Quantification of Right Ventricular Function Using Simultaneous Transthoracic and Transoesophageal Echocardiography

• ClinicalTrials.gov Identifier: NCT03954002
• Recruitment Status: Active, not recruiting
• First Posted: May 17, 2019
• Last Update Posted: October 19, 2021
• Sponsor: National University Hospital, Singapore
• Information provided by (Responsible Party): National University Hospital, Singapore

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiac Surgery	Diagnostic Test: TTE and TOE	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 90 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Quantification of Right Ventricular Function Using Simultaneous Transthoracic and Transoesophageal Echocardiography
• Actual Study Start Date: June 1, 2019
• Estimated Primary Completion Date: December 31, 2021
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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.

Diagnostic Test: 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.

Outcome Measures

Primary Outcome Measures :

1. Data collection of views obtained from TTE [ Time Frame: 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)

2. Data collection of views obtained from TOE [ Time Frame: 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)

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Singapore

National University Health System

Singapore, Singapore, 119074

Sponsors and Collaborators

National University Hospital, Singapore

Investigators

• Principal Investigator: Chang Chuan Melvin Lee, MBBS, MMed; National University Health System

More Information

Publications:

Flo Forner A, Hasheminejad E, Sabate S, Ackermann MA, Turton EW, Ender J. Agreement of tricuspid annular systolic excursion measurement between transthoracic and transesophageal echocardiography in the perioperative setting. Int J Cardiovasc Imaging. 2017 Sep;33(9):1385-1394. doi: 10.1007/s10554-017-1128-9. Epub 2017 Apr 13.

Korshin A, Grønlykke L, Nilsson JC, Møller-Sørensen H, Ihlemann N, Kjøller M, Damgaard S, Lehnert P, Hassager C, Kjaergaard J, Ravn HB. The feasibility of tricuspid annular plane systolic excursion performed by transesophageal echocardiography throughout heart surgery and its interchangeability with transthoracic echocardiography. Int J Cardiovasc Imaging. 2018 Jul;34(7):1017-1028. doi: 10.1007/s10554-018-1306-4. Epub 2018 Jan 30.

Tousignant C, Kim H, Papa F, Mazer CD. Evaluation of TAPSE as a measure of right ventricular output. Can J Anaesth. 2012 Apr;59(4):376-83. doi: 10.1007/s12630-011-9659-3.

Bartels K, Karhausen J, Sullivan BL, Mackensen GB. Update on perioperative right heart assessment using transesophageal echocardiography. Semin Cardiothorac Vasc Anesth. 2014 Dec;18(4):341-51. doi: 10.1177/1089253214522326. Epub 2014 Feb 13. Review.

Kasper J, Bolliger D, Skarvan K, Buser P, Filipovic M, Seeberger MD. Additional cross-sectional transesophageal echocardiography views improve perioperative right heart assessment. Anesthesiology. 2012 Oct;117(4):726-34.

Horton KD, Meece RW, Hill JC. Assessment of the right ventricle by echocardiography: a primer for cardiac sonographers. J Am Soc Echocardiogr. 2009 Jul;22(7):776-92; quiz 861-2. doi: 10.1016/j.echo.2009.04.027. Review. Erratum in: J Am Soc Echocardiogr. 2009 Aug;22(8):889.

Forner FA, Hasheminejad E, Dobrovie M, Da Rocha e Silva J, Ender J. Agreement of tricuspid annular systolic excursion (TAPSE) measurement in m-mode between transthoracic (TTE) and transoesophageal (TOE) echocardiography. J Cardiothorac Vasc Anesth 2015; 29 (S2):S31-S58 OP-005

• Responsible Party: National University Hospital, Singapore
• ClinicalTrials.gov Identifier: NCT03954002
• Other Study ID Numbers: 2018/00987
• First Posted: May 17, 2019
• Last Update Posted: October 19, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National University Hospital, Singapore:

Transthoracic Echocardiography (TTE); Transoesophageal Echocardiography (TOE)