Optimal Feeding Tube Placement

A Randomized Controlled Trial for 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.

Study Overview

• Status: Completed
• Conditions: Enteral Feeding Intolerance
• Intervention / Treatment: Device: Enteric Tube; Device: CORTRAK enteral access system

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Standard Blind Technique of Tube placement; FDA approved technique of enteral nutrition tube placement	Device: Enteric Tube; A post pyloric feeding tube used in patients requiring enteral nutrition; Other Names: Enteral nutrition tube
ACTIVE_COMPARATOR: CORTRAK enteral access system (CEAS) placement; An electromagnetic device used to enable enteral nutrition tube placement	Device: CORTRAK enteral access system; Electromagnetic guidance system for enteric feeding tube placement; Other Names: CEAS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Time	Time taken for placement of enteral tube	Baseline to End of procedure up to 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of X-Rays	Number of X-rays required to achieve correct tube placement	Baseline to End of procedure up to 30 minutes

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: Avanos Medical
• Investigators: Principal Investigator: Andrew Meyer, MD, University of Texas Health San Antonio

Publications and helpful links

General Publications

• Jha P, Rupp L, Bonilla L, Gelfond J, Shah JN, Meyer AD. Electromagnetic Versus Blind Guidance of a Postpyloric Feeding Tube in Critically Ill Children. Pediatrics. 2020 Oct;146(4):e20193773. doi: 10.1542/peds.2019-3773.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 6, 2018
• Primary Completion (ACTUAL): October 10, 2018
• Study Completion (ACTUAL): November 21, 2019

Study Registration Dates

• First Submitted: January 21, 2020
• First Submitted That Met QC Criteria: January 23, 2020
• First Posted (ACTUAL): January 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 25, 2020
• Last Update Submitted That Met QC Criteria: February 13, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: pediatrics; enteral nutrition; nursing care; radiation exposure; radiation, non-ionizing
• Other Study ID Numbers: HSC20170704H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified data is available to all researchers upon contact of sponsoring organization and investigator Andrew D. Meyer.
• IPD Sharing Time Frame: Data will be available after primary manuscript is accepted for publication.
• IPD Sharing Access Criteria: Data will be available in journal publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No