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Trial record 8 of 53 for:    mechanical ventilators AND mode | Recruiting, Not yet recruiting, Available Studies

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 (CourbePVC)

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ClinicalTrials.gov Identifier: NCT03295669
Recruitment Status : Recruiting
First Posted : September 28, 2017
Last Update Posted : September 28, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Brief 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.


Condition or disease
Heart Surgery Ultrasonography Right Ventricle Systolic Function

Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Other
Time Perspective: Prospective
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
Study Start Date : November 2016
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : November 2017



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to a cardiovascular ICU following heart surgery
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295669


Contacts
Contact: Claude GIRARD 03.80.29.35.28 ext +33 claude.girard@chu-dijon.fr

Locations
France
Chu Dijon Bourogne Recruiting
Dijon, France
Contact: Claude GIRARD    03 80 29 35 28 ext +33    claude.girard@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT03295669     History of Changes
Other Study ID Numbers: ELLOUZE 2016
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: September 28, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No