Trial Outcomes & Findings for Transesophageal Echocardiography (TEE) to Guide and Confirm Epidural Catheters in Pediatric Patients (NCT NCT02415998)
NCT ID: NCT02415998
Last Updated: 2020-05-28
Results Overview
The success rate achieved using TEE guidance to thread an epidural catheter to within one targeted thoracic spinal level. Post-operative radiograph will be used to confirm catheter position.
Recruitment status
COMPLETED
Target enrollment
25 participants
Primary outcome timeframe
within one day
Results posted on
2020-05-28
Participant Flow
Participant milestones
| Measure |
TEE Guided Epidural Catheter Placement
TEE: Epidural catheter will be placed under guidance of transesophageal echography in specific thoracic spinal segment.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TEE Guided Epidural Cather Placement
n=25 Participants
TEE: Epidural catheter will be placed under guidance of transesophageal echography in specific thoracic spinal segment.
|
|---|---|
|
Age, Categorical
<=18 years
|
25 Participants
n=25 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=25 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=25 Participants
|
PRIMARY outcome
Timeframe: within one dayThe success rate achieved using TEE guidance to thread an epidural catheter to within one targeted thoracic spinal level. Post-operative radiograph will be used to confirm catheter position.
Outcome measures
| Measure |
TEE Guided Epidural Catheter Placement
n=20 Participants
TEE: Epidural catheter will be placed under guidance of transesophageal echography in specific thoracic spinal segment.
|
|---|---|
|
Number of Participants With Successful Epidural Catheter Placement
Successful placement
|
17 Participants
|
|
Number of Participants With Successful Epidural Catheter Placement
Unsuccessful placement
|
3 Participants
|
Adverse Events
TEE Guided Epidural Cather Placement
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