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CompletedNCT03264183TEEUpdated Jun 24, 2019

Validating TEE Measurements of Right Ventricular Function

An observational study in Ventricular Function, Right and Echocardiography, Transesophageal, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-06-24.

Sponsored by Milton S. Hershey Medical Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
126
Ages
18 Years and older
Sex
All
01

Study summary

Transesophageal echocardiography (TEE) is becoming a more prevalent method of monitoring and diagnosis in the perioperative setting for critically ill patients and patients undergoing cardiac surgery. Many TEE measurements are extrapolated from transthoracic echocardiography (TTE) data and have not validated by transesophageal means. The aim of this study is to validate TEE assessment of right ventricular function by comparing them to simultaneously measured TTE measurements.

Likewise, there are currently no agreed upon values for RV free wall strain. Therefore, the investigators will attempt to define a range of normal values of RV free wall strain as compared to the other measures of RV function.

Read the detailed description

Traditionally, all echocardiographic measurements have been studied utilizing TTE. Therefore the normal values and ranges for pathology findings have been defined by transthoracic means alone. TEE offers different images planes when compared to TTE, which may make the measurements obtained differ from those obtained by TTE. In the operating room environment the vast majority of echocardiography is completed by transesophageal means for many reasons; largely access to the patient and the continuous use of TEE as a hemodynamic monitor. However, given the fact that most echocardiographic measurements have only been validated by TTE, there remains a question as to the validity or precision of TEE-derived measurements.

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Conditions studied

  • Ventricular Function, Right
  • Echocardiography, Transesophageal
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In context

Lead sponsor

Milton S. Hershey Medical Center is the lead sponsor of 491 studies on the registry; 59 are open to participants now.

Of its 58 completed or terminated interventional studies of FDA-regulated products, 45 (78%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All patients undergoing elective cardiac surgery, which as a standard of care, requires transesophageal echocardiography.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients undergoing elective cardiac surgery requiring TEE

Exclusion criteria

Exclusion Criteria:

  • Patient who do not wish to consent
  • Patients with contraindications to TEE
  • Urgent or emergent cardiac surgery
  • Patients with preexisting open chest
  • Patients with intrathoracic hardware (VAD, thoracostomy tube, etc)
  • Non-English speaking subjects
  • Cognitively impaired adults
  • Pregnancy
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
126 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testTransesophageal Echocardiography

    TEE measures of right ventricular function

    Also known as: TEE

  • Diagnostic testTransthoracic Echocardiography

    TTE measures of right ventricular function

    Also known as: TTE

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What researchers measure

Primary outcomes

  1. Right ventricular index of myocardial performance (RIMP)

    Right ventricular index of myocardial performance (RIMP) will be measured using both TTE and TEE.

    Time frame: Immediately following the induction of anesthesia and TEE probe placement

  2. Tricuspid annular plane systolic excursion (TAPSE)

    Tricuspid annular plane systolic excursion (TAPSE) will be measured using both TTE and TEE.

    Time frame: Immediately following the induction of anesthesia and TEE probe placement

  3. Right ventricular fractional area change (FAC)

    Right ventricular fractional area change (FAC) will be measured using both TTE and TEE.

    Time frame: Immediately following the induction of anesthesia and TEE probe placement

  4. RV annular systolic velocity (S')

    RV annular systolic velocity (S') will be measured using both TTE and TEE.

    Time frame: Immediately following the induction of anesthesia and TEE probe placement

  5. RV free wall longitudinal strain

    RV free wall longitudinal strain will be measured using both TTE and TEE.

    Time frame: Immediately following the induction of anesthesia and TEE probe placement

Secondary outcomes

  1. Ease of obtaining appropriate TEE measures of right ventricular function

    Ease of acquisition will be assessed by the echocardiographers

    Time frame: Within 15 minutes following anesthesia induction

  2. Define values for normal right ventricular free wall strain

    The data collected will be used to define normal values for right ventricular free wall strain

    Time frame: Through study completion, an estimate of 1 year

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Study locations

1 site
  • Milton S. Hershey Medical Center
    Hershey, Pennsylvania 17033, United States
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References and documents

