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

Recruiting

• Conditions: Central Line
• Interventions: Device: Gus gear protective wearable device

• Registration Number: NCT05415449
• Lead Sponsor: University of Texas Southwestern Medical Center

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, 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-31
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-13
• Study Start: 2022-12-14
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-04
• Last Update Posted: 2024-11-06
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No groups	Gus gear protective wearable device	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.

Primary Outcome Measures

Name	Time	Method
Feasibility measurement from Parents of Children using the Gus gear vest device	Two weeks from recruitment, plus or minus seven days.	Interview parents (of children using Gus gear vest) on device.
Satisfaction survey from Parents of Children using the Gus gear vest device	Every month for a total of three data collection periods up to 3 months. Team will have plus or minus seven-day timeframe around the 30-day window to collect the data.	Every month complete 30-day satisfaction survey for a total of three data collection period
Satisfaction survey from nurses	Anytime during the study period up to nine months.	Satisfaction survey from nurses of Children using the Gus gear vest device

Trial Locations

Locations (1)

Children's Health; 🇺🇸 Dallas, Texas, United States