Enteral Nutrition
Conditions
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.
Interventions
DEVICECORTRAK Stylet
The stylet is a component of the CORTRAK feeding tube system used to confirm the correct placement of the feeding tube
Sponsors
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
A non-inferior cohort study design
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed