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Completed

NCT Number: NCT03393897

Respiratory Variations of the Diameter of Superior Vena Cava for Predicting Fluid Responsiveness After Cardiac Surgery

In a recent study (Vignon 2017), respiratory variations of the diameter of superior vena cava had a greater diagnostic accuracy than pulse pressure variations and inferior vena cava respiratory variations in 540 medical and surgical ICU patients. But this indicator has not been investigated yet in cardiac surgery. The investigator aim to study respiratory variations of superior vena cava for predicting fluid responsiveness after cardiac surgery.

In post-operative cardiac surgery patients with hemodynamic failure, the investigator will measure respiratory vena caval variations with TEE (Trans oesophageal echocardiography). Then, the investigator will evaluate fluid responsiveness after a fluid challenge (Trendelenburg).

A ROC curve will be constructed in order to assess the optimal sensitivity and specificity of this parameter.

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Key information

Conditions

Transesophageal Echocardiography Vena Cava Superior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Universitaire de Saint Etienne

Saint-Etienne, 42055, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Hemodynamic instability with hypotension,
  • Low cardiac output or norepinephrine requirements in the first 6 post-operative hours.

Exclusion criteria

  • TEE (Trans oesophageal echocardiography) contra-indication
  • Trendelenburg contra-indication

Treatment and study plan

Trans oesophageal echocardiography

Other

Transoesophageal echocardiography : it's a standard practice for this patient

Trendelenburg test

Other

Trendelenburg test : it's a standard practice for this patient

Primary outcomes

  1. diameter of vena cava superior

    Time frame: at 6 post-operative hours

    measured with trans oesophageal echocardiography

Secondary outcomes

  1. % of respiratory variations of maximal Doppler velocity in left ventricular outflow tract

    Time frame: at 6 post-operative hours

    measured with trans oesophageal echocardiography

  2. % of respiratory variations of maximal Doppler velocity in pulmonary artery

    Time frame: at 6 post-operative hours

    measured with trans oesophageal echocardiography

  3. % of pulse pressure respiratory variations

    Time frame: at 6 post-operative hours

    measured with trans oesophageal echocardiography

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 9, 2018
Registry last updated
Dec 19, 2018

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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