Transesophageal EchocardiographyNCT03393897
Respiratory Variations of the Diameter of Superior Vena Cava for Predicting Fluid Responsiveness After Cardiac Surgery
An observational study of Transesophageal Echocardiography and Vena Cava Superior, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transesophageal Echocardiography, Vena Cava Superior
- What is being tested?
- Trans oesophageal echocardiography and Trendelenburg test
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2018to 31 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with hemodynamic instability and hypotension
Who may be able to join
- Hemodynamic instability with hypotension,
- Low cardiac output or norepinephrine requirements in the first 6 post-operative hours.
Who cannot join
- TEE (Trans oesophageal echocardiography) contra-indication
- Trendelenburg contra-indication
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de Saint Etienne
Saint-Etienne, 42055
About this study
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.
- Being tested
- Trans oesophageal echocardiography, Trendelenburg test
- Keywords
- fluid responsiveness, cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans oesophageal echocardiographyOther
Transoesophageal echocardiography : it's a standard practice for this patient
Trendelenburg testOther
Trendelenburg test : it's a standard practice for this patient
| Study group | Role | What they receive |
|---|---|---|
| Hemodynamic instability with hypotension | Not described Receives: Other: Trans oesophageal echocardiography; Other: Trendelenburg test |
What is being measured
The primary outcome is the main question the study is designed to answer.
diameter of vena cava superior
measured with trans oesophageal echocardiography
Measured: at 6 post-operative hours
Secondary outcomes (3)
% of respiratory variations of maximal Doppler velocity in left ventricular outflow tract
measured with trans oesophageal echocardiography
Measured: at 6 post-operative hours
% of respiratory variations of maximal Doppler velocity in pulmonary artery
measured with trans oesophageal echocardiography
Measured: at 6 post-operative hours
% of pulse pressure respiratory variations
measured with trans oesophageal echocardiography
Measured: at 6 post-operative hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start3 Jan 2018
- Primary completion31 Oct 2018
- Study completion31 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transesophageal EchocardiographyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier PEYROUSET, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393897
- Sponsor's protocol ID
- IRBN662017
- Status last verified
- Jan 2018
- First submitted
- 3 Jan 2018
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Variations of the Diameter of Superior Vena Cava for Predicting Fluid Responsiveness After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT03393897
- Acronym / sponsor ID
- IRBN662017
- Keywords
- fluid responsiveness, cardiac surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 31 Oct 2018 (actual)
- First posted
- 9 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemodynamic instability with hypotension | – | Other: Trans oesophageal echocardiography, Other: Trendelenburg test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with hemodynamic instability and hypotension
Key inclusion criteria (2 listed)
- Hemodynamic instability with hypotension,
- Low cardiac output or norepinephrine requirements in the first 6 post-operative hours.
Key exclusion criteria (2 listed)
- TEE (Trans oesophageal echocardiography) contra-indication
- Trendelenburg contra-indication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans oesophageal echocardiographyTransoesophageal echocardiography : it's a standard practice for this patient | Other | Hemodynamic instability with hypotension |
| Trendelenburg testTrendelenburg test : it's a standard practice for this patient | Other | Hemodynamic instability with hypotension |
Primary outcome
diameter of vena cava superior
Time frame: at 6 post-operative hours
measured with trans oesophageal echocardiography
3 secondary outcomes
% of respiratory variations of maximal Doppler velocity in left ventricular outflow tract
Time frame: at 6 post-operative hours
% of respiratory variations of maximal Doppler velocity in pulmonary artery
Time frame: at 6 post-operative hours
% of pulse pressure respiratory variations
Time frame: at 6 post-operative hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier PEYROUSET, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Transesophageal Echocardiography and Vena Cava Superior, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diameter of vena cava superior (time frame: at 6 post-operative hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.