Publications

  • Barakat AF, Sperry BW, Starling RC, Mentias A, Popovic ZB, Griffin BP, Desai MY. Prognostic Utility of Right Ventricular Free Wall Strain in Low Risk Patients After Orthotopic Heart Transplantation. Am J Cardiol. 2017 Jun 1;119(11):1890-1896. doi: 10.1016/j.amjcard.2017.03.003. Epub 2017 Mar 15. PubMed 28390683 ↗
  • Bellavia D, Iacovoni A, Scardulla C, Moja L, Pilato M, Kushwaha SS, Senni M, Clemenza F, Agnese V, Falletta C, Romano G, Maalouf J, Dandel M. Prediction of right ventricular failure after ventricular assist device implant: systematic review and meta-analysis of observational studies. Eur J Heart Fail. 2017 Jul;19(7):926-946. doi: 10.1002/ejhf.733. Epub 2017 Mar 31. PubMed 28371221 ↗
  • Howard-Quijano K, Salem A, Barkulis C, Mazor E, Scovotti JC, Ho JK, Shemin RJ, Grogan T, Elashoff D, Mahajan A. Preoperative Three-Dimensional Strain Imaging Identifies Reduction in Left Ventricular Function and Predicts Outcomes After Cardiac Surgery. Anesth Analg. 2017 Feb;124(2):419-428. doi: 10.1213/ANE.0000000000001440. PubMed 27782943 ↗
  • Kemal HS, Kayikcioglu M, Kultursay H, Vuran O, Nalbantgil S, Mogulkoc N, Can L. Right ventricular free-wall longitudinal speckle tracking strain in patients with pulmonary arterial hypertension under specific treatment. Echocardiography. 2017 Apr;34(4):530-536. doi: 10.1111/echo.13472. Epub 2017 Mar 23. PubMed 28332221 ↗
  • Peyrou J, Chauvel C, Pathak A, Simon M, Dehant P, Abergel E. Preoperative right ventricular dysfunction is a strong predictor of 3 years survival after cardiac surgery. Clin Res Cardiol. 2017 Sep;106(9):734-742. doi: 10.1007/s00392-017-1117-y. Epub 2017 Apr 13. PubMed 28409231 ↗
  • Sokalskis V, Peluso D, Jagodzinski A, Sinning C. Added clinical value of applying myocardial deformation imaging to assess right ventricular function. Echocardiography. 2017 Jun;34(6):919-927. doi: 10.1111/echo.13521. Epub 2017 Mar 19. PubMed 28317170 ↗
  • Tousignant C, Desmet M, Bowry R, Harrington AM, Cruz JD, Mazer CD. Speckle tracking for the intraoperative assessment of right ventricular function: a feasibility study. J Cardiothorac Vasc Anesth. 2010 Apr;24(2):275-9. doi: 10.1053/j.jvca.2009.10.022. Epub 2010 Jan 6. PubMed 20056440 ↗
  • Agac MT, Akyuz AR, Acar Z, Akdemir R, Korkmaz L, Kiris A, Erkus E, Erkan H, Celik S. Evaluation of right ventricular function in early period following transcatheter closure of atrial septal defect. Echocardiography. 2012 Mar;29(3):358-62. doi: 10.1111/j.1540-8175.2011.01558.x. Epub 2011 Nov 8. PubMed 22066780 ↗
  • Akiyama K, Arisawa S, Ide M, Iwaya M, Naito Y. Intraoperative cardiac assessment with transesophageal echocardiography for decision-making in cardiac anesthesia. Gen Thorac Cardiovasc Surg. 2013 Jun;61(6):320-9. doi: 10.1007/s11748-013-0208-6. Epub 2013 Feb 13. PubMed 23404310 ↗
  • Carerj S, Micari A, Trono A, Giordano G, Cerrito M, Zito C, Luzza F, Coglitore S, Arrigo F, Oreto G. Anatomical M-mode: an old-new technique. Echocardiography. 2003 May;20(4):357-61. doi: 10.1046/j.1540-8175.2003.03041.x. PubMed 12848879 ↗
  • Chan J, Wahi S, Cain P, Marwick TH. Anatomical M-mode: A novel technique for the quantitative evaluation of regional wall motion analysis during dobutamine echocardiography. Int J Card Imaging. 2000 Aug;16(4):247-55. doi: 10.1023/a:1026539708034. PubMed 11219596 ↗
  • David JS, Tousignant CP, Bowry R. Tricuspid annular velocity in patients undergoing cardiac operation using transesophageal echocardiography. J Am Soc Echocardiogr. 2006 Mar;19(3):329-34. doi: 10.1016/j.echo.2005.09.013. PubMed 16500497 ↗
  • Hahn RT, Abraham T, Adams MS, Bruce CJ, Glas KE, Lang RM, Reeves ST, Shanewise JS, Siu SC, Stewart W, Picard MH. Guidelines for performing a comprehensive transesophageal echocardiographic examination: recommendations from the American Society of Echocardiography and the Society of Cardiovascular Anesthesiologists. J Am Soc Echocardiogr. 2013 Sep;26(9):921-64. doi: 10.1016/j.echo.2013.07.009. No abstract available. PubMed 23998692 ↗
  • Ito S, Pislaru SV, Soo WM, Huang R, Greason KL, Mathew V, Sandhu GS, Eleid MF, Suri RM, Oh JK, Nkomo VT. Impact of right ventricular size and function on survival following transcatheter aortic valve replacement. Int J Cardiol. 2016 Oct 15;221:269-74. doi: 10.1016/j.ijcard.2016.07.085. Epub 2016 Jul 6. PubMed 27404688 ↗
