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

Transesophageal Echocardiography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393897
• Other study ID #: IRBN662017
• Status: Completed
• Start date: January 3, 2018
• Est. completion date: October 31, 2018

Study information

• Verified date: January 2018
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transesophageal Echocardiography
• Vena Cava Superior

Intervention

Other:
• Trans oesophageal echocardiography
Transoesophageal echocardiography : it's a standard practice for this patient
• Trendelenburg test
Trendelenburg test : it's a standard practice for this patient

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diameter of vena cava superior	measured with trans oesophageal echocardiography	at 6 post-operative hours
Secondary	% of respiratory variations of maximal Doppler velocity in left ventricular outflow tract	measured with trans oesophageal echocardiography	at 6 post-operative hours
Secondary	% of respiratory variations of maximal Doppler velocity in pulmonary artery	measured with trans oesophageal echocardiography	at 6 post-operative hours
Secondary	% of pulse pressure respiratory variations	measured with trans oesophageal echocardiography	at 6 post-operative hours