Confirming Feeding Tube Position Using CORTRAK

Enteral Nutrition Clinical Trial

Official title:

Confirming Feeding Tube Position Using the CORTRAK Enteral Access System

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04601571
• Other study ID #: HSC20200625H
• Status: Withdrawn
• Phase: N/A
• Start date: March 2024
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Enteral Nutrition

Intervention

Device:
• CORTRAK Stylet
The stylet is a component of the CORTRAK feeding tube system used to confirm the correct placement of the feeding tube

Locations

Country	Name	City	State
United States	University Health Systems Hospital	San Antonio	Texas

Sponsors (1)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)