Right Ventricular Echocardiography in caRdiac SurgEry

NCT03301571 | Completed

• 1 other identifier: 17005565
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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)).

Conditions

Right Ventricular Dysfunction

Keywords

Coronary artery bypass graft; Echocardiography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (26)

• Right ventricular function assessed with TAPSE after each intervention

  Immediate postoperative period

• Change in cardiac output measured with Swan-Ganz during CABG

  During a standard CABG operation

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

  Immediate postoperative period

• Response in right ventricular function parameter S' to each intervention

  Immediate postoperative period

• Response in right ventricular function parameter S' during CABG

  During a standard CABG operation

Study Arms (1)

All patients

OTHER

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

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

All patients

Inspired oxygen OTHER

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

All patients

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

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead

Study Sites (1)

Rigshospitalet

Copenhagen, Capital Region, 2100, Denmark

Location

MeSH Terms

Conditions

Ventricular Dysfunction, Right

Condition Hierarchy (Ancestors)

Ventricular Dysfunction; Heart Diseases; Cardiovascular Diseases

Study Officials

• Lars Grønlykke, MD

  Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, MD

Model Details: All patients will receive the same interventions

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: October 4, 2017
• Study Start: May 4, 2017
• Primary Completion: October 5, 2017
• Study Completion: October 5, 2017
• Last Updated: January 9, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)