Exploration of Central Venous Catheter Protective Devices in the Pediatric Population: A Mixed Methods Study

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Jun 8, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring the use of a special wearable device designed to protect central venous catheters (CVCs) in children. CVCs are long, thin tubes that are placed in large veins to give medicine or nutrients, and they need to be kept safe to prevent infections or other problems. The study aims to find out how well this device works and how satisfied parents and nurses are with it. Researchers will first conduct interviews with parents and then collect satisfaction surveys over three months to gather their feedback.

To participate in the trial, children aged 0 to 12 who have a CVC are eligible as long as they have a parent or caregiver available to help. The study is open to both English and Spanish speakers. If a child has developed certain physical changes that make it hard to use the device properly, they may need to stop using it. Participants can expect to receive education about the device, wear it while in the hospital, and provide feedback about their experience. Importantly, the device is registered with the FDA, ensuring it meets safety standards.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • • 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.