Right Ventricular Dysfunction
Conditions
Keywords
Coronary artery bypass graft, Echocardiography
Brief summary
Postoperative right ventricular (RV) dysfunction increases mortality and risk of cardiac failure after cardiac surgery substantially. A comprehensive understanding of this condition is paramount in order to achieve success in treatment and early diagnosis. This study has two main aims. Perioperative aim: To investigate correlations between changes in echocardiographic measurements and hemodynamic changes at baseline and following coronary artery bypass graft (CABG) surgery. Postoperative aim: To evaluate changes in haemodynamics and echocardiographic parameters during separate physiological interventions (increase in preload/afterload, oxygen fraction, pacing modes (AAI/DDD/VVI)).
Detailed description
Clinical procedure: For the operation standard procedures for anaesthesia, surgery and cardiopulmonary bypass will be used. This includes installment of a pulmonary artery catheter and performing a transesophageal echocardiography. For the purpose of this study additional TEE images and a transthoracic echocardiography (TTE) will be obtained in order to correlate different echocardiographic indices with haemodynamic measurements and investigate any differences between TTE and TEE measurements. Transthoracic echocardiography (TTE): Basic TTE will be performed after anaesthesia induction, before surgery commences and repeated immediately after arrival at the ICU. Image acquisitions from TTE: * 2D apical 4-chamber view for right ventricular fractional area change (RVFAC) * M-mode tricuspid annular plane systolic excursion (TAPSE). * M-mode lateral mitral annular plane systolic excursion (MAPSE) measurements Transoesophageal echocardiography (TEE): After probe placement and before commencing surgery a TEE will be performed. The probe will be left in place during surgery for continuous imaging. Standard views used for patient treatment will be acquired in accordance with the requirements of the treating anaesthesiologist and surgeon. Additional views will be added in order to obtain standard 2D measures, M-mode measures, spectral doppler measures, myocardial doppler tissue imaging, strain and 3D measures of RV function. Measurements will be performed at different stages throughout surgery following a period of relative hemodynamic stability defined as: 1 minute of no more than 10 beats/min variation in heart rate, maximum variation of 10 mmHg in mean arterial pressure, maximum variation of 3 mmHg in central venous pressure and no change in administration of vasoactive drugs. If hemodynamic stability cannot be achieved an annotation comment will be entered. Time points for echocardiography: TEE will be performed at four different time points during and immediately after surgery: Stage 1: After induction of anaesthesia. Stage 2: After full sternotomy Stage 3: After completion of cardiopulmonary bypass Stage 4: Immediately after arrival at the ICU and will be repeated after each intervention Interventions Each intervention will be investigated separately and before each intervention the patient will return to hemodynamic baseline. Trendelenburg position for 5 minutes will be investigated. Following positive end-expiratory pressures will be investigated: 0 cm H2O, 5 cm H2O and 10 cm H2O. Following fractions of inspired O2 will be investigated: 0.5 and 1.0 for 10 minutes at each setting. Following pacemaker settings will be investigated: Atrioventricular pacing 10 bpm over the patients' intrinsic rhythm, atrial pacing 10 bpm over the patients' intrinsic rhythm, ventricular pacing 10 bpm over the patients' intrinsic rhythm
Interventions
OTHERChange in preload and afterload
Afterload: Three levels of positive end-expiratory pressure (PEEP) will be examined post-operatively: 0 cm H20, 5 cm H2O, 10 cm H2O Preload: Trendelenburg position for 5 minutes will be investigated
OTHERInspired oxygen
Following fractions of inspired O2 will be investigated: 0.5 and 1.0 for 10 minutes respectively
OTHERPacemaker mode
Following pacemaker settings will be investigated: Atrioventricular pacing 10 bpm over the patients' intrinsic rhythm, atrial pacing 10 bpm over the patients' intrinsic rhythm, ventricular pacing 10 bpm over the patients' intrinsic rhythm
Sponsors
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Intervention model description
All patients will receive the same interventions
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Elective coronary artery bypass graft patients * Normal left ventricular function defined as LVEF over 50 % on TTE preoperatively
Exclusion criteria
