Optimal Feeding Tube Placement

Not Applicable

Completed

• Conditions: Enteral Feeding Intolerance
• Interventions: Device: CORTRAK enteral access system; Device: Enteric Tube

• Registration Number: NCT04241146
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-01-06
• Primary Completion: 2018-10-10
• Study Completion: 2019-11-21
• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-01-23
• Results First Submitted: 2020-01-25
• Study First Posted: 2020-01-27
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-13
• Last Update Submitted: 2020-02-13
• Results First Posted: 2020-02-25
• Last Update Posted: 2020-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CORTRAK enteral access system (CEAS) placement	CORTRAK enteral access system	An electromagnetic device used to enable enteral nutrition tube placement
Standard Blind Technique of Tube placement	Enteric Tube	FDA approved technique of enteral nutrition tube placement

Primary Outcome Measures

Name	Time	Method
Duration of Time	Baseline to End of procedure up to 30 minutes	Time taken for placement of enteral tube

Secondary Outcome Measures

Name	Time	Method
Number of X-Rays	Baseline to End of procedure up to 30 minutes	Number of X-rays required to achieve correct tube placement

Trial Locations

Locations (1)

University Hospital; 🇺🇸 San Antonio, Texas, United States