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

NCT05415449 | Completed Results FDA Device

• 1 other identifier: STU-2022-0306
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.to determine the feasibility of utilizing a wearable device
2. 2.to prospectively measure and evaluate parent and nurse satisfaction with the protective wearable device.

Conditions

Central Line

Outcome Measures

Primary Outcomes (3)

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

  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.

  Two weeks from recruitment, plus or minus seven days.

• 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.

• 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.

Study Arms (1)

No groups

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.

Device: Gus gear protective wearable device

Interventions

Gus gear protective wearable device DEVICE

Gus gear protective wearable device for central line.

No groups

Eligibility Criteria

• Age: 0 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with CVCs ages 0 to 12 years of age

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Gus Gear Inc: collaborator
• Society of Pediatric Nurses: collaborator

Study Sites (1)

Children's Health

Dallas, Texas, 75235, United States

Location

Results Point of Contact

• Title: Maria Leal
• Organization: Children's Medical Center

Maria.leal@childrens.com

2144560276

Study Officials

• Maria Leal, BSN, RN, CPN

  Children's Health UTSW

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Acute Care Services

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 13, 2022
• Study Start: December 14, 2022
• Primary Completion: May 28, 2025
• Study Completion: May 28, 2025
• Last Updated: November 19, 2025
• Results First Posted: November 19, 2025

Record last verified: 2025-11

Locations

US (1)