Speckle-tracking Tricuspid Annular Plane Systolic Excursion

Completed

• Conditions: Ventricular Function, Right
• Interventions: Other: Concurrent TTE and TEE

• Registration Number: NCT01968252
• Lead Sponsor: University of Nebraska

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.

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 Timeline

• Study First Submitted: 2013-10-16
• Study First Submitted QC: 2013-10-18
• Study First Posted: 2013-10-23
• Study Start: 2014-05-01
• Primary Completion: 2015-02-01
• Study Completion: 2015-11-01
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-30
• Last Update Posted: 2023-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intraoperative Patient	Concurrent TTE and TEE	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.

Primary Outcome Measures

Name	Time	Method
Speckle-tracking derived tricuspid annular plane systolic excursion with transesophageal echocardiography	1 hour	Speckle-tracking derived tricuspid annular plane systolic excursion with transesophageal echocardiography

Secondary Outcome Measures

Name	Time	Method
M-mode derived tricuspid annular plane systolic excursion with transthoracic echocardiography	1 hour	M-mode derived tricuspid annular plane systolic excursion with transthoracic echocardiography
M-mode derived tricuspid annular plane systolic excursion with transesophageal echocardiography	1 hour	M-mode derived tricuspid annular plane systolic excursion with transesophageal echocardiography
Speckle-tracking derived tricuspid annular plane systolic excursion with transthoracic echocardiography	1 hour	Speckle-tracking derived tricuspid annular plane systolic excursion with transthoracic echocardiography

Trial Locations

Locations (1)

Unversity of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States