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Completed

NCT Number: NCT02415998

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

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).

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Key information

Conditions

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Iowa Hosptials and Clinics

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TEE

Procedure

Epidural catheter will be placed under guidance of transesophageal echography in specific thoracic spinal segment.

Primary outcomes

  1. Number of Participants With Successful Epidural Catheter Placement

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Kenichi Ueda

Other

Registry information

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Apr 14, 2015
Registry last updated
May 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.