Trial Outcomes & Findings for Transesophageal Echocardiography (TEE): A Novel Technique for Spinal Cord Imaging (NCT NCT02415244)
NCT ID: NCT02415244
Last Updated: 2020-01-22
Results Overview
Count the number of short axis views of thoracic spinal cord segment and surrounding structure visualized with TEE in pediatric and adults patients.
Recruitment status
COMPLETED
Target enrollment
75 participants
Primary outcome timeframe
within 30 minutes
Results posted on
2020-01-22
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
25
|
|
Overall Study
COMPLETED
|
50
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Age 0 - 18
n=50 Participants
TEE visualization of the spinal cords in patients age between 0 - 3
TEE: Spinal cord segments will be imaged using the TEE
|
Age 18 Plus
n=25 Participants
TEE visualization of the spinal cords in patients age 18 or greater
TEE: Spinal cord segments will be imaged using the TEE
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
50 Participants
n=50 Participants
|
0 Participants
n=25 Participants
|
50 Participants
n=75 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=50 Participants
|
19 Participants
n=25 Participants
|
19 Participants
n=75 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=50 Participants
|
6 Participants
n=25 Participants
|
6 Participants
n=75 Participants
|
|
Age, Continuous
|
5.0 years
STANDARD_DEVIATION 4.8 • n=50 Participants
|
52 years
STANDARD_DEVIATION 20 • n=25 Participants
|
20 years
STANDARD_DEVIATION 25 • n=75 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=50 Participants
|
9 Participants
n=25 Participants
|
32 Participants
n=75 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=50 Participants
|
16 Participants
n=25 Participants
|
43 Participants
n=75 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: within 30 minutesCount the number of short axis views of thoracic spinal cord segment and surrounding structure visualized with TEE in pediatric and adults patients.
Outcome measures
| Measure |
Pediatric Group
n=50 Participants
Visible thoracic epidural segments were counted in pediatric patients with TEE
|
Adult Group
n=25 Participants
Visible thoracic epidural segments were counted with TEE
|
|---|---|---|
|
Number of Thoracic Spinal Segments Successfully Visualized With TEE
|
12 Thoracic segments
Interval 12.0 to 12.0
|
10 Thoracic segments
Interval 6.0 to 12.0
|
Adverse Events
Pediatric Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Adult Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place