NCT02415998

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 25 (actual)
• Sponsor: Kenichi Ueda · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epidural Space

Interventions

Type	Name	Description
PROCEDURE	TEE	Epidural catheter will be placed under guidance of transesophageal echography in specific thoracic spinal segment.

Timeline

• Start date: 2012-07-01
• Primary completion: 2017-09-23
• Completion: 2017-09-23
• First posted: 2015-04-14
• Last updated: 2020-05-28
• Results posted: 2020-05-28

Locations

1 site across 1 country: United States