Clinical trial NCT02415998: Transesophageal Echocardiography (TEE) to Guide and Confirm Epidural Catheters in Pediatric Patients
Official title: Transesophageal Echocardiography (TEE) to Guide and Confirm Epidural Catheters in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epidural Space
Keywords: TEE
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2015-04-14
Enrollment: 25
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric population going under cardiac surgery

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.

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.

Primary outcomes:
measure: Number of Participants With Successful Epidural Catheter Placement
timeFrame: within one day
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hosptials and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Kenichi Ueda, MD
role: PRINCIPAL_INVESTIGATOR
References:
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