  • Magunia H, Schmid E, Hilberath JN, Haberle L, Grasshoff C, Schlensak C, Rosenberger P, Nowak-Machen M. 2D Echocardiographic Evaluation of Right Ventricular Function Correlates With 3D Volumetric Models in Cardiac Surgery Patients. J Cardiothorac Vasc Anesth. 2017 Apr;31(2):595-601. doi: 10.1053/j.jvca.2016.11.020. Epub 2016 Nov 14. PubMed 28129939 ↗
  • Markin NW, Chamsi-Pasha M, Luo J, Thomas WR, Brakke TR, Porter TR, Shillcutt SK. Transesophageal Speckle-Tracking Echocardiography Improves Right Ventricular Systolic Function Assessment in the Perioperative Setting. J Am Soc Echocardiogr. 2017 Feb;30(2):180-188. doi: 10.1016/j.echo.2016.10.002. Epub 2016 Dec 1. PubMed 27916237 ↗
  • Mishra M, Swaminathan M, Malhotra R, Mishra A, Trehan N. Evaluation of Right Ventricular Function During CABG: Transesophageal Echocardiographic Assessment of Hepatic Venous Flow Versus Conventional Right Ventricular Performance Indices. Echocardiography. 1998 Jan;15(1):51-58. doi: 10.1111/j.1540-8175.1998.tb00577.x. PubMed 11175010 ↗
  • Morita Y, Nomoto K, Fischer GW. Modified Tricuspid Annular Plane Systolic Excursion Using Transesophageal Echocardiography for Assessment of Right Ventricular Function. J Cardiothorac Vasc Anesth. 2016 Jan;30(1):122-6. doi: 10.1053/j.jvca.2015.07.024. Epub 2015 Jul 28. PubMed 26520027 ↗
  • Niimi Y, Hiki M, Ishiguro Y, Goto T, Morita S. Determination of right ventricular function by transesophageal echocardiography: impact of proximal right coronary artery stenosis. J Clin Anesth. 2004 Mar;16(2):104-10. doi: 10.1016/j.jclinane.2003.05.009. PubMed 15110371 ↗
  • Portnoy SG, Rudski LG. Echocardiographic evaluation of the right ventricle: a 2014 perspective. Curr Cardiol Rep. 2015;17(4):21. doi: 10.1007/s11886-015-0578-8. PubMed 25725606 ↗
  • Rafferty T, Durkin M, Harris S, Elefteriades J, Hines R, Prokop E, O'Connor T. Transesophageal two-dimensional echocardiographic analysis of right ventricular systolic performance indices during coronary artery bypass grafting. J Cardiothorac Vasc Anesth. 1993 Apr;7(2):160-6. doi: 10.1016/1053-0770(93)90210-c. PubMed 8477020 ↗
  • Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available. PubMed 20620859 ↗
  • Shillcutt SK, Brakke TR, Thomas WR, Porter TR, Lisco SJ. The development of a perioperative echocardiography consult service: the Nebraska experience. J Cardiothorac Vasc Anesth. 2015;29(3):777-84. doi: 10.1053/j.jvca.2014.09.010. Epub 2015 Jan 6. No abstract available. PubMed 25575406 ↗
  • Shillcutt SK, Markin NW, Montzingo CR, Brakke TR. Use of rapid "rescue" perioperative echocardiography to improve outcomes after hemodynamic instability in noncardiac surgical patients. J Cardiothorac Vasc Anesth. 2012 Jun;26(3):362-70. doi: 10.1053/j.jvca.2011.09.029. Epub 2012 Jan 4. PubMed 22226417 ↗
  • Strotmann JM, Kvitting JP, Wilkenshoff UM, Wranne B, Hatle L, Sutherland GR. Anatomic M-mode echocardiography: A new approach to assess regional myocardial function--A comparative in vivo and in vitro study of both fundamental and second harmonic imaging modes. J Am Soc Echocardiogr. 1999 May;12(5):300-7. doi: 10.1016/s0894-7317(99)70050-7. PubMed 10231615 ↗
  • Tousignant C, Bowry R, Cruz JD, Mazer CD. Induction of anesthesia does not alter tricuspid annular velocities: a tissue Doppler assessment. Can J Anaesth. 2009 Oct;56(10):757-62. doi: 10.1007/s12630-009-9157-z. Epub 2009 Jul 29. PubMed 19639373 ↗
  • 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. PubMed 22302303 ↗
  • Williams B, Sikorski R, Anders M, Galvagno S, Rock P, Mazzeffi M. Should We Use Perioperative Transesophageal Echocardiography More in Non-Cardiac Surgery? J Cardiothorac Vasc Anesth. 2018 Jun;32(3):e71-e73. doi: 10.1053/j.jvca.2016.03.153. Epub 2016 Mar 31. No abstract available. PubMed 27474334 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03264183
Responsible party
Shayne Michael Roberts (Assistant Professor, Milton S. Hershey Medical Center) — Principal investigator
First posted
Aug 29, 2017
Start date
Sep 18, 2017
Primary completion
Oct 10, 2018
Completion
Oct 10, 2018
Last update
Jun 24, 2019

Study contacts

Shayne M Roberts, DO
principal investigator · Milton S. Hershey Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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