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CompletedNCT03301571ReVERSEUpdated Jan 9, 2018

Right Ventricular Echocardiography in caRdiac SurgEry

An interventional study of Change in preload and afterload and Inspired oxygen in Right Ventricular Dysfunction, sponsored by Rigshospitalet, Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-09.

Sponsored by Rigshospitalet, Denmark · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled May 2017, registered Sep 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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)).

Read the 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

02

Conditions studied

  • Right Ventricular Dysfunction

Keywords

  • Coronary artery bypass graft
  • Echocardiography
03

In context

Ventricular Dysfunction, Right

90 studies on the registry are indexed under Ventricular Dysfunction, Right; 28 are open to participants now.

This study's enrollment of 30 is below the median of 60 across 38 interventional studies indexed under Ventricular Dysfunction, Right.

Browse Ventricular Dysfunction, Right studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,007 studies on the registry; 175 are open to participants now.

Browse Rigshospitalet, Denmark studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Elective coronary artery bypass graft patients
  • Normal left ventricular function defined as over 50 % on TTE preoperatively

Exclusion criteria

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 to TEE probe placement such as oesophageal stricture or obstruction
  • Patients with contraindication to Swan-Ganz catheter placement
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Other
    All patients

    All patients will receive the treatment (CABG) and postoperatively three different interventions: 1. Change in preload and afterload 2. Change in inspired oxygen 3. Change in pacemaker modes

    Other: Change in preload and afterload · Other: Inspired oxygen · Other: Pacemaker mode

Interventions

  • OtherChange 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

  • OtherInspired oxygen

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

  • OtherPacemaker 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

06

What researchers measure

Primary outcomes

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

    Assessing the change in RV function during CABG surgery

    Time frame: During a standard CABG operation

Secondary outcomes

  1. Right ventricular function assessed with TAPSE after each intervention

    Change in TAPSE after each intervention

    Time frame: Immediate postoperative period

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

    Cardiac output measured with the thermodilution technique

    Time frame: During a standard CABG operation

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

    Cardiac output measured with the thermodilution technique

    Time frame: Immediate postoperative period

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

    Change in S'

    Time frame: Immediate postoperative period

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

    Change in S'

    Time frame: During a standard CABG operation

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

    Change in Tei index

    Time frame: Immediate postoperative period

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

    Change in Tei index

    Time frame: During a standard CABG operation

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

    Change in RVFAC

    Time frame: Immediate postoperative period

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

    Change in RVFAC

    Time frame: During a standard CABG operation

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

    Change in MAPSE

    Time frame: Immediate postoperative period

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

    Change in MAPSE

    Time frame: During a standard CABG operation

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

    Change in strain %

    Time frame: Immediate postoperative period

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

    Change in strain %

    Time frame: During a standard CABG operation

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

    Change in strain rate

    Time frame: Immediate postoperative period

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

    Change in strain rate

    Time frame: During a standard CABG operation

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

    Change in RV size

    Time frame: Immediate postoperative period

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

    Change in RV size

    Time frame: During a standard CABG operation

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

    Change in flow velocity in pulmonary artery

    Time frame: Immediate postoperative period

  19. Response in right ventricular function parameter pulmonary artery flow velocity during a standard CABG operation

    Change in flow velocity in pulmonary artery

    Time frame: During a standard CABG operation

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

    Change in RVEF measured with 3D echo

    Time frame: Immediate postoperative period

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

    Change in RVEF measured with 3D echo

    Time frame: During a standard CABG operation

  22. Response in right ventricular function parameter RVEF during CABG

    Change in RVEF measured with 3D echo

    Time frame: Immediate postoperative period

  23. 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.

    Time frame: During a standard CABG operation

  24. 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.

    Time frame: Immediate postoperative period

  25. 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

    Time frame: Immediate postoperative period

  26. 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

    Time frame: During a standard CABG operation

07

Study locations

1 site
  • Rigshospitalet
    Copenhagen, Capital Region 2100, Denmark
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from May 2017 to primary completion in Oct 2017, 5 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2017
First posted
Oct 4, 2017
StartActual
May 4, 2017
Primary completionActual
Oct 5, 2017
CompletionActual
Oct 5, 2017
Last update
Jan 9, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03301571
Lead sponsor
Rigshospitalet, Denmark
Responsible party
Lars Grønlykke (Principal investigator, MD, Rigshospitalet, Denmark) — Principal investigator
First posted
Oct 4, 2017
Start date
May 4, 2017
Primary completion
Oct 5, 2017
Completion
Oct 5, 2017
Last update
Jan 9, 2018

Study contacts

Lars Grønlykke, MD
principal investigator · Rigshospitalet, Denmark

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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