Right Ventricular Echocardiography in caRdiac SurgEry

Right Ventricular Dysfunction Clinical Trial

— ReVERSE  

Official title:

Response in Right Ventricular Function to Change in Afterload, Preload and Inspired Oxygen in Patients Undergoing Coronary Artery Bypass Graft Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03301571
• Other study ID #: 17005565
• Status: Completed
• Phase: N/A
• First received: September 19, 2017
• Last updated: January 8, 2018
• Start date: May 4, 2017
• Est. completion date: October 5, 2017

Study information

• Verified date: January 2018
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 5, 2017
• Est. primary completion date: October 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Right Ventricular Dysfunction
• Ventricular Dysfunction
• Ventricular Dysfunction, Right

Intervention

Other:
• Change 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
• Inspired oxygen
Following fractions of inspired O2 will be investigated: 0.5 and 1.0 for 10 minutes respectively
• Pacemaker 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

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen	Capital Region

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in right ventricular function during CABG assessed with TAPSE	Assessing the change in RV function during CABG surgery	During a standard CABG operation
Secondary	Right ventricular function assessed with TAPSE after each intervention	Change in TAPSE after each intervention	Immediate postoperative period
Secondary	Change in cardiac output measured with Swan-Ganz during CABG	Cardiac output measured with the thermodilution technique	During a standard CABG operation
Secondary	Change in cardiac output measured with Swan-Ganz after each intervention	Cardiac output measured with the thermodilution technique	Immediate postoperative period
Secondary	Response in right ventricular function parameter S' to each intervention	Change in S'	Immediate postoperative period
Secondary	Response in right ventricular function parameter S' during CABG	Change in S'	During a standard CABG operation
Secondary	Response in right ventricular function parameter Tei index to each intervention	Change in Tei index	Immediate postoperative period
Secondary	Response in right ventricular function parameter Tei index during a standard CABG operation	Change in Tei index	During a standard CABG operation
Secondary	Response in right ventricular function parameter RVFAC to each intervention	Change in RVFAC	Immediate postoperative period
Secondary	Response in right ventricular function parameter RVFAC during a standard CABG operation	Change in RVFAC	During a standard CABG operation
Secondary	Response in left ventricular function parameter MAPSE to each intervention	Change in MAPSE	Immediate postoperative period
Secondary	Response in left ventricular function parameter MAPSE during a standard CABG operation	Change in MAPSE	During a standard CABG operation
Secondary	Response in right ventricular function parameter strain % to each intervention	Change in strain %	Immediate postoperative period
Secondary	Response in right ventricular function parameter strain % during a standard CABG operation	Change in strain %	During a standard CABG operation
Secondary	Response in right ventricular function parameter strain rate to each intervention	Change in strain rate	Immediate postoperative period
Secondary	Response in right ventricular function parameter strain rate during a standard CABG operation	Change in strain rate	During a standard CABG operation
Secondary	Response in right ventricular function parameter RV size to each intervention	Change in RV size	Immediate postoperative period
Secondary	Response in right ventricular function parameter RV size during a standard CABG operation	Change in RV size	During a standard CABG operation
Secondary	Response in right ventricular function parameter pulmonary artery flow velocity to each intervention	Change in flow velocity in pulmonary artery	Immediate postoperative period
Secondary	Response in right ventricular function parameter pulmonary artery flow velocity during a standard CABG operation	Change in flow velocity in pulmonary artery	During a standard CABG operation
Secondary	Response in right ventricular function parameter RVEF to each intervention	Change in RVEF measured with 3D echo	Immediate postoperative period
Secondary	Response in right ventricular function parameter RVEF during a standard CABG operation	Change in RVEF measured with 3D echo	During a standard CABG operation
Secondary	Response in right ventricular function parameter RVEF during CABG	Change in RVEF measured with 3D echo	Immediate postoperative period
Secondary	Change in cardiac output measured with Swan Ganz in response during a standard CABG operation	Following each intervention in the postoperative period cardiac output will be measured with the thermodilution technique.	During a standard CABG operation
Secondary	Change in cardiac output measured with Swan Ganz in response to each intervention	Following each intervention in the postoperative period cardiac output will be measured with the thermodilution technique.	Immediate postoperative period
Secondary	Change in hemodynamic pressures in response to each intervention	Following each intervention in the postoperative period hemodynamic pressures will be measured with the Swan Ganz catheter	Immediate postoperative period
Secondary	Change in hemodynamic pressures during a standard CABG operation	Following each intervention in the postoperative period hemodynamic pressures will be measured with the Swan Ganz catheter	During a standard CABG operation