Confirming Feeding Tube Position Using CORTRAK

Confirming Feeding Tube Position Using the CORTRAK Enteral Access System

This study will compare the accuracy of the CORTRAK enteral access system (CEAS) to x-ray for the determination of feeding tube position within the abdomen.

Study Overview

• Status: Not yet recruiting
• Conditions: Enteral Nutrition
• Intervention / Treatment: Device: CORTRAK Stylet

Detailed Description

In the inpatient pediatric care area (PICU, PCCU, PIMU, ACU), when an x-ray is performed for any reason and a patient has a CORTRAK feeding tube, a provider from the research team will re-insert the small, individualized, flexible stylet back into the patient's feeding tube and document the position of the tube on the CORTRAK display monitor. The x-ray will be obtained by current standard of care and the tube location on x-ray will be compared to the tube location on the CORTRAK monitor. The x-ray will only be obtained as part of the routine care decided by the medical team, the patient will not receive any additional x-rays for this study.

• Study Type: Interventional
• Enrollment (Anticipated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Megan Foster, MD; Phone Number: 210-415-9215; Email: fosterm3@uthscsa.edu
• Study Contact Backup: Name: Andrew Meyer, MD; Phone Number: 210-567-4424; Email: meyera@uthscsa.edu

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University Health Systems Hospital
      • Contact: Megan Foster, MD; Phone Number: 210-415-9215; Email: fosterm3@uthscsa.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 17 years (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• CORTRAK feeding tube placed as part of clinical care
• Getting xray for any reason
• CORTRAK Stylet available in the room
• Pediatric patients (Aged 17 or younger)

Exclusion Criteria:

-CORTRAK Stylet has been misplaced

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Feeding Tube Placement using CORTRAK stylet; Subjects will already have a feeding tube placed and are undergoing X-rays for placement confirmation.	Device: CORTRAK Stylet; The stylet is a component of the CORTRAK feeding tube system used to confirm the correct placement of the feeding tube; Other Names: Feeding tube stylet
No Intervention: Feeding Tube Placement using X-Ray; Routine X-ray is used to confirm feeding tube placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmation of correct placement of the Feeding tube	An x-ray will be obtained first as per standard of care and within 4 hours of the x-ray, the research procedure will occur. Following slow and careful removal of the stylet, the research team member will ensure there has been no movement of the feeding tube per the depth indicators on the outside of the tube. The location of the tube as it appears on the CORTRAK monitor will be documented and the location of the tube on x-ray will be documented. This will be reported as number of times that the tube is correctly placed.	Baseline to removal of feeding tube (on average 10-14 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Radiographs required for placement	Count of radiographs used to ensure correct placement of enteral feeding tube	Baseline to removal of feeding tube (on average 10-14 days)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2024
• Primary Completion (Anticipated): June 1, 2025
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: October 19, 2020
• First Submitted That Met QC Criteria: October 19, 2020
• First Posted (Actual): October 23, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HSC20200625H

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