ReVERSE: Right Ventricular Echocardiography in caRdiac SurgEry

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Completed
• CT.gov ID: NCT03301571
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Actual Duration (Months): 5.1
• Patients Per Site Per Month: 5.9

Study Details

Study Description

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)).

Condition or Disease	Intervention/Treatment	Phase
Right Ventricular Dysfunction	Other: Change in preload and afterload; Other: Inspired oxygen; Other: Pacemaker mode	N/A

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: All patients will receive the same interventionsAll patients will receive the same interventions
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Response in Right Ventricular Function to Change in Afterload, Preload and Inspired Oxygen in Patients Undergoing Coronary Artery Bypass Graft Surgery
• Actual Study Start Date: May 4, 2017
• Actual Primary Completion Date: Oct 5, 2017
• Actual Study Completion Date: Oct 5, 2017

Arms and Interventions

Arm

Intervention/Treatment

Other: All patients All patients will receive the treatment (CABG) and postoperatively three different interventions: Change in preload and afterload Change in inspired oxygen Change in pacemaker modes

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

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Right ventricular function assessed with TAPSE after each intervention [Immediate postoperative period]

   Change in TAPSE after each intervention

2. Change in cardiac output measured with Swan-Ganz during CABG [During a standard CABG operation]

   Cardiac output measured with the thermodilution technique

3. Change in cardiac output measured with Swan-Ganz after each intervention [Immediate postoperative period]

   Cardiac output measured with the thermodilution technique

4. Response in right ventricular function parameter S' to each intervention [Immediate postoperative period]

   Change in S'

5. Response in right ventricular function parameter S' during CABG [During a standard CABG operation]

   Change in S'

6. Response in right ventricular function parameter Tei index to each intervention [Immediate postoperative period]

   Change in Tei index

7. Response in right ventricular function parameter Tei index during a standard CABG operation [During a standard CABG operation]

   Change in Tei index

8. Response in right ventricular function parameter RVFAC to each intervention [Immediate postoperative period]

   Change in RVFAC

9. Response in right ventricular function parameter RVFAC during a standard CABG operation [During a standard CABG operation]

   Change in RVFAC

10. Response in left ventricular function parameter MAPSE to each intervention [Immediate postoperative period]

    Change in MAPSE

11. Response in left ventricular function parameter MAPSE during a standard CABG operation [During a standard CABG operation]

    Change in MAPSE

12. Response in right ventricular function parameter strain % to each intervention [Immediate postoperative period]

    Change in strain %

13. Response in right ventricular function parameter strain % during a standard CABG operation [During a standard CABG operation]

    Change in strain %

14. Response in right ventricular function parameter strain rate to each intervention [Immediate postoperative period]

    Change in strain rate

15. Response in right ventricular function parameter strain rate during a standard CABG operation [During a standard CABG operation]

    Change in strain rate

16. Response in right ventricular function parameter RV size to each intervention [Immediate postoperative period]

    Change in RV size

17. Response in right ventricular function parameter RV size during a standard CABG operation [During a standard CABG operation]

    Change in RV size

18. Response in right ventricular function parameter pulmonary artery flow velocity to each intervention [Immediate postoperative period]

    Change in flow velocity in pulmonary artery

19. 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

20. Response in right ventricular function parameter RVEF to each intervention [Immediate postoperative period]

    Change in RVEF measured with 3D echo

21. Response in right ventricular function parameter RVEF during a standard CABG operation [During a standard CABG operation]

    Change in RVEF measured with 3D echo

22. Response in right ventricular function parameter RVEF during CABG [Immediate postoperative period]

    Change in RVEF measured with 3D echo

23. 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.

24. 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.

25. 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

26. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rigshospitalet	Copenhagen	Capital Region	Denmark	2100

Sponsors and Collaborators

• Rigshospitalet, Denmark

Investigators

• Principal Investigator: Lars Grønlykke, MD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lars Grønlykke, Principal investigator, MD, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT03301571
• Other Study ID Numbers: 17005565
• First Posted: Oct 4, 2017
• Last Update Posted: Jan 9, 2018
• Last Verified: Jan 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lars Grønlykke, Principal investigator, MD, Rigshospitalet, Denmark: Coronary artery bypass graft; Echocardiography
• Additional relevant MeSH terms: Ventricular Dysfunction; Ventricular Dysfunction, Right

Study Results

No Results Posted as of Jan 9, 2018