Right Ventricular Echocardiography in caRdiac SurgEry (ReVERSE)
Primary Purpose
Right Ventricular Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Change in preload and afterload
Inspired oxygen
Pacemaker mode
Sponsored by
About this trial
This is an interventional basic science trial for Right Ventricular Dysfunction focused on measuring Coronary artery bypass graft, Echocardiography
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
Sites / Locations
- Rigshospitalet
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All patients
Arm Description
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
Outcomes
Primary Outcome Measures
Change in right ventricular function during CABG assessed with TAPSE
Assessing the change in RV function during CABG surgery
Secondary Outcome Measures
Right ventricular function assessed with TAPSE after each intervention
Change in TAPSE after each intervention
Change in cardiac output measured with Swan-Ganz during CABG
Cardiac output measured with the thermodilution technique
Change in cardiac output measured with Swan-Ganz after each intervention
Cardiac output measured with the thermodilution technique
Response in right ventricular function parameter S' to each intervention
Change in S'
Response in right ventricular function parameter S' during CABG
Change in S'
Response in right ventricular function parameter Tei index to each intervention
Change in Tei index
Response in right ventricular function parameter Tei index during a standard CABG operation
Change in Tei index
Response in right ventricular function parameter RVFAC to each intervention
Change in RVFAC
Response in right ventricular function parameter RVFAC during a standard CABG operation
Change in RVFAC
Response in left ventricular function parameter MAPSE to each intervention
Change in MAPSE
Response in left ventricular function parameter MAPSE during a standard CABG operation
Change in MAPSE
Response in right ventricular function parameter strain % to each intervention
Change in strain %
Response in right ventricular function parameter strain % during a standard CABG operation
Change in strain %
Response in right ventricular function parameter strain rate to each intervention
Change in strain rate
Response in right ventricular function parameter strain rate during a standard CABG operation
Change in strain rate
Response in right ventricular function parameter RV size to each intervention
Change in RV size
Response in right ventricular function parameter RV size during a standard CABG operation
Change in RV size
Response in right ventricular function parameter pulmonary artery flow velocity to each intervention
Change in flow velocity in pulmonary artery
Response in right ventricular function parameter pulmonary artery flow velocity during a standard CABG operation
Change in flow velocity in pulmonary artery
Response in right ventricular function parameter RVEF to each intervention
Change in RVEF measured with 3D echo
Response in right ventricular function parameter RVEF during a standard CABG operation
Change in RVEF measured with 3D echo
Response in right ventricular function parameter RVEF during CABG
Change in RVEF measured with 3D echo
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.
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.
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
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
Full Information
NCT ID
NCT03301571
First Posted
September 19, 2017
Last Updated
January 8, 2018
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT03301571
Brief Title
Right Ventricular Echocardiography in caRdiac SurgEry
Acronym
ReVERSE
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
May 4, 2017 (Actual)
Primary Completion Date
October 5, 2017 (Actual)
Study Completion Date
October 5, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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)).
