Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Age 0 - 18 | TEE visualization of the spinal cords in patients age between 0 - 18 |
| |
| Age 18 plus | TEE visualization of the spinal cords in patients age 18 or greater |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TEE | Procedure | Spinal cord segments will be imaged using the TEE |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
All age population going under cardiac surgery
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kenichi Ueda, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hosptials and Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22611514 | Background | 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. | |
| 17138103 | Background | Chitilian HV, Alston TA, Avery EG. Transesophageal echocardiographic bull's eye. J Cardiothorac Vasc Anesth. 2006 Dec;20(6):894-5. doi: 10.1053/j.jvca.2005.09.007. Epub 2006 Feb 7. No abstract available. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Age 0 - 18 | TEE visualization of the spinal cords in patients age between 0 - 18 TEE: Spinal cord segments will be imaged using the TEE |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | Thoracic segments | within 30 minutes |
|
within 24 hours
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pediatric Group | Pediatric subjects | 0 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenichi Ueda | University of Iowa Hosptials and Clinics | 3193562633 | kenichi-ueda@uiowa.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2019 | Oct 22, 2019 | Prot_SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
| 1999032 | Background | 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. doi: 10.1161/01.cir.83.3.817. |
| 8167278 | Background | 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. doi: 10.1016/1053-0770(94)90005-1. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 50 |
| 0 |
| 50 |
| 0 |
| 50 |
| EG001 | Adult Group | Adult subjects | 0 | 25 | 0 | 25 | 0 | 25 |
Not provided
Not provided
Not provided