Clinical trial NCT03301571: Right Ventricular Echocardiography in caRdiac SurgEry
Official title: Response in Right Ventricular Function to Change in Afterload, Preload and Inspired Oxygen in Patients Undergoing Coronary Artery Bypass Graft Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Right Ventricular Dysfunction
Keywords: Coronary artery bypass graft
Echocardiography
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2017-10-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients will receive the same interventions
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in right ventricular function during CABG assessed with TAPSE
timeFrame: During a standard CABG operation
Secondary outcomes:
measure: Right ventricular function assessed with TAPSE after each intervention
timeFrame: Immediate postoperative period
measure: Change in cardiac output measured with Swan-Ganz during CABG
timeFrame: During a standard CABG operation
measure: Change in cardiac output measured with Swan-Ganz after each intervention
timeFrame: Immediate postoperative period
measure: Response in right ventricular function parameter S' to each intervention
timeFrame: Immediate postoperative period
measure: Response in right ventricular function parameter S' during CABG
timeFrame: During a standard CABG operation
measure: Response in right ventricular function parameter Tei index to each intervention
timeFrame: Immediate postoperative period
measure: Response in right ventricular function parameter Tei index during a standard CABG operation
timeFrame: During a standard CABG operation
measure: Response in right ventricular function parameter RVFAC to each intervention
timeFrame: Immediate postoperative period
measure: Response in right ventricular function parameter RVFAC during a standard CABG operation
timeFrame: During a standard CABG operation
measure: Response in left ventricular function parameter MAPSE to each intervention
timeFrame: Immediate postoperative period
measure: Response in left ventricular function parameter MAPSE during a standard CABG operation
timeFrame: During a standard CABG operation
measure: Response in right ventricular function parameter strain % to each intervention
timeFrame: Immediate postoperative period
measure: Response in right ventricular function parameter strain % during a standard CABG operation
timeFrame: During a standard CABG operation
measure: Response in right ventricular function parameter strain rate to each intervention
timeFrame: Immediate postoperative period
measure: Response in right ventricular function parameter strain rate during a standard CABG operation
timeFrame: During a standard CABG operation
measure: Response in right ventricular function parameter RV size to each intervention
timeFrame: Immediate postoperative period
measure: Response in right ventricular function parameter RV size during a standard CABG operation
timeFrame: During a standard CABG operation
measure: Response in right ventricular function parameter pulmonary artery flow velocity to each intervention
timeFrame: Immediate postoperative period
measure: Response in right ventricular function parameter pulmonary artery flow velocity during a standard CABG operation
timeFrame: During a standard CABG operation
measure: Response in right ventricular function parameter RVEF to each intervention
timeFrame: Immediate postoperative period
measure: Response in right ventricular function parameter RVEF during a standard CABG operation
timeFrame: During a standard CABG operation
measure: Response in right ventricular function parameter RVEF during CABG
timeFrame: Immediate postoperative period
measure: Change in cardiac output measured with Swan Ganz in response during a standard CABG operation
timeFrame: During a standard CABG operation
measure: Change in cardiac output measured with Swan Ganz in response to each intervention
timeFrame: Immediate postoperative period
measure: Change in hemodynamic pressures in response to each intervention
timeFrame: Immediate postoperative period
measure: Change in hemodynamic pressures during a standard CABG operation
timeFrame: During a standard CABG operation
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
state: Capital Region
Study officials:
affiliation: Rigshospitalet, Denmark
name: Lars Grønlykke, MD
role: PRINCIPAL_INVESTIGATOR
References: