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

Completed

• Conditions: Vena Cava Superior; Transesophageal Echocardiography
• Interventions: Other: Trans oesophageal echocardiography; Other: Trendelenburg test

• Registration Number: NCT03393897
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-01
• Study Start: 2018-01-03
• Study First Submitted: 2018-01-03
• Study First Submitted QC: 2018-01-03
• Study First Posted: 2018-01-09
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Last Update Submitted: 2018-12-16
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemodynamic instability with hypotension	Trans oesophageal echocardiography	-
Hemodynamic instability with hypotension	Trendelenburg test	-

Primary Outcome Measures

Name	Time	Method
diameter of vena cava superior	at 6 post-operative hours	measured with trans oesophageal echocardiography

Secondary Outcome Measures

Name	Time	Method
% of pulse pressure respiratory variations	at 6 post-operative hours	measured with trans oesophageal echocardiography
% of respiratory variations of maximal Doppler velocity in pulmonary artery	at 6 post-operative hours	measured with trans oesophageal echocardiography
% of respiratory variations of maximal Doppler velocity in left ventricular outflow tract	at 6 post-operative hours	measured with trans oesophageal echocardiography

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Saint Etienne; 🇫🇷 Saint Etienne, France