Preload Dependency by Impedance Cardiography After Cardiac Surgery

August 8, 2016 updated by: University Hospital, Strasbourg, France

Noninvasive Assessment of Preload Dependency by Passive Leg Raising Test and Impedance Cardiography Compared to Echocardiographic Measurements After Cardiac Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67091
        • Service d'Anesthésiologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients requiring cardiac surgery

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Cardiac arrhythmia
  • Contraindication to PLR maneuver
  • Exclusion period due to inclusion in a previous or ongoing study
  • Impossibility to provide enlightened information
  • Patient deprived of liberty, under judicial protection, trusteeship or guardianship
  • Pregnancy, lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
1
Device: Impedance cardiography Physioflow ®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under ROC curve comparing SV variation (impedance cardiography) and VTI variation after PLR
Time Frame: Within the 6 first hours after cardiac surgery
Patients classified as responders and non responders to PLR : VTI variation ≥ 12% or < 12%
Within the 6 first hours after cardiac surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Variation of central veinous pressure, left auricular pressure and left ventricular filling pressures after PLR (ROC curves, correlation tests)
Time Frame: Within the 6 first hours after cardiac surgery
Within the 6 first hours after cardiac surgery
Respiratory variation of inferior vena cava
Time Frame: Within the 6 first hours after cardiac surgery
Within the 6 first hours after cardiac surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Nassim HESHMATI, MD, Hôpitaux universitaires de Strasbourg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

May 5, 2014

First Submitted That Met QC Criteria

May 5, 2014

First Posted (Estimate)

May 7, 2014

Study Record Updates

Last Update Posted (Estimate)

August 9, 2016

Last Update Submitted That Met QC Criteria

August 8, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 5516

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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