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OpenTrials
Completed

NCT Number: NCT04241146

Optimal Feeding Tube Placement

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

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Key information

Conditions

Enteral Feeding Intolerance

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Enteric Tube

Device

A post pyloric feeding tube used in patients requiring enteral nutrition

Other names: Enteral nutrition tube

CORTRAK enteral access system

Device

Electromagnetic guidance system for enteric feeding tube placement

Other names: CEAS

Primary outcomes

  1. Duration of Time

    Time frame: Baseline to End of procedure up to 30 minutes

    Time taken for placement of enteral tube

Secondary outcomes

  1. Number of X-Rays

    Time frame: Baseline to End of procedure up to 30 minutes

    Number of X-rays required to achieve correct tube placement

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • Avanos Medical

Registry information

Official study title

A Randomized Controlled Trial for Optimal Feeding Tube Placement

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jan 27, 2020
Registry last updated
Feb 25, 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.

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