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

Completed

• Conditions: Epidural; Spinal Cord
• Interventions: Procedure: TEE

• Registration Number: NCT02415244
• Lead Sponsor: Kenichi Ueda

Brief Summary

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.

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 Timeline

• Study Start: 2012-07
• Study First Submitted: 2015-04-08
• Study First Submitted QC: 2015-04-13
• Study First Posted: 2015-04-14
• Primary Completion: 2017-09-23
• Study Completion: 2017-09-23
• Results First Submitted: 2018-03-19
• Results First Submitted QC: 2019-09-30
• Results First Posted: 2019-10-23
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-17
• Last Update Posted: 2020-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Age 0 - 18	TEE	TEE visualization of the spinal cords in patients age between 0 - 18
Age 18 plus	TEE	TEE visualization of the spinal cords in patients age 18 or greater

Primary Outcome Measures

Name	Time	Method
Number of Thoracic Spinal Segments Successfully Visualized With TEE	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.

Trial Locations

Locations (1)

University of Iowa Hosptials and Clinics; 🇺🇸 Iowa City, Iowa, United States