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CompletedNCT03295669CourbePVCUpdated Feb 28, 2023

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 in Heart Surgery and Ultrasonography Right Ventricle Systolic Function, sponsored by Centre Hospitalier Universitaire Dijon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-28.

Sponsored by Centre Hospitalier Universitaire Dijon · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Heart Surgery
  • Ultrasonography Right Ventricle Systolic Function

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients admitted to a cardiovascular ICU following heart surgery

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
250 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Measure the peak of the S' wave

    Time frame: At baseline

  2. Measure the tricuspid annular plane systolic excursion (TAPSE)

    Time frame: At baseline

  3. Calculate strain in the right ventricle

    Time frame: At baseline

06

Study locations

1 site
  • Chu Dijon Bourogne
    Dijon, France
07

Registry details

Key details

Study ID
NCT03295669
Lead sponsor
Centre Hospitalier Universitaire Dijon
Responsible party
Sponsor
First posted
Sep 28, 2017
Start date
Nov 2, 2016
Primary completion
Nov 2, 2017
Completion
Nov 2, 2017
Last update
Feb 28, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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