Clinical trial NCT05415449: Exploration of Central Venous Catheter Protective Devices in the Pediatric Population: A Mixed Methods Study
Official title: Exploration of Central Venous Catheter Protective Devices in the Pediatric Population: A Mixed Methods Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Central Line
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Gus Gear Inc
First posted: 2022-06-13
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with CVCs ages 0 to 12 years of age

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility measurement from Parents of Children using the Gus gear vest device
timeFrame: Two weeks from recruitment, plus or minus seven days.
measure: Satisfaction survey from Parents of Children using the Gus gear vest device
timeFrame: 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.
measure: Satisfaction survey from nurses
timeFrame: Anytime during the study period up to nine months.
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Children's Health
state: Texas
Study officials:
affiliation: Children's Health UTSW
name: Maria Leal, BSN, RN, CPN
role: PRINCIPAL_INVESTIGATOR
References: