N/A
N=30
Exploration of Central Venous Catheter Protective Devices in the Pediatric Population: A Mixed Methods Study
Central Line
Bottom Line
View on ClinicalTrials.gov: NCT05415449 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcome: Primary: Feasibility Measurement From Parents of Children Using the Gus Gear Vest Device — 12 Interviews
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Gus gear protective wearable device (Device)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Texas Southwestern Medical Center
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility Measurement From Parents of Children Using the Gus Gear Vest Device |
12 | — |
| PRIMARY Satisfaction Survey From Parents of Children Using the Gus Gear Vest Device |
— | — |
| PRIMARY Satisfaction Survey From Nurses |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05415449). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.