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

Central Line Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05415449
• Other study ID #: STU-2022-0306
• Status: Recruiting
• Start date: December 14, 2022
• Est. completion date: August 2024

Study information

• Verified date: October 2023
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Central Line

Intervention

Device:
• Gus gear protective wearable device
Gus gear protective wearable device for central line.

Locations

Country	Name	City	State
United States	Children's Health	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	Gus Gear Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility measurement from Parents of Children using the Gus gear vest device	Interview parents (of children using Gus gear vest) on device.	Two weeks from recruitment, plus or minus seven days.
Primary	Satisfaction survey from Parents of Children using the Gus gear vest device	Every month complete 30-day satisfaction survey for a total of three data collection period	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.
Primary	Satisfaction survey from nurses	Satisfaction survey from nurses of Children using the Gus gear vest device	Anytime during the study period up to nine months.