Optimal Feeding Tube Placement

The University of Texas System (UT)

Status: Completed

Conditions: Enteral Feeding Intolerance

Treatments: Device: CORTRAK enteral access system; Device: Enteric Tube

Study type: Interventional

Funder types: Other

Identifiers

NCT04241146

HSC20170704H

Details and patient eligibility

About

A randomized controlled trial comparing current standard blind method to CORTRAK enteral access system (CEAS), an FDA approved electromagnetic device to place enteric tubes.

Full description

Patient population would include patients in pediatric intensive care unit, pediatric cardiac unit, intermediate medical care unit and pediatric floor who receives postpyloric feeding tube placements. The study team are going to monitor total time and number attempts required for each successful placement, correlation of findings on x-ray versus CEAS, cost-effectiveness of this new equipment with standard blind method and decrease in radiation exposure with CEAS.

Enrollment: 52 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Patient admitted to pediatric floor, intermediate care unit, pediatric intensive care unit, or congenital care unit requiring post-pyloric feeding tube placement of size eight french or more and not meeting any of exclusion criteria

Exclusion Criteria: Under three kilograms, Open chest wall, Open abdominal wall

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Standard Blind Technique of Tube placement

Active Comparator group

Description:

FDA approved technique of enteral nutrition tube placement

Treatment:

Device: Enteric Tube

CORTRAK enteral access system (CEAS) placement

Active Comparator group

Description:

An electromagnetic device used to enable enteral nutrition tube placement

Treatment:

Device: CORTRAK enteral access system