Preload Dependency by Impedance Cardiography After Cardiac Surgery

Completed

• Conditions: Cardiac Surgery With Extracorporeal Circulation
• Interventions: Device: Impedance cardiography Physioflow ®

• Registration Number: NCT02132871
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-05
• Study First Submitted QC: 2014-05-05
• Study First Posted: 2014-05-07
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-08
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Impedance cardiography Physioflow ®	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Service d'Anesthésiologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France