Central Line
Conditions
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.
Interventions
DEVICEGus gear protective wearable device
Gus gear protective wearable device for central line.
Sponsors
Gus Gear Inc
Society of Pediatric Nurses
University of Texas Southwestern Medical Center
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Years to 12 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility Measurement From Parents of Children Using the Gus Gear Vest Device | 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 | 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 | Anytime during the study period up to nine months. | Satisfaction survey from nurses of Children using the Gus gear vest device |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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: Gus gear protective wearable device for central line. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | No Groups | — |
|---|---|---|
| Age, Categorical <=18 years | 30 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 24 Participants | — |
| Sex: Female, Male Female | 14 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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.
Time frame: Two weeks from recruitment, plus or minus seven days.
Population: 30 is the enrolled number for quantitative piece of the study. Being mixed methods in nature in design, this study also has qualitative part. Upon interviewing 12 parents, thematic saturation was achieved to conclude data collection for the qualitative part of the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| No Groups | Feasibility Measurement From Parents of Children Using the Gus Gear Vest Device | 12 Interviews |
Primary
Satisfaction Survey From Nurses
Satisfaction survey from nurses of Children using the Gus gear vest device
Time frame: Anytime during the study period up to nine months.
Primary
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
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.