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

NCT05415449 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2025-11-19

Study results available
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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.

Conditions

  • Central Line

Interventions

DEVICE

Gus gear protective wearable device

Gus gear protective wearable device for central line.

Sponsors & Collaborators

  • Gus Gear Inc

    collaborator UNKNOWN

  • Society of Pediatric Nurses

    collaborator UNKNOWN

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Maria Leal, BSN, RN, CPN · Children's Health UTSW

Eligibility

Min Age
0 Years
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-14
Primary Completion
2025-05-28
Completion
2025-05-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05415449 on ClinicalTrials.gov