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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01968252
Other study ID # 0107-14-EP
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2014
Est. completion date November 1, 2015

Study information

Verified date August 2023
Source University of Nebraska
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The study is designed to validate the use of speckle-tracking echocardiography to measure tricuspid annular plane systolic excursion as a measurement of right ventricular function during transesophageal echocardiography.


Description:

1. Use of speckle-tracking echocardiography to validate tricuspid annular plane systolic excursion measurements with transesophageal echocardiography. 2. This study intends to validate the use of speckle-tracking echocardiography to measure the distance the tricuspid annulus moves during the systolic phase. The guideline articles regarding right ventricular function suggest m-mode measurements from the transthoracic approach and the same measurements may underestimate the actual distance on transesophageal echocardiography. This speckle-tracking technology will allow this distance to be measured despite its often non-parallel motion to the ultrasound beam, which otherwise limits the reliability of the valve recorded. 3. All subjects undergoing a planned surgical procedure in which the use of transesophageal echocardiography would be used regardless for their management. 4. No interventions, only evaluation of the measurements obtained with transthoracic echocardiography compared to transesophageal echocardiography. 5. No follow-up, study will be completed at the time of image acquisition.


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date November 1, 2015
Est. primary completion date February 1, 2015
Accepts healthy volunteers No
Gender All
Age group 19 Years to 90 Years
Eligibility Inclusion Criteria: - All subjects who are scheduled to undergo general anesthesia and concurrently will be managed with intraoperative transesophageal echocardiography will be included in potential subjects. Exclusion Criteria: - Subjects who do not have adequate transesophageal and/or transthoracic imaging windows to allow for accurate analysis of tricuspid annular motion.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Concurrent TTE and TEE
All subjects will undergo both transthoracic echocardiography and transesophageal echocardiography to compare the results of measurements obtained from both imaging locations.

Locations

Country Name City State
United States Unversity of Nebraska Medical Center Omaha Nebraska

Sponsors (1)

Lead Sponsor Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

References & Publications (4)

Ahmad H, Mor-Avi V, Lang RM, Nesser HJ, Weinert L, Tsang W, Steringer-Mascherbauer R, Niel J, Salgo IS, Sugeng L. Assessment of right ventricular function using echocardiographic speckle tracking of the tricuspid annular motion: comparison with cardiac magnetic resonance. Echocardiography. 2012;29(1):19-24. doi: 10.1111/j.1540-8175.2011.01519.x. Epub 2011 Oct 4. — View Citation

Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA, Picard MH, Roman MJ, Seward J, Shanewise JS, Solomon SD, Spencer KT, Sutton MS, Stewart WJ; Chamber Quantification Writing Group; American Society of Echocardiography's Guidelines and Standards Committee; European Association of Echocardiography. Recommendations for chamber quantification: a report from the American Society of Echocardiography's Guidelines and Standards Committee and the Chamber Quantification Writing Group, developed in conjunction with the European Association of Echocardiography, a branch of the European Society of Cardiology. J Am Soc Echocardiogr. 2005 Dec;18(12):1440-63. doi: 10.1016/j.echo.2005.10.005. No abstract available. — View Citation

Mor-Avi V, Lang RM, Badano LP, Belohlavek M, Cardim NM, Derumeaux G, Galderisi M, Marwick T, Nagueh SF, Sengupta PP, Sicari R, Smiseth OA, Smulevitz B, Takeuchi M, Thomas JD, Vannan M, Voigt JU, Zamorano JL. Current and evolving echocardiographic techniques for the quantitative evaluation of cardiac mechanics: ASE/EAE consensus statement on methodology and indications endorsed by the Japanese Society of Echocardiography. J Am Soc Echocardiogr. 2011 Mar;24(3):277-313. doi: 10.1016/j.echo.2011.01.015. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Speckle-tracking derived tricuspid annular plane systolic excursion with transesophageal echocardiography Speckle-tracking derived tricuspid annular plane systolic excursion with transesophageal echocardiography 1 hour
Secondary M-mode derived tricuspid annular plane systolic excursion with transesophageal echocardiography M-mode derived tricuspid annular plane systolic excursion with transesophageal echocardiography 1 hour
Secondary M-mode derived tricuspid annular plane systolic excursion with transthoracic echocardiography M-mode derived tricuspid annular plane systolic excursion with transthoracic echocardiography 1 hour
Secondary Speckle-tracking derived tricuspid annular plane systolic excursion with transthoracic echocardiography Speckle-tracking derived tricuspid annular plane systolic excursion with transthoracic echocardiography 1 hour
See also
  Status Clinical Trial Phase
Completed NCT03264183 - Validating TEE Measurements of Right Ventricular Function