Optimal Feeding Tube Placement

Enteral Feeding Intolerance Clinical Trial

Official title:

A Randomized Controlled Trial for Optimal Feeding Tube Placement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04241146
• Other study ID #: HSC20170704H
• Status: Completed
• Phase: N/A
• Start date: January 6, 2018
• Est. completion date: November 21, 2019

Study information

• Verified date: February 2020
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: November 21, 2019
• Est. primary completion date: October 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Enteral Feeding Intolerance

Intervention

Device:
• Enteric Tube
A post pyloric feeding tube used in patients requiring enteral nutrition
• CORTRAK enteral access system
Electromagnetic guidance system for enteric feeding tube placement

Locations

Country	Name	City	State
United States	University Hospital	San Antonio	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	Avanos Medical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of Time	Time taken for placement of enteral tube	Baseline to End of procedure up to 30 minutes
Secondary	Number of X-Rays	Number of X-rays required to achieve correct tube placement	Baseline to End of procedure up to 30 minutes