Purpose

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.

Condition

Eligibility

Eligible Ages
Under 17 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
A non-inferior cohort study design
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

More Details

Status
Not yet recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Megan Foster, MD
210-415-9215
fosterm3@uthscsa.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.