Transesophageal Echocardiography (TEE): A Novel Technique for Spinal Cord Imaging

January 17, 2020 updated by: Kenichi Ueda
The aim of this prospective observational study is to assess whether transesophageal echocardiography (TEE) can be used to identify the structures within the vertebral foramen of the spinal column and to determine the range of spinal segments which can be visualized.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this prospective observational study is to assess whether transesophageal echocardiography (TEE) can be used to identify the structures within the vertebral foramen of the spinal column and to determine the range of spinal segments which can be visualized. Data will be collected from both pediatric and adult patients undergoing cardiothoracic and interventional cardiac surgeries under general anesthesia. Because use of TEE is a standard surgical procedure and because TEE will already be in place to visualize the heart, no additional processes will be required to collect data, minimizing patient risk. TEE will be monitored and controlled by a trained anesthesiologist or TEE technician and visualization of the spinal cord will be confirmed. Real-time TEE images will then be captured and later graded by a trained sonographer as high, medium or low quality. Starting at the level of the tracheal bifurcation, corresponding to thoracic vertebral level T5 (Mirajalili 2012), the TEE probe will be advanced cranially to determine the spinal levels visualized above T5 and caudally in order to determine the spinal levels below T5 that can be seen on TEE. At each level seen on TEE, pictures will be taken for confirmation.

Study Type

Observational

Enrollment (Actual)

75

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

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hosptials and Clinics

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All age population going under cardiac surgery

Description

Inclusion Criteria:

  • patients scheduled for cardiothoracic or interventional cardiac surgeries under general anesthesia

Exclusion Criteria:

  • We will exclude any patients with known esophageal abnormalities, lesions or disease that would disqualify the patient for the use of TEE as standard procedure.
  • We will also exclude any patients that come to the catheter laboratory exclusively for TEE exam as our study will only occur in patients already scheduled to undergo TEE use in surgery or diagnostic procedure.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Age 0 - 18
TEE visualization of the spinal cords in patients age between 0 - 18
Procedure: TEE
Spinal cord segments will be imaged using the TEE
Age 18 plus
TEE visualization of the spinal cords in patients age 18 or greater
Procedure: TEE
Spinal cord segments will be imaged using the TEE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Thoracic Spinal Segments Successfully Visualized With TEE
Time Frame: within 30 minutes
Count the number of short axis views of thoracic spinal cord segment and surrounding structure visualized with TEE in pediatric and adults patients.
within 30 minutes

Collaborators and Investigators

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

Sponsor

Kenichi Ueda

Investigators

  • Principal Investigator: Kenichi Ueda, MD, University of Iowa

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

July 1, 2012

Primary Completion (Actual)

September 23, 2017

Study Completion (Actual)

September 23, 2017

Study Registration Dates

First Submitted

April 8, 2015

First Submitted That Met QC Criteria

April 13, 2015

First Posted (Estimate)

April 14, 2015

Study Record Updates

Last Update Posted (Actual)

January 22, 2020

Last Update Submitted That Met QC Criteria

January 17, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 201206753

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.

Clinical Trials on Epidural

Clinical Trials on TEE

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe