Status:
COMPLETED
Exploration of Central Venous Catheter Protective Devices in the Pediatric Population: A Mixed Methods Study
Lead Sponsor:
University of Texas Southwestern Medical Center
Collaborating Sponsors:
Gus Gear Inc
Society of Pediatric Nurses
Conditions:
Central Line
Eligibility:
All Genders
Up to 12 years
Brief Summary
1. to determine the feasibility of utilizing a wearable device 2. to prospectively measure and evaluate parent and nurse satisfaction with the protective wearable device. This is a sequential, conver...
Eligibility Criteria
Inclusion
- Patients with CVCs ages 0 to 12 years of age
- May currently utilizing or historically utilized the interventional wearable protective device
- Caregiver or parent available
- English and Spanish speaking subjects
Exclusion
- • Females with Tanner 2 breast or greater breast development. Justification: the wearable device will not fit properly to secure the CVC and may increase the risk of complications. If the patient does develop breast during the time of the study, then the patient will no longer wear the wrap and will go back to securing their device in the traditional way. Tanner 2 breast development will be evaluated in the screening process of patients.
- Patients in critical care services such as neonates, trauma/ neurology intensive care unit, or cardiac intensive care unit. Justification: These patients are not mobile with their CVC and not the targeted population.
Key Trial Info
Start Date :
December 14 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 28 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05415449
Start Date
December 14 2022
End Date
May 28 2025
Last Update
November 19 2025
Active Locations (1)
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1
Children's Health
Dallas, Texas, United States, 75235