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

Epidural Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02415244
• Other study ID #: 201206753
• Status: Completed
• Start date: July 2012
• Est. completion date: September 23, 2017

Study information

• Verified date: January 2020
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: September 23, 2017
• Est. primary completion date: September 23, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Epidural
• Spinal Cord

Intervention

Procedure:
• TEE
Spinal cord segments will be imaged using the TEE

Locations

Country	Name	City	State
United States	University of Iowa Hosptials and Clinics	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Kenichi Ueda

Country where clinical trial is conducted

United States, 

References & Publications (4)

Chitilian HV, Alston TA, Avery EG. Transesophageal echocardiographic bull's eye. J Cardiothorac Vasc Anesth. 2006 Dec;20(6):894-5. Epub 2006 Feb 7. — View Citation

Daniel WG, Erbel R, Kasper W, Visser CA, Engberding R, Sutherland GR, Grube E, Hanrath P, Maisch B, Dennig K, et al. Safety of transesophageal echocardiography. A multicenter survey of 10,419 examinations. Circulation. 1991 Mar;83(3):817-21. — View Citation

Godet G, Couture P, Ionanidis G, Gosgnach M, Kieffer E, Viars P. Another application of two-dimensional transesophageal echocardiography: spinal cord imaging. A preliminary report. J Cardiothorac Vasc Anesth. 1994 Feb;8(1):14-8. — View Citation

Pissarra F, Oliveira A, Marcelino P. Transoesophageal echocardiography for monitoring liver surgery: data from a pilot study. Cardiol Res Pract. 2012;2012:723418. doi: 10.1155/2012/723418. Epub 2012 Apr 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Thoracic Spinal Segments Successfully Visualized With TEE	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