Preload Dependency by Impedance Cardiography After Cardiac Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02132871
Recruitment Status : Completed
First Posted : May 7, 2014
Last Update Posted : August 9, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cardiac Surgery With Extracorporeal Circulation Device: Impedance cardiography Physioflow ®

Study Type : Observational
Actual Enrollment : 65 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninvasive Assessment of Preload Dependency by Passive Leg Raising Test and Impedance Cardiography Compared to Echocardiographic Measurements After Cardiac Surgery
Study Start Date : May 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery
U.S. FDA Resources

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

Primary Outcome Measures :
  1. 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%

Secondary Outcome Measures :
  1. 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 ]
  2. Respiratory variation of inferior vena cava [ Time Frame: Within the 6 first hours after cardiac surgery ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients requiring cardiac surgery

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02132871

Service d'Anesthésiologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Principal Investigator: Nassim HESHMATI, MD Hôpitaux Universitaires de Strasbourg

Responsible Party: University Hospital, Strasbourg, France Identifier: NCT02132871     History of Changes
Other Study ID Numbers: 5516
First Posted: May 7, 2014    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016