Speckle-tracking Tricuspid Annular Plane Systolic Excursion

August 30, 2023 updated by: University of Nebraska

Validation of Speckle-tracking Echocardiography Measurements of Tricuspid Annular Plane Systolic Excursion During Transesophageal Echocardiography

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.

Study Overview

Status

Completed

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

112

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Unversity of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 90 years (Adult, Older Adult)

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Speckle-tracking derived tricuspid annular plane systolic excursion with transesophageal echocardiography
Time Frame: 1 hour
Speckle-tracking derived tricuspid annular plane systolic excursion with transesophageal echocardiography
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
M-mode derived tricuspid annular plane systolic excursion with transesophageal echocardiography
Time Frame: 1 hour
M-mode derived tricuspid annular plane systolic excursion with transesophageal echocardiography
1 hour
M-mode derived tricuspid annular plane systolic excursion with transthoracic echocardiography
Time Frame: 1 hour
M-mode derived tricuspid annular plane systolic excursion with transthoracic echocardiography
1 hour
Speckle-tracking derived tricuspid annular plane systolic excursion with transthoracic echocardiography
Time Frame: 1 hour
Speckle-tracking derived tricuspid annular plane systolic excursion with transthoracic echocardiography
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nicholas W Markin, MD, University of Nebraska

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

October 16, 2013

First Submitted That Met QC Criteria

October 18, 2013

First Posted (Estimated)

October 23, 2013

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 30, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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