NCT04601571

Confirming Feeding Tube Position Using CORTRAK

Confirming Feeding Tube Position Using the CORTRAK Enteral Access System

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Enteral Nutrition

Interventions

Type	Name	Description
DEVICE	CORTRAK Stylet	The stylet is a component of the CORTRAK feeding tube system used to confirm the correct placement of the feeding tube

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2020-10-23
• Last updated: 2024-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study