Heart SurgeryCourbePVCNCT03295669
Continuous Monitoring of Right Ventricular Function, Based on the Correlation Between the C-X Segment of the Central Venous Pressure Curve, and the Echocardiographic Evaluation of Right Ventricular Systolic Function
An observational study of Heart Surgery and Ultrasonography Right Ventricle Systolic Function, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Close analysis of right ventricular function is still not done by all clinicians, even though it is indispensable; notably in cardiovascular ICUs. Right ventricular dysfunction is responsible for increased morbidity and marks a turning point in the patient's prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Surgery, Ultrasonography Right Ventricle Systolic Function
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2016to 2 Nov 2017
- 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 admitted to a cardiovascular ICU following heart surgery
Who may be able to join
- Patients admitted to the cardiovascular ICU
- Patients with spontaneous breathing
- With a central venous catheter placed in the internal jugular vein and for whom the central venous pressure curve is exploitable
- With a US window allowing a 4-chamber view making it possible to calculate the right ventricle ejection fraction (Peak of the S' wave, of the TAPSE, Strain of the right ventricle)
Who cannot join
- Non-echogenic patients or those without an exploitable US window
- Patients without a central venous catheter in the internal jugular vein
- Patients with an unexploitable central venous pressure curve
Trial locations and contacts
1 site in 1 country.
About this study
Close analysis of right ventricular function is still not done by all clinicians, even though it is indispensable; notably in cardiovascular ICUs.
Right ventricular dysfunction is responsible for increased morbidity and marks a turning point in the patient's prognosis.
Read more
It is difficult to analyse, and is principally assessed using echocardiography and by measuring the peak of the S' wave with pulsed Doppler and by measuring the tricuspid annular plane systolic excursion (TAPSE) in the TM mode. New studies have shown the interest of using 2D strain as a marker of systolic and diastolic function of the right ventricle. Finally, the use of 3D ultrasound seems to be more reliable than cardiac MRI for fine analysis of the right ventricle, even though it is rarely used in routine practice.
Study of the right ventricle using ultrasonography alone requires experienced and available operators for closely repeated evaluations making it possible to detect right ventricle dysfunction quickly.
US monitoring of left and right heart function is done systematically and repeatedly during post-operative care following heart surgery. This US evaluation could be optimized by finding a way to monitor the right ventricle continuously.
From a physiological point of view, we know about the tight relationship between the aspect of the central venous pressure curve and more precisely the C-X segment (tricuspid bulging into the atrium and start of contraction of the right ventricle) and right ventricular function. We wish to analyse this segment, combined with a US evaluation, and to look for a possible correlation so as to allow continuous, easy-to-interpret monitoring of right ventricular systolic function.
This will be facilitated by the systematic presence of a central venous catheter in every patient undergoing heart surgery, thus allowing central venous pressure to be monitored.
To this end, we wish to collect different data from patients in the cardiovascular ICU, especially the central venous pressure curve, the ventilatory pressure curve and settings of the respirator, and to carry out an echography evaluation of each patient.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the peak of the S' wave
Measured: At baseline
Measure the tricuspid annular plane systolic excursion (TAPSE)
Measured: At baseline
Calculate strain in the right ventricle
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2017
- Study start2 Nov 2016
- Primary completion2 Nov 2017
- Study completion2 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart SurgeryStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295669
- Sponsor's protocol ID
- ELLOUZE 2016
- Acronym
- CourbePVC
- Status last verified
- Sep 2017
- First submitted
- 25 Sep 2017
- Last updated
- 28 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Monitoring of Right Ventricular Function, Based on the Correlation Between the C-X Segment of the Central Venous Pressure Curve, and the Echocardiographic Evaluation of Right Ventricular Systolic Function
- ClinicalTrials.gov ID
- NCT03295669
- Acronym / sponsor ID
- CourbePVC / ELLOUZE 2016
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 2 Nov 2016 (actual)
- Primary completion
- 2 Nov 2017 (actual)
- Study completion
- 2 Nov 2017 (actual)
- First posted
- 28 Sep 2017 (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.
Close analysis of right ventricular function is still not done by all clinicians, even though it is indispensable; notably in cardiovascular ICUs.
Right ventricular dysfunction is responsible for increased morbidity and marks a turning point in the patient's prognosis.
It is difficult to analyse, and is principally assessed using echocardiography and by measuring the peak of the S' wave with pulsed Doppler and by measuring the tricuspid annular plane systolic excursion (TAPSE) in the TM mode. New studies have shown the interest of using 2D strain as a marker of systolic and diastolic function of the right ventricle. Finally, the use of 3D ultrasound seems to be more reliable than cardiac MRI for fine analysis of the right ventricle, even though it is rarely used in routine practice.
Study of the right ventricle using ultrasonography alone requires experienced and available operators for closely repeated evaluations making it possible to detect right ventricle dysfunction quickly.
US monitoring of left and right heart function is done systematically and repeatedly during post-operative care following heart surgery. This US evaluation could be optimized by finding a way to monitor the right ventricle continuously.
From a physiological point of view, we know about the tight relationship between the aspect of the central venous pressure curve and more precisely the C-X segment (tricuspid bulging into the atrium and start of contraction of the right ventricle) and right ventricular function. We wish to analyse this segment, combined with a US evaluation, and to look for a possible correlation so as to allow continuous, easy-to-interpret monitoring of right ventricular systolic function.
This will be facilitated by the systematic presence of a central venous catheter in every patient undergoing heart surgery, thus allowing central venous pressure to be monitored.
To this end, we wish to collect different data from patients in the cardiovascular ICU, especially the central venous pressure curve, the ventilatory pressure curve and settings of the respirator, and to carry out an echography evaluation of each patient.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to a cardiovascular ICU following heart surgery
Key inclusion criteria (4 listed)
- Patients admitted to the cardiovascular ICU
- Patients with spontaneous breathing
- With a central venous catheter placed in the internal jugular vein and for whom the central venous pressure curve is exploitable
- With a US window allowing a 4-chamber view making it possible to calculate the right ventricle ejection fraction (Peak of the S' wave, of the TAPSE, Strain of the right ventricle)
Key exclusion criteria (3 listed)
- Non-echogenic patients or those without an exploitable US window
- Patients without a central venous catheter in the internal jugular vein
- Patients with an unexploitable central venous pressure curve
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure the peak of the S' wave
Time frame: At baseline
Measure the tricuspid annular plane systolic excursion (TAPSE)
Time frame: At baseline
Calculate strain in the right ventricle
Time frame: At baseline
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 28 Feb 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Heart Surgery and Ultrasonography Right Ventricle Systolic Function, run by Centre Hospitalier Universitaire Dijon 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 4 inclusion and 3 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 28 Feb 2023. 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?
Measure the peak of the S' wave (time frame: At baseline). The study lists 3 primary outcomes in all. 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 28 Feb 2023.