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

• Sponsor: Kenichi Ueda (Other)
• Overall Status: Completed
• CT.gov ID: NCT02415244
• Collaborator: (none)
• Enrollment: 75
• Location: 1
• Duration (Months): 62.8
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord; Epidural	Procedure: TEE

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 Design

• Study Type: Observational
• Actual Enrollment: 75 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Transesophageal Echocardiography (TEE): A Novel Technique for Spinal Cord Imaging
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Sep 23, 2017
• Actual Study Completion Date: Sep 23, 2017

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Iowa Hosptials and Clinics	Iowa City	Iowa	United States	52242

Sponsors and Collaborators

• Kenichi Ueda

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 1, 2019

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: Kenichi Ueda, Clinical Associate Professor, University of Iowa
• ClinicalTrials.gov Identifier: NCT02415244
• Other Study ID Numbers: 201206753
• First Posted: Apr 14, 2015
• Last Update Posted: Jan 22, 2020
• Last Verified: Jan 1, 2020

• Keywords provided by Kenichi Ueda, Clinical Associate Professor, University of Iowa: ultrasound

Study Results

Participant Flow

Arm/Group Title	Age 0 - 18	Age 18 Plus
Arm/Group Description	TEE visualization of the spinal cords in patients age between 0 - 18 TEE: Spinal cord segments will be imaged using the TEE	TEE visualization of the spinal cords in patients age 18 or greater TEE: Spinal cord segments will be imaged using the TEE
Period Title: Overall Study
STARTED	50	25
COMPLETED	50	25
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Age 0 - 18	Age 18 Plus	Total
Arm/Group Description	TEE visualization of the spinal cords in patients age between 0 - 3 TEE: Spinal cord segments will be imaged using the TEE	TEE visualization of the spinal cords in patients age 18 or greater TEE: Spinal cord segments will be imaged using the TEE	Total of all reporting groups
Overall Participants	50	25	75
Age (Count of Participants)
<=18 years	50 100%	0 0%	50 66.7%
Between 18 and 65 years	0 0%	19 76%	19 25.3%
>=65 years	0 0%	6 24%	6 8%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	5.0 (4.8)	52 (20)	20 (25)
Sex: Female, Male (Count of Participants)
Female	23 46%	9 36%	32 42.7%
Male	27 54%	16 64%	43 57.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Pediatric Group	Adult Group
Arm/Group Description	Visible thoracic epidural segments were counted in pediatric patients with TEE	Visible thoracic epidural segments were counted with TEE
Measure Participants	50	25
Median (Inter-Quartile Range) [Thoracic segments]	12	10

Adverse Events

Time Frame	within 24 hours
Arm/Group Title	Pediatric Group		Adult Group
Arm/Group Description	Pediatric subjects		Adult subjects
All Cause Mortality
	Pediatric Group		Adult Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/25 (0%)
Serious Adverse Events
	Pediatric Group		Adult Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Pediatric Group		Adult Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/50 (0%)		0/25 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.