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

NCT03393897 | Completed

• 1 other identifier: IRBN662017
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Transesophageal Echocardiography; Vena Cava Superior

Keywords

fluid responsiveness; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• diameter of vena cava superior

  measured with trans oesophageal echocardiography

  at 6 post-operative hours

Secondary Outcomes (3)

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

  at 6 post-operative hours

• % of respiratory variations of maximal Doppler velocity in pulmonary artery

  at 6 post-operative hours

• % of pulse pressure respiratory variations

  at 6 post-operative hours

Study Arms (1)

Hemodynamic instability with hypotension

Other: Trans oesophageal echocardiography; Other: Trendelenburg test

Interventions

Trans oesophageal echocardiography OTHER

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

Hemodynamic instability with hypotension

Trendelenburg test OTHER

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

Hemodynamic instability with hypotension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with hemodynamic instability and hypotension

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (1)

Centre Hospitalier Universitaire de Saint Etienne

Saint-Etienne, 42055, France

Location

Study Officials

• Olivier PEYROUSET, MD

  CHU SAINT-ETIENNE

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2018
• First Posted: January 9, 2018
• Study Start: January 3, 2018
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)