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Speckle-tracking Tricuspid Annular Plane Systolic Excursion

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ClinicalTrials.gov Identifier: NCT01968252
Recruitment Status : Completed
First Posted : October 23, 2013
Last Update Posted : December 2, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Ventricular Function, Right Other: Concurrent TTE and TEE

Detailed 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.

Study Design

Study Type : Observational
Actual Enrollment : 112 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Validation of Speckle-tracking Echocardiography Measurements of Tricuspid Annular Plane Systolic Excursion During Transesophageal Echocardiography
Study Start Date : May 2014
Primary Completion Date : February 2015
Study Completion Date : November 2015
Groups and Cohorts

Group/Cohort Intervention/treatment
Intraoperative Patient
All patients in the cohort will be scheduled to undergo a planned surgical procedure in which the subject will undergo general anesthesia and the procedure and/or the patient will require transesophageal echocardiographic monitoring for the procedure.
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.


Outcome Measures

Primary Outcome Measures :
  1. Speckle-tracking derived tricuspid annular plane systolic excursion with transesophageal echocardiography [ Time Frame: 1 hour ]

Secondary Outcome Measures :
  1. M-mode derived tricuspid annular plane systolic excursion with transesophageal echocardiography [ Time Frame: 1 hour ]
  2. M-mode derived tricuspid annular plane systolic excursion with transthoracic echocardiography [ Time Frame: 1 hour ]
  3. Speckle-tracking derived tricuspid annular plane systolic excursion with transthoracic echocardiography [ Time Frame: 1 hour ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All subjects will be scheduled to undergo a surgical procedure requiring general anesthesia and either due to subject factors or procedure factors, the use of intraoperative transesophageal echocardiographic monitoring will occur. These subjects will then have both transesophageal and transthoracic echocardiographic measurements of one variable of right ventricular function to validate the results from the transesophageal window.
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01968252


Locations
United States, Nebraska
The Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Sponsors and Collaborators
University of Nebraska
More Information

Publications:

Responsible Party: Nicholas Markin, Assistant Professor, University of Nebraska
ClinicalTrials.gov Identifier: NCT01968252     History of Changes
Other Study ID Numbers: 107-14-EP
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: November 2015

Keywords provided by Nicholas Markin, University of Nebraska:
Speckle-tracking echocardiography
Transthoracic echocardiography
Transesophageal echocardiography