Preload Dependency by Impedance Cardiography After Cardiac Surgery

Cardiac Surgery With Extracorporeal Circulation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02132871
• Other study ID #: 5516
• Status: Completed
• Phase: N/A
• First received: May 5, 2014
• Last updated: August 8, 2016
• Start date: May 2014
• Est. completion date: May 2016

Study information

• Verified date: August 2016
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: FRANCE : Comité Consultatif sur le Traitement de l'Information en matière de Recherche dans le domaine de la Santé (CCTIRS)FRANCE : Commission Nationale de l'Informatique et des Libertés (CNIL)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Surgery With Extracorporeal Circulation

Intervention

Device:
• Impedance cardiography Physioflow ®

Locations

Country	Name	City	State
France	Service d'Anesthésiologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Respiratory variation of inferior vena cava		Within the 6 first hours after cardiac surgery	No