Spinal CordNCT02415244
Transesophageal Echocardiography (TEE): A Novel Technique for Spinal Cord Imaging
An observational study of Spinal Cord and Epidural, run by Kenichi Ueda at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Cord, Epidural
- What is being tested?
- TEE
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to 23 Sep 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All age population going under cardiac surgery
Who may be able to join
- patients scheduled for cardiothoracic or interventional cardiac surgeries under general anesthesia
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hosptials and Clinics
Iowa City, Iowa, 52242
About this study
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.
Read the 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.
- Conditions
- Spinal Cord, Epidural
- Being tested
- TEE
- Keywords
- ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEEProcedure or surgery
Spinal cord segments will be imaged using the TEE
| Study group | Role | What they receive |
|---|---|---|
| Age 0 - 18 | TEE visualization of the spinal cords in patients age between 0 - 18 Receives: Procedure: TEE | |
| Age 18 plus | TEE visualization of the spinal cords in patients age 18 or greater Receives: Procedure: TEE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: within 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2015 (estimated)
- Study startJul 2012
- Primary completion23 Sep 2017
- Study completion23 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Spinal CordStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kenichi Ueda
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kenichi Ueda, University of Iowa
- Investigators
- Kenichi Ueda, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02415244
- Sponsor's protocol ID
- 201206753
- Status last verified
- Jan 2020
- First submitted
- 8 Apr 2015
- Last updated
- 22 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22611514Chitilian 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.
PubMed 17138103Daniel 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.
PubMed 1999032Godet 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.
PubMed 8167278
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transesophageal Echocardiography (TEE): A Novel Technique for Spinal Cord Imaging
- ClinicalTrials.gov ID
- NCT02415244
- Acronym / sponsor ID
- 201206753
- Conditions
- Spinal Cord, Epidural
- Keywords
- ultrasound
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Kenichi UedaUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- 23 Sep 2017 (actual)
- Study completion
- 23 Sep 2017 (actual)
- First posted
- 14 Apr 2015 (estimated)
- Results
- Posted 23 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Age 0 - 18 | – | Procedure: TEETEE visualization of the spinal cords in patients age between 0 - 18 |
| Age 18 plus | – | Procedure: TEETEE visualization of the spinal cords in patients age 18 or greater |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All age population going under cardiac surgery
Key inclusion criteria (1 listed)
- patients scheduled for cardiothoracic or interventional cardiac surgeries under general anesthesia
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TEESpinal cord segments will be imaged using the TEE | Procedure or surgery | Age 0 - 18, Age 18 plus |
Primary outcome
Number of Thoracic Spinal Segments Successfully Visualized With TEE
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22611514Pissarra 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.
- Background: PubMed 17138103Chitilian 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.
- Background: PubMed 1999032Daniel 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.
- Background: PubMed 8167278Godet 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenichi Ueda, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord and Epidural, run by Kenichi Ueda at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Thoracic Spinal Segments Successfully Visualized With TEE (time frame: within 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02415244, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2020.