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Despite the study being in active enrollment since 2020, the research staff has not been available to enroll patients because of lack of trained nursing staff.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feeding Tube Placement using CORTRAK stylet | Active Comparator | Subjects will already have a feeding tube placed and are undergoing X-rays for placement confirmation. |
|
| Feeding Tube Placement using X-Ray | No Intervention | Routine X-ray is used to confirm feeding tube placement |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CORTRAK Stylet | Device | The stylet is a component of the CORTRAK feeding tube system used to confirm the correct placement of the feeding tube |
|
| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
-CORTRAK Stylet has been misplaced
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Meyer, MD | University of Texas Health at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Systems Hospital | San Antonio | Texas | 78229 | United States |
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A non-inferior cohort study design
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