* Pre-existing right ventricular malformations * Severe right ventricular impairment preoperatively * Pre-existing non-sinus rhythm * Pre-existing mitral valve stenosis or severe regurgitation * Pre-existing pulmonary hypertension * Pre-existing tricuspid valve stenosis or severe regurgitation * Patients with contraindication to TEE probe placement such as oesophageal stricture or obstruction * Patients with contraindication to Swan-Ganz catheter placement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in right ventricular function during CABG assessed with TAPSE | During a standard CABG operation | Assessing the change in RV function during CABG surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in cardiac output measured with Swan-Ganz during CABG | During a standard CABG operation | Cardiac output measured with the thermodilution technique |
| Change in cardiac output measured with Swan-Ganz after each intervention | Immediate postoperative period | Cardiac output measured with the thermodilution technique |
| Response in right ventricular function parameter S' to each intervention | Immediate postoperative period | Change in S' |
| Response in right ventricular function parameter S' during CABG | During a standard CABG operation | Change in S' |
| Response in right ventricular function parameter Tei index to each intervention | Immediate postoperative period | Change in Tei index |
| Response in right ventricular function parameter Tei index during a standard CABG operation | During a standard CABG operation | Change in Tei index |
| Response in right ventricular function parameter RVFAC to each intervention | Immediate postoperative period | Change in RVFAC |
| Response in right ventricular function parameter RVFAC during a standard CABG operation | During a standard CABG operation | Change in RVFAC |
| Response in left ventricular function parameter MAPSE to each intervention | Immediate postoperative period | Change in MAPSE |
| Response in left ventricular function parameter MAPSE during a standard CABG operation | During a standard CABG operation | Change in MAPSE |
| Response in right ventricular function parameter strain % to each intervention | Immediate postoperative period | Change in strain % |
| Response in right ventricular function parameter strain % during a standard CABG operation | During a standard CABG operation | Change in strain % |
| Right ventricular function assessed with TAPSE after each intervention | Immediate postoperative period | Change in TAPSE after each intervention |
| Response in right ventricular function parameter strain rate during a standard CABG operation | During a standard CABG operation | Change in strain rate |
| Response in right ventricular function parameter RV size to each intervention | Immediate postoperative period | Change in RV size |
| Response in right ventricular function parameter RV size during a standard CABG operation | During a standard CABG operation | Change in RV size |
| Response in right ventricular function parameter pulmonary artery flow velocity to each intervention | Immediate postoperative period | Change in flow velocity in pulmonary artery |
| Response in right ventricular function parameter pulmonary artery flow velocity during a standard CABG operation | During a standard CABG operation | Change in flow velocity in pulmonary artery |
| Response in right ventricular function parameter RVEF to each intervention | Immediate postoperative period | Change in RVEF measured with 3D echo |
| Response in right ventricular function parameter RVEF during a standard CABG operation | During a standard CABG operation | Change in RVEF measured with 3D echo |
| Response in right ventricular function parameter RVEF during CABG | Immediate postoperative period | Change in RVEF measured with 3D echo |
| Change in cardiac output measured with Swan Ganz in response during a standard CABG operation | During a standard CABG operation | Following each intervention in the postoperative period cardiac output will be measured with the thermodilution technique. |
| Change in cardiac output measured with Swan Ganz in response to each intervention | Immediate postoperative period | Following each intervention in the postoperative period cardiac output will be measured with the thermodilution technique. |
| Change in hemodynamic pressures in response to each intervention | Immediate postoperative period | Following each intervention in the postoperative period hemodynamic pressures will be measured with the Swan Ganz catheter |
| Change in hemodynamic pressures during a standard CABG operation | During a standard CABG operation | Following each intervention in the postoperative period hemodynamic pressures will be measured with the Swan Ganz catheter |
| Response in right ventricular function parameter strain rate to each intervention | Immediate postoperative period | Change in strain rate |
Countries
Denmark
Outcome results
None listed