Spinal Cord, Epidural
Conditions
Keywords
ultrasound
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.
Interventions
PROCEDURETEE
Spinal cord segments will be imaged using the TEE
Sponsors
Kenichi Ueda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Age 0 - 18 TEE visualization of the spinal cords in patients age between 0 - 3
TEE: Spinal cord segments will be imaged using the TEE | 50 |
| Age 18 Plus TEE visualization of the spinal cords in patients age 18 or greater
TEE: Spinal cord segments will be imaged using the TEE | 25 |
| Total | 75 |
Baseline characteristics
| Characteristic | Age 0 - 18 | Age 18 Plus | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 50 Participants | 0 Participants | 50 Participants |
| Age, Categorical >=65 years | 0 Participants | 6 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 19 Participants | 19 Participants |
| Age, Continuous | 5.0 years STANDARD_DEVIATION 4.8 | 52 years STANDARD_DEVIATION 20 | 20 years STANDARD_DEVIATION 25 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 23 Participants | 9 Participants | 32 Participants |
| Sex: Female, Male Male | 27 Participants | 16 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 25 |
| other Total, other adverse events | 0 / 50 | 0 / 25 |
| serious Total, serious adverse events | 0 / 50 | 0 / 25 |
Outcome results
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.
Time frame: within 30 minutes
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pediatric Group | Number of Thoracic Spinal Segments Successfully Visualized With TEE | 12 Thoracic segments |
| Adult Group | Number of Thoracic Spinal Segments Successfully Visualized With TEE | 10 Thoracic segments |