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Confirming Feeding Tube Position Using CORTRAK

Sponsor
The University of Texas Health Science Center at San Antonio (Other)
Overall Status
Recruiting
CT.gov ID
NCT04601571
Collaborator
(none)
75
Enrollment
1
Location
2
Arms
28.2
Anticipated Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CORTRAK Stylet
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A non-inferior cohort study designA non-inferior cohort study design
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Confirming Feeding Tube Position Using the CORTRAK Enteral Access System
Actual Study Start Date :
Jan 25, 2021
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
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

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 17 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Health Systems Hospital San Antonio Texas United States 78229

    Sponsors and Collaborators

    • The University of Texas Health Science Center at San Antonio

    Investigators

    • Principal Investigator: Andrew Meyer, MD, University of Texas Health at San Antonio

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Andrew D. Meyer, Associate Professor Pediatric Critical Care, The University of Texas Health Science Center at San Antonio
    ClinicalTrials.gov Identifier:
    NCT04601571
    Other Study ID Numbers:
    • HSC20200625H
    First Posted:
    Oct 23, 2020
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes

    Study Results

    No Results Posted as of Feb 8, 2022