N/A
N=25
Transesophageal Echocardiography (TEE) to Guide and Confirm Epidural Catheters in Pediatric Patients
Epidural Space
Bottom Line
View on ClinicalTrials.gov: NCT02415998 ↗Enrolled (actual)
25
Serious AEs
0.0%
Results posted
May 2020
Primary outcome: Primary: Number of Participants With Successful Epidural Catheter Placement — 17; 3 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- TEE (Procedure)
- Age
- Pediatric, Adult
- Sex
- All
- Sponsor
- Kenichi Ueda
- Primary completion
- Sep 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Epidural Catheter Placement |
17; 3 | — |
Summary
The aim of this study is to assess whether transesophageal echocardiography (TEE) can be used to successfully guide an epidural catheter to a targeted thoracic level in pediatric patients. The catheter will be placed in the epidural space under real-time TEE imaging and assistance by a trained TEE operator (this could include an anesthesiologist or cardiologist).
Eligibility Criteria
Inclusion Criteria
- pediatric patients scheduled to undergo cardiothoracic surgery or interventional cardiology diagnostic procedures under general anesthesia. All subjects will also be scheduled to undergo post-operative chest x-ray as a routine part of their clinical care, so no additional exposure to ionizing radiation will occur due to this study.
Exclusion Criteria
- patients with known esophageal abnormalities, lesions or disease that would disqualify the patient for the use of TEE as standard procedure. We will further exclude any patients that are solely undergoing TEE diagnostic procedures and only include patients that are already scheduled to undergo procedures where TEE is used as part of routine surgical preparation.
Data sourced from ClinicalTrials.gov (NCT02415998). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.