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Ventricular Dysfunction
Keywords
Coronary artery bypass graft, Echocardiography
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients will receive the same interventions
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
All patients
Arm Type
Other
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Change in preload and afterload
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Inspired oxygen
Intervention Description
Following fractions of inspired O2 will be investigated: 0.5 and 1.0 for 10 minutes respectively
Intervention Type
Other
Intervention Name(s)
Pacemaker mode
Intervention Description
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 Outcome Measure Information:
Title
Change in right ventricular function during CABG assessed with TAPSE
Description
Assessing the change in RV function during CABG surgery
Time Frame
During a standard CABG operation
Secondary Outcome Measure Information:
Title
Right ventricular function assessed with TAPSE after each intervention
Description
Change in TAPSE after each intervention
Time Frame
Immediate postoperative period
Title
Change in cardiac output measured with Swan-Ganz during CABG
Description
Cardiac output measured with the thermodilution technique
Time Frame
During a standard CABG operation
Title
Change in cardiac output measured with Swan-Ganz after each intervention
Description
Cardiac output measured with the thermodilution technique
Time Frame
Immediate postoperative period
Title
Response in right ventricular function parameter S' to each intervention
Description
Change in S'
Time Frame
Immediate postoperative period
Title
Response in right ventricular function parameter S' during CABG
Description
Change in S'
Time Frame
During a standard CABG operation
Title
Response in right ventricular function parameter Tei index to each intervention
Description
Change in Tei index
Time Frame
Immediate postoperative period
Title
Response in right ventricular function parameter Tei index during a standard CABG operation
Description
Change in Tei index
Time Frame
During a standard CABG operation
Title
Response in right ventricular function parameter RVFAC to each intervention
Description
Change in RVFAC
Time Frame
Immediate postoperative period
Title
Response in right ventricular function parameter RVFAC during a standard CABG operation
Description
Change in RVFAC
Time Frame
During a standard CABG operation
Title
Response in left ventricular function parameter MAPSE to each intervention
Description
Change in MAPSE
Time Frame
Immediate postoperative period
Title
Response in left ventricular function parameter MAPSE during a standard CABG operation
Description
Change in MAPSE
Time Frame
During a standard CABG operation
Title
Response in right ventricular function parameter strain % to each intervention
Description
Change in strain %
Time Frame
Immediate postoperative period
Title
Response in right ventricular function parameter strain % during a standard CABG operation
Description
Change in strain %
Time Frame
During a standard CABG operation
Title
Response in right ventricular function parameter strain rate to each intervention
Description
Change in strain rate
Time Frame
Immediate postoperative period
Title
Response in right ventricular function parameter strain rate during a standard CABG operation
Description
Change in strain rate
Time Frame
During a standard CABG operation
Title
Response in right ventricular function parameter RV size to each intervention
Description
Change in RV size
Time Frame
Immediate postoperative period
Title
Response in right ventricular function parameter RV size during a standard CABG operation
Description
Change in RV size
Time Frame
During a standard CABG operation
Title
Response in right ventricular function parameter pulmonary artery flow velocity to each intervention
Description
Change in flow velocity in pulmonary artery
Time Frame
Immediate postoperative period
Title
Response in right ventricular function parameter pulmonary artery flow velocity during a standard CABG operation
Description
Change in flow velocity in pulmonary artery
Time Frame
During a standard CABG operation
Title
Response in right ventricular function parameter RVEF to each intervention
Description
Change in RVEF measured with 3D echo
Time Frame
Immediate postoperative period
Title
Response in right ventricular function parameter RVEF during a standard CABG operation
Description
Change in RVEF measured with 3D echo
Time Frame
During a standard CABG operation
Title
Response in right ventricular function parameter RVEF during CABG
Description
Change in RVEF measured with 3D echo
Time Frame
Immediate postoperative period
Title
Change in cardiac output measured with Swan Ganz in response during a standard CABG operation
Description
Following each intervention in the postoperative period cardiac output will be measured with the thermodilution technique.
Time Frame
During a standard CABG operation
Title
Change in cardiac output measured with Swan Ganz in response to each intervention
Description
Following each intervention in the postoperative period cardiac output will be measured with the thermodilution technique.
Time Frame
Immediate postoperative period
Title
Change in hemodynamic pressures in response to each intervention
Description
Following each intervention in the postoperative period hemodynamic pressures will be measured with the Swan Ganz catheter
Time Frame
Immediate postoperative period
Title
Change in hemodynamic pressures during a standard CABG operation
Description
Following each intervention in the postoperative period hemodynamic pressures will be measured with the Swan Ganz catheter
Time Frame
During a standard CABG operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Grønlykke, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rigshospitalet
City
Copenhagen
State/Province
Capital Region
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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Right Ventricular Echocardiography in caRdiac SurgEry
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