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Completed

NCT Number: NCT02132871

Preload Dependency by Impedance Cardiography 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.

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Key information

Conditions

Cardiac Surgery With Extracorporeal Circulation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Strasbourg, 67091, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Impedance cardiography Physioflow ®

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 7, 2014
Registry last updated
Aug 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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