NCT05415449

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 30 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 0 Years – 12 Years
• Healthy volunteers: Not accepted

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, convergent mixed methods study design in which qualitative interview data will be collected first followed by quantitative data. Scheme and Outcomes: Identify eligible patients--Informed Consent--Provide education and two protective wearable device--Demographic data (electronic health record)--Interview parent on device--Every month complete 30-day satisfaction survey for a total of three data collection period-Discharge from study. Nurse data collection scheme: Study participants hospitalized at time of enrollment in study or anytime during the study period. Nurse of patients using device will complete satisfaction survey. Note: Vest is a Class I Exempt FDA-registered device.

Conditions

• Central Line

Interventions

Type	Name	Description
DEVICE	Gus gear protective wearable device	Gus gear protective wearable device for central line.

Timeline

• Start date: 2022-12-14
• Primary completion: 2025-05-28
• Completion: 2025-05-28
• First posted: 2022-06-13
• Last updated: 2025-11-19
• Results posted: 2025-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study