NCT02415244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

April 8, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2017

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

October 23, 2019

Completed
Last Updated

January 22, 2020

Status Verified

January 1, 2020

Enrollment Period

5.2 years

First QC Date

April 8, 2015

Results QC Date

March 19, 2018

Last Update Submit

January 17, 2020

Conditions

Keywords

ultrasound

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Age 0 - 18

TEE visualization of the spinal cords in patients age between 0 - 18

Procedure: TEE

Age 18 plus

TEE visualization of the spinal cords in patients age 18 or greater

Procedure: TEE

Interventions

TEEPROCEDURE

Spinal cord segments will be imaged using the TEE

Age 0 - 18Age 18 plus

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All age population going under cardiac surgery

You may qualify if:

  • patients scheduled for cardiothoracic or interventional cardiac surgeries under general anesthesia

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa Hosptials and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (4)

  • 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.

    PMID: 22611514BACKGROUND
  • 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.

    PMID: 17138103BACKGROUND
  • 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.

    PMID: 1999032BACKGROUND
  • 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.

    PMID: 8167278BACKGROUND

Results Point of Contact

Title
Kenichi Ueda
Organization
University of Iowa Hosptials and Clinics

Study Officials

  • Kenichi Ueda, MD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

April 8, 2015

First Posted

April 14, 2015

Study Start

July 1, 2012

Primary Completion

September 23, 2017

Study Completion

September 23, 2017

Last Updated

January 22, 2020

Results First Posted

October 23, 2019

Record last verified: 2020-01

Locations