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

December 16, 2018 updated by: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

56

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint Etienne, France, 42055
        • Centre Hospitalier Universitaire de Saint Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with hemodynamic instability and hypotension

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hemodynamic instability with hypotension
Other: Trans oesophageal echocardiography
Transoesophageal echocardiography : it's a standard practice for this patient
Other: Trendelenburg test
Trendelenburg test : it's a standard practice for this patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diameter of vena cava superior
Time Frame: at 6 post-operative hours
measured with trans oesophageal echocardiography
at 6 post-operative hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Olivier PEYROUSET, MD, CHU Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2018

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

October 31, 2018

Study Registration Dates

First Submitted

January 3, 2018

First Submitted That Met QC Criteria

January 3, 2018

First Posted (Actual)

January 9, 2018

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IRBN662017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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