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

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.

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Key information

Conditions

Central Line

Age range

0 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Health

Dallas, Texas, 75235, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gus gear protective wearable device

Device

Gus gear protective wearable device for central line.

Primary outcomes

Feasibility Measurement From Parents of Children Using the Gus Gear Vest Device

Time frame: Two weeks from recruitment, plus or minus seven days.

No. of participants who were interviewed i.e. parents (of children using Gus gear vest) on device. Semi-structured interview guide was used to collect interview from parents. Eligible parents were parents of children between 0-12 years of age using the vest, and Parents should be able to speak English/Spanish. Interviews being qualitative in nature, the criteria to assess feasibility from parents using the vest will be done using transcription and inductive content analysis to find codes and themes from the data provided by the parents during the interview.
Satisfaction Survey From Parents of Children Using the Gus Gear Vest Device

Time frame: 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

Time frame: Anytime during the study period up to nine months.

Satisfaction survey from nurses of Children using the Gus gear vest device

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

Gus Gear Inc
Society of Pediatric Nurses

Registry information

Important dates

Study start: 2022
Primary completion: 2025
Study completion: 2025
First posted: Jun 13, 2022
Registry last updated: Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed