Trial record 4 of 237 for:    Open Studies | "Echocardiography"

Speckle-tracking Echocardiography to Determine Tricuspid Annular Plane Systolic Excursion During Transesophageal Echocardiography.

This study is not yet open for participant recruitment.
Verified October 2013 by University of Nebraska
Sponsor:
Information provided by (Responsible Party):
Nicholas Markin, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01968252
First received: October 16, 2013
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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 Intervention
Ventricular Function, Right
Other: Concurrent transthoracic and transesophageal echocardiography

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Validation of Speckle-tracking Echocardiography Measurements of Tricuspid Annular Plane Systolic Excursion During Transesophageal Echocardiography

Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Speckle-tracking derived tricuspid annular plane systolic excursion with transesophageal echocardiography [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • M-mode derived tricuspid annular plane systolic excursion with transesophageal echocardiography [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • M-mode derived tricuspid annular plane systolic excursion with transthoracic echocardiography [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Speckle-tracking derived tricuspid annular plane systolic excursion with transthoracic echocardiography [ Time Frame: 1 hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2013
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 transthoracic and transesophageal echocardiography
All subjects will undergo both transthoracic echocardiography and transesophageal echocardiography to compare the results of measurements obtained from both imaging locations.

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.
  Eligibility

Ages Eligible for Study:   19 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01968252

Contacts
Contact: Nicholas W Markin, M.D. (402) 559-7122 nmarkin@unmc.edu

Locations
United States, Nebraska
The Nebraska Medical Center Not yet recruiting
Omaha, Nebraska, United States, 68198
Principal Investigator: Nicholas W Markin, M.D.         
Sponsors and Collaborators
University of Nebraska
  More Information

Publications:

Responsible Party: Nicholas Markin, Physician, University of Nebraska
ClinicalTrials.gov Identifier: NCT01968252     History of Changes
Other Study ID Numbers: 13-ER
Study First Received: October 16, 2013
Last Updated: October 18, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014