Epidural Space
Conditions
Keywords
TEE
Brief 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).
Detailed description
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. The primary outcome is to determine the success rate achieved using TEE guidance to thread an epidural catheter to a targeted thoracic spinal level. Post-operative radiograph will be used to confirm catheter position. The secondary outcomes include analysis of catheter tip position within the epidural space as anterior, lateral or inferior to the spinal cord. Further, efficacy of the catheter will be determined using the following criteria from previous studies: Hemodynamic response at skin incision analyzed by heart rate and systemic blood pressure changes using the no change in HR or BP or changes \< 20% from baseline were considered sufficient block to surgical stimulation, while HR or BP changes \> 20% from baseline were considered not sufficient block to surgical stimulation.
Interventions
PROCEDURETEE
Epidural catheter will be placed under guidance of transesophageal echography in specific thoracic spinal segment.
Sponsors
Kenichi Ueda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Epidural Catheter Placement | within one day | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TEE Guided Epidural Cather Placement TEE: Epidural catheter will be placed under guidance of transesophageal echography in specific thoracic spinal segment. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | TEE Guided Epidural Cather Placement | — |
|---|---|---|
| Age, Categorical <=18 years | 25 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 18 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Number of Participants With Successful Epidural Catheter Placement
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.
Time frame: within one day
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TEE Guided Epidural Catheter Placement | Number of Participants With Successful Epidural Catheter Placement | Successful placement | 17 Participants |
| TEE Guided Epidural Catheter Placement | Number of Participants With Successful Epidural Catheter Placement | Unsuccessful placement | 3 Participants |