Confirming Feeding Tube Position Using CORTRAK

Study Overview
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Brief Summary
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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
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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.

Official Title
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Confirming Feeding Tube Position Using the CORTRAK Enteral Access System

Conditions
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Enteral Nutrition

Intervention / Treatment
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* Device: CORTRAK Stylet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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) |