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出境医 / 临床实验 / Quantification of Right Ventricular Function Using Simultaneous Transthoracic and Transoesophageal Echocardiography

Quantification of Right Ventricular Function Using Simultaneous Transthoracic and Transoesophageal Echocardiography

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 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
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : June 1, 2020
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
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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

Contacts
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Contact: Chang Chuan Melvin Lee, MBBS, MMed 67724208 melvin_cc_lee@nuhs.edu.sg

Locations
Layout table for location information
Singapore
National University Health System
Singapore, Singapore, 119074
Contact: Chang Chuan Melvin Lee, MBBS, MMed    67724208    melvin_cc_lee@nuhs.edu.sg   
Sub-Investigator: Lian Kah Ti, MBBS, MMed         
Sub-Investigator: Suresh Paranjothy, MBBS, FRCA         
Sub-Investigator: Lalitha Manickam, MBBS, FRCA         
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Layout table for investigator information
Principal Investigator: Chang Chuan Melvin Lee, MBBS, MMed National University Health System
Tracking Information
First Submitted Date  ICMJE April 29, 2019
First Posted Date  ICMJE May 17, 2019
Last Update Posted Date May 17, 2019
Estimated Study Start Date  ICMJE June 1, 2019
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2019)
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quantification of Right Ventricular Function Using Simultaneous Transthoracic and Transoesophageal Echocardiography
Official Title  ICMJE Quantification of Right Ventricular Function Using Simultaneous Transthoracic and Transoesophageal Echocardiography
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Cardiac Surgery
Intervention  ICMJE 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.
Study Arms  ICMJE 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.

Intervention: Diagnostic Test: TTE and TOE
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 15, 2019) 		150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2020
Estimated Primary Completion Date June 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03954002
Other Study ID Numbers  ICMJE 2018/00987
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party National University Hospital, Singapore
Study Sponsor  ICMJE National University Hospital, Singapore
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chang Chuan Melvin Lee, MBBS, MMed National University Health System
PRS Account National University Hospital, Singapore
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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