An interventional study of Pressure/Volume Combination Catheter and Transthoracic echocardiography in Coronary Surgery, sponsored by Pierre Wauthy. Completed at 1 site in Belgium. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-01-18.
Sponsored by Pierre Wauthy · Not applicable, Interventional, and Prevention
The interpretation of perioperative measures of cardiac function during cardiac surgery is complicated. In particular, the evaluation of the diastolic compliance of the left ventricle. In addition, they are subject to variations induced by post-charge changes caused by the anesthesia, extracorporeal circulation (ECC) and the surgical procedure itself.
Left ventricular failure is frequently measured by alteration of LV contractile properties, and very rarely by alteration of LV compliance. However, both contractility (systolic) and relaxation (diastolic) parameters are important for the left ventricle to perform its function adequately. Left ventricular failure after cardiac surgery with extracorporeal circulation and cardiac arrest under cardioplegia protection is an important and frequently reported complication. The investigator's objectives are to characterize the diastolic hemodynamic mechanisms of this left ventricular failure and to identify predictors of this failure in the postoperative period.
The quantification of the systolic and diastolic functions of the left ventricle by ventricular pressure-volume curves is the technique of reference today, because it allows to determine parameters that are independent of the pre- and post-load conditions. Previous studies using the conductance catheter for the purpose of estimating left ventricular function perioperatively are rare and report conflicting results. In addition, they were mainly intended to measure the systolic function of the left ventricle. Only one reported the diastolic relaxation parameters evaluated by a conductance catheter. This study showed immediately after withdrawal of the extracorporeal circulation a significant alteration of the diastolic relaxation of the left ventricle, but was not interested in its early (kinetic) evolution peroperatively.
The investigator's experience shows that, in the quarter-hour following the weaning of the extracorporeal circulation, a decrease in filling pressures of the left ventricle concomitant with an increase in cardiac output is objectified. These observations are consistent with a significant improvement in left ventricle compliance, but have never been reported.
The objectives of this study are:
Pierre Wauthy is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The study will be conducted at the CHU Brugmann Hospital, with collaboration between cardiac surgery and anesthesiology wards. Subjects referred for elective coronary surgery will be prospectively included during the length of the study.
Device: Pressure/Volume Combination Catheter · Device: Transthoracic echocardiography · Device: Transesophageal echocardiogram
Hemodynamic data routinely collected and data collected by means of the placement of a Pressure/Volume Combination Catheter (Pressure/Volume Combination Catheter,Leycom,The Netherlands) will be collected simultaneously. The catheter will be placed and held in place as long as the patient is in a position to be assisted by extracorporeal circulation. This means that the placement of the catheter will follow the heparinization of the patient and the placement of the cannulas necessary for the realization of extracorporal circulation. It will be removed from the left ventricular cavity before removal of extra-corporal cannulas.
A complete transthoracic echocardiography will be performed the day before the surgical procedure, as per standard of care. It will establish the presence of the inclusion and exclusion criteria and evaluate the contractile function of the left ventricle. This will be done using a Philips IE33 echocardiograph (Koninklijke Philips Electronics N.V., Netherlands).
A transesophageal echocardiogram will be performed during the cardiac surgery, as per standard of care, using an Acuson Sequoia system (Siemens AG, Germany). It will facilitate the placement of the pressure/volume combination catheter and collect echographic data.
Tele-systolic pressure of the left ventricle
Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.
Time frame: Baseline (before extracorporeal circulation is switched on)
Tele-systolic pressure of the left ventricle
Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.
Time frame: 1 minute after extracorporeal circulation is switched on
Tele-systolic pressure of the left ventricle
Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.
Time frame: 1 minute after extracorporeal circulation is stopped
Tele-systolic pressure of the left ventricle
Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.
Time frame: 10 minutes after extracorporeal circulation is stopped
Tele-systolic pressure of the left ventricle
Pressure within the left ventricle after the atrial contraction, at the beginning of the ventricular contraction.
Time frame: 20 minutes after extracorporeal circulation is stopped
Diastolic pressure of the left ventricle
The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.
Time frame: Baseline (before extracorporeal circulation is switched on)
Diastolic pressure of the left ventricle
The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.
Time frame: 1 minute after extracorporeal circulation is switched on
Diastolic pressure of the left ventricle
The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.
Time frame: 1 minute after extracorporeal circulation is stopped
Diastolic pressure of the left ventricle
The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.
Time frame: 10 minutes after extracorporeal circulation is stopped
Diastolic pressure of the left ventricle
The pressure within the left ventricle following the completion of diastolic filling, just prior to systole.
Time frame: 20 minutes after extracorporeal circulation is stopped
Tele-systolic volume of the left ventricle
At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.
Time frame: Baseline
Tele-systolic volume of the left ventricle
At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.
Time frame: 1 minute after extracorporeal circulation is switched on
Tele-systolic volume of the left ventricle
At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.
Time frame: 1 minute after extracorporeal circulation is stopped
Tele-systolic volume of the left ventricle
At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.
Time frame: 10 minutes after extracorporeal circulation is stopped
Tele-systolic volume of the left ventricle
At the end of systole, the ventricle contains a quantity of blood called 'telesystolic volume'.
Time frame: 20 minutes after extracorporeal circulation is stopped
Diastolic volume of the left ventricle
At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.
Time frame: Baseline
Diastolic volume of the left ventricle
At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.
Time frame: 1 minute after extracorporeal circulation is switched on
Diastolic volume of the left ventricle
At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.
Time frame: 1 minute after extracorporeal circulation is stopped
Diastolic volume of the left ventricle
At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.
Time frame: 10 minutes after extracorporeal circulation is stopped
Diastolic volume of the left ventricle
At the end of diastole, the ventricle contains a quantity of blood called end-diastolic volume.
Time frame: 20 minutes after extracorporeal circulation is stopped
Ejection volume of the left ventricle
The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.
Time frame: Baseline
Ejection volume of the left ventricle
The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.
Time frame: 1 minute after extracorporeal circulation is switched on
Ejection volume of the left ventricle
The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.
Time frame: 1 minute after extracorporeal circulation is stopped
Ejection volume of the left ventricle
The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.
Time frame: 10 minutes after extracorporeal circulation is stopped
Ejection volume of the left ventricle
The ejection volume is the difference between systolic and diastolic volume. It represents the amount of blood ejected at each contraction by the ventricle.
Time frame: 20 minutes after extracorporeal circulation is stopped
Contractility index of the left ventricle
Computed by the following formula: (dP/dt max)/P
Time frame: Baseline
Contractility index of the left ventricle
Computed by the following formula: (dP/dt max)/P
Time frame: 1 minute after extracorporeal circulation is switched on
Contractility index of the left ventricle
Computed by the following formula: (dP/dt max)/P
Time frame: 1 minute after extracorporeal circulation is stopped
Contractility index of the left ventricle
Computed by the following formula: (dP/dt max)/P
Time frame: 10 minutes after extracorporeal circulation is stopped
Contractility index of the left ventricle
Computed by the following formula: (dP/dt max)/P
Time frame: 20 minutes after extracorporeal circulation is stopped
Plan to share: No
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Pierre Wauthy