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Completed

NCT Number: NCT03301571

Right Ventricular Echocardiography in caRdiac SurgEry

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)).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Change in preload and afterload

Other

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

Other

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

Pacemaker mode

Other

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

Primary outcomes

  1. Change in right ventricular function during CABG assessed with TAPSE

    Time frame: During a standard CABG operation

    Assessing the change in RV function during CABG surgery

Secondary outcomes

  1. Right ventricular function assessed with TAPSE after each intervention

    Time frame: Immediate postoperative period

    Change in TAPSE after each intervention

  2. Change in cardiac output measured with Swan-Ganz during CABG

    Time frame: During a standard CABG operation

    Cardiac output measured with the thermodilution technique

  3. Change in cardiac output measured with Swan-Ganz after each intervention

    Time frame: Immediate postoperative period

    Cardiac output measured with the thermodilution technique

  4. Response in right ventricular function parameter S' to each intervention

    Time frame: Immediate postoperative period

    Change in S'

  5. Response in right ventricular function parameter S' during CABG

    Time frame: During a standard CABG operation

    Change in S'

  6. Response in right ventricular function parameter Tei index to each intervention

    Time frame: Immediate postoperative period

    Change in Tei index

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

    Time frame: During a standard CABG operation

    Change in Tei index

  8. Response in right ventricular function parameter RVFAC to each intervention

    Time frame: Immediate postoperative period

    Change in RVFAC

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

    Time frame: During a standard CABG operation

    Change in RVFAC

  10. Response in left ventricular function parameter MAPSE to each intervention

    Time frame: Immediate postoperative period

    Change in MAPSE

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

    Time frame: During a standard CABG operation

    Change in MAPSE

  12. Response in right ventricular function parameter strain % to each intervention

    Time frame: Immediate postoperative period

    Change in strain %

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

    Time frame: During a standard CABG operation

    Change in strain %

  14. Response in right ventricular function parameter strain rate to each intervention

    Time frame: Immediate postoperative period

    Change in strain rate

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

    Time frame: During a standard CABG operation

    Change in strain rate

  16. Response in right ventricular function parameter RV size to each intervention

    Time frame: Immediate postoperative period

    Change in RV size

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

    Time frame: During a standard CABG operation

    Change in RV size

  18. Response in right ventricular function parameter pulmonary artery flow velocity to each intervention

    Time frame: 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

    Time frame: During a standard CABG operation

    Change in flow velocity in pulmonary artery

  20. Response in right ventricular function parameter RVEF to each intervention

    Time frame: Immediate postoperative period

    Change in RVEF measured with 3D echo

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

    Time frame: During a standard CABG operation

    Change in RVEF measured with 3D echo

  22. Response in right ventricular function parameter RVEF during CABG

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: During a standard CABG operation

    Following each intervention in the postoperative period hemodynamic pressures will be measured with the Swan Ganz catheter

Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Registry information

Official study title

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

Acronym: ReVERSE

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Oct 4, 2017
Registry last updated
Jan 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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