Preload Dependency by Impedance Cardiography After Cardiac Surgery

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: Cardiac Surgery With Extracorporeal Circulation
• Intervention / Treatment: Device: Impedance cardiography Physioflow ®

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

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	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)	Within the 6 first hours after cardiac surgery
Respiratory variation of inferior vena cava	Within the 6 first hours after cardiac surgery

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Nassim HESHMATI, MD, Hôpitaux Universitaires de Strasbourg

Study record dates

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