NCT02774304

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

October 11, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

April 1, 2016

Last Update Submit

October 10, 2018

Conditions

Hypovolemia

Keywords

elastancefluid responsiveness

Outcome Measures

Primary Outcomes (1)

  • Dynamic Elastance

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

    2 minutes

Secondary Outcomes (2)

  • Stroke volume variation (SVV)

    2 minutes

  • Systolic pressure variation (SPV)

    2 minutes

Study Arms (2)

arterial line

ACTIVE COMPARATOR

invasive haemodynamic monitoring

Device: arterial lineDevice: Cheetah®

Cheetah®

EXPERIMENTAL

non-invasive cardiac output

Device: arterial lineDevice: Cheetah®

Interventions

arterial lineDEVICE

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

Cheetah®arterial line
Cheetah®DEVICE

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

Cheetah®arterial line

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Minor surgery and absence of arterial pressure monitoring

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, Vlaams-Brabant, 1090, Belgium

Location

MeSH Terms

Conditions

Hypovolemia

Interventions

Vascular Access Devices

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CathetersEquipment and Supplies

Study Officials

  • Michel Vervoort, Ir

    Universitair Ziekenhuis Brussel

    STUDY DIRECTOR

  • Jan Poelaert, MD, PhD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

  • Tina Maes, MD

    Universitair Ziekenhuis Brussel

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Data Nurse

Study Record Dates

First Submitted

April 1, 2016

First Posted

May 17, 2016

Study Start

August 1, 2016

Primary Completion

August 1, 2017

Study Completion

November 1, 2017

Last Updated

October 11, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)