Transesophageal Echocardiography (TEE) to Guide and Confirm Epidural Catheters in Pediatric Patients

Completed

• Conditions: Epidural Space
• Interventions: Procedure: TEE

• Registration Number: NCT02415998
• Lead Sponsor: Kenichi Ueda

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2015-04-06
• Study First Submitted QC: 2015-04-08
• Study First Posted: 2015-04-14
• Primary Completion: 2017-09-23
• Study Completion: 2017-09-23
• Results First Submitted: 2020-01-31
• Status Verified: 2020-05
• Results First Submitted QC: 2020-05-20
• Last Update Submitted: 2020-05-20
• Results First Posted: 2020-05-28
• Last Update Posted: 2020-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TEE	TEE	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Iowa Hosptials and Clinics; 🇺🇸 Iowa City, Iowa, United States