia focused on measuring elastance, fluid responsiveness

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Universitair Ziekenhuis Brussel

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

arterial line

Cheetah®

Arm Description

invasive haemodynamic monitoring

non-invasive cardiac output

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 1, 2016
Last Updated
October 10, 2018
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT02774304
Brief Title
Assessment of Arterial Dynamic Elastance as a Function Variable of Arterial Load
Acronym
Eadyn
Official Title
Assessment of Arterial Dynamic Elastance as a Function Variable of Arterial Load, Derived From Both Non-invasive and Invasive Haemodynamic Variables.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 2016 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
November 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypovolemia
Keywords
elastance, fluid responsiveness

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
arterial line
Arm Type
Active Comparator
Arm Description
invasive haemodynamic monitoring
Arm Title
Cheetah®
Arm Type
Experimental
Arm Description
non-invasive cardiac output
Intervention Type
Device
Intervention Name(s)
arterial line
Intervention Description
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
Intervention Name(s)
Cheetah®
Intervention Description
In mechanically ventilated patients systolic pressure variation will be captured and passive leg raising with positive result fluid filling will be initiated.
Primary Outcome Measure Information:
Title
Dynamic Elastance
Description
determination of stroke volume and pulse pressure variation: ratio of SPV/SVV
Time Frame
2 minutes
Secondary Outcome Measure Information:
Title
Stroke volume variation (SVV)
Description
Variation of stroke volume (area under the arterial or oxygen saturation curve) during mechanical ventilation
Time Frame
2 minutes
Title
Systolic pressure variation (SPV)
Description
Variation of systolic pressure or peak oxygen saturation during mechanical ventilation
Time Frame
2 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Vervoort, Ir
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jan Poelaert, MD, PhD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tina Maes, MD
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Study Chair
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Jette
State/Province
Vlaams-Brabant
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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

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