Quantification of Right Ventricular Function Using Simultaneous Transthoracic and Transoesophageal Echocardiography

Cardiac Surgery Clinical Trial

Official title:

Quantification of Right Ventricular Function Using Simultaneous Transthoracic and Transoesophageal Echocardiography

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03954002
• Other study ID #: 2018/00987
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2021
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

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.

Locations

Country	Name	City	State
Singapore	National University Health System	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (7)

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. — View Citation

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. — View Citation

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

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. Erratum In: J Am Soc Echocardiogr. 2009 Aug;22(8):889. — View Citation

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. doi: 10.1097/ALN.0b013e318269054b. — View Citation

Korshin A, Gronlykke L, Nilsson JC, Moller-Sorensen H, Ihlemann N, Kjoller 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data collection of views obtained from TTE	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)	Intra-operatively during general anaesthesia
Primary	Data collection of views obtained from TOE	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)	Intra-operatively during general anaesthesia