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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-14

Study Completion Date

2025-05-28

Brief Summary

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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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Detailed Description

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Conditions

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Central Line

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Gus gear protective wearable device

Intervention Type DEVICE

Gus gear protective wearable device for central line.

Interventions

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Gus gear protective wearable device

Gus gear protective wearable device for central line.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

0 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No