NCT02132871

Brief Summary

The primary purpose of this study is to investigate wether the measure of stroke volume (SV) variations by impedance cardiography during passive leg raising (PLR) can reliably predict preload dependency after cardiac surgery, in comparison to a reference parameter : velocity time integral (VTI) variation measured by transthoracical echocardiography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2014

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

August 9, 2016

Status Verified

August 1, 2016

Enrollment Period

2 years

First QC Date

May 5, 2014

Last Update Submit

August 8, 2016

Conditions

Cardiac Surgery With Extracorporeal Circulation

Outcome Measures

Primary Outcomes (1)

  • Area under ROC curve comparing SV variation (impedance cardiography) and VTI variation after PLR

    Patients classified as responders and non responders to PLR : VTI variation ≥ 12% or \< 12%

    Within the 6 first hours after cardiac surgery

Secondary Outcomes (2)

  • Variation of central veinous pressure, left auricular pressure and left ventricular filling pressures after PLR (ROC curves, correlation tests)

    Within the 6 first hours after cardiac surgery

  • Respiratory variation of inferior vena cava

    Within the 6 first hours after cardiac surgery

Study Arms (1)

1

Device: Impedance cardiography Physioflow ®

Interventions

Impedance cardiography Physioflow ®DEVICE
1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients requiring cardiac surgery

You may qualify if:

  • Men or women over 18 years
  • Affiliated to a social protection
  • Signed written consent
  • Informed about the results of the medical visit
  • All type of cardiac surgery with extracorporeal circulation performed at University Hospital of Strasbourg
  • Sedated and under mechanical ventilation

You may not qualify if:

  • Cardiac arrhythmia
  • Contraindication to PLR maneuver
  • Impossibility to provide enlightened information
  • Patient deprived of liberty, under judicial protection, trusteeship or guardianship
  • Pregnancy, lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Anesthésiologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Study Officials

  • Nassim HESHMATI, MD

    Hôpitaux Universitaires de Strasbourg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2014

First Posted

May 7, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

August 9, 2016

Record last verified: 2016-08

Locations

FR(1)