Quantification of Right Ventricular Function Using Simultaneous Transthoracic and Transoesophageal Echocardiography

Not Applicable

Withdrawn

• Conditions: Cardiac Surgery
• Interventions: Diagnostic Test: TTE and TOE

• Registration Number: NCT03954002
• Lead Sponsor: National University Hospital, Singapore

Brief Summary

The aims of this study are to evaluate the usefulness of various methods of quantifying right ventricular (RV) function using perioperative transoesophageal echocardiographic (TOE), compared with simultaneous transthoracic echocardiographic (TTE) findings.

Detailed Description

The hypothesis of this study that perioperative TOE is useful in quantifying RV function, and that the quantification methods used will correlate well to commonly used, well-studied TTE parameters obtained simultaneously, under the same loading conditions.

Assessment of RV function is of particular importance in the perioperative period. RV dysfunction can be due to a myriad of causes - myocardial ischemia, pulmonary embolism, pulmonary hypertension, congenital heart disease, or cardiomyopathy. The presence of RV failure can lead to difficulty in separation from cardiopulmonary bypass in cardiac surgical patients, and has been shown to be an independent predictor of mortality in high-risk cardiac surgery patients. Additionally, correct identification of RV dysfunction is crucial in order for the correct treatment to be administered. RV failure can lead to underfilling of the left ventricle, and mimic hypovolaemia with hypotension and an exaggerated stroke volume variation. In such a case, failure to diagnose RV dysfunction can wrongly lead to fluid loading and further worsening of right ventricular failure.

While evaluation of right heart function is well described in TTE studies, there is insufficient data at present to recommend a reliable method to quantify RV function using TTE.

In addition to traditional measurements of RV function, we hope to study the usefulness of speckle tracking and strain imaging in assessment of RV function, modalities of echocardiographic image analysis which have garnered increasing interest in recent years.

Study Timeline

• Study First Submitted: 2019-04-29
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-17
• Study Start: 2019-06-01
• Status Verified: 2021-10
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-27
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Age > 21 years
• Undergoing elective cardiac surgery
• Planned for intraoperative TOE

Exclusion Criteria

• Patient refusal
• Emergency surgery
• Haemodynamic instability
• Previous tricuspid valve surgery
• Severe tricuspid regurgitation
• Rhythm other than sinus
• Previous oesophageal / gastric surgery
• Oesophageal stricture / tumour
• Oesophageal diverticulum / fistula
• Active upper GI haemorrhage
• Oesophageal varices

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TTE and TOE	TTE and TOE	A small flexible tube (TOE probe) will be inserted into your oesophagus, or food pipe, to take images of your heart as per routine anaesthetic care for cardiac surgery. Just before and after general anaesthesia is administered, a short transthoracic echocardiography (TTE scan will be performed to acquire images of your heart. This is an ultrasound scan of your heart using a probe on the outside of the chest. During this period, relevant haemodynamic data such as blood pressure and heart rate will be recorded.

Primary Outcome Measures

Name	Time	Method
Data collection of views obtained from TTE	Intra-operatively during general anaesthesia	Evaluate the usefulness of various methods of quantifying right ventricular (RV) function using perioperative transoesophageal echocardiographic (TOE), compared with simultaneous transthoracic echocardiographic (TTE) findings.; The main data to be collected for TTE are: Pre-induction A4Ch (4 beats), Pre-induction M-mode (lateral TA), Post-induction A4Ch (4 beats), Post-induction M-mode (lateral TA), Post-induction TDI (lateral TA) (PWD)
Data collection of views obtained from TOE	Intra-operatively during general anaesthesia	Evaluate the usefulness of various methods of quantifying right ventricular (RV) function using perioperative transoesophageal echocardiographic (TOE), compared with simultaneous transthoracic echocardiographic (TTE) findings.; The main data to be collected for TOE are: RV focused ME4Ch (4 beats), M-mode (ME4Ch, lateral TA), TDI (ME4Ch, lateral TA) (PWD), Deep TG RV apical view (4 beats), M-mode (DTG, lateral TA), TDI (DTG, lateral TA) (PWD)

Trial Locations

Locations (1)

National University Health System; 🇸🇬 Singapore, Singapore