Confirming Feeding Tube Position Using CORTRAK

Not Applicable

Withdrawn

• Conditions: Enteral Nutrition
• Interventions: Device: CORTRAK Stylet

• Registration Number: NCT04601571
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief 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.

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 Timeline

• Study First Submitted: 2020-10-19
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-23
• Study Start: 2024-03
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-08
• Primary Completion: 2025-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Feeding Tube Placement using CORTRAK stylet	CORTRAK Stylet	Subjects will already have a feeding tube placed and are undergoing X-rays for placement confirmation.

Primary Outcome Measures

Name	Time	Method
Confirmation of correct placement of the Feeding tube	Baseline to removal of feeding tube (on average 10-14 days)	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University Health Systems Hospital; 🇺🇸 San Antonio, Texas, United States