Innovative Central Line Securement Device in the Pediatric Population

Study Overview
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Brief Summary
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This study involves evaluating pediatric patients with central lines to determine differences in line complications and quality of life in those with a novel central line securement device (wrap) as compared to those who use a traditional securement device (dressing).

Detailed Description
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Children with central lines experience line breaks, line dislodgment's and line infections as a result of traditional securement techniques (dressings). These issues lead to the patients' increased health care utilization and possibly to restriction of movement and delayed development as the children are restricted in their home environment. The purpose of this study is to determine if a wearable central line securement device, can decrease the number of line breaks, line dislodgment and line infections as compared to traditional securement techniques. The hypothesis is that the use of this wearable central line securement device can reduce line breaks, line dislodgment and line infections as compared to the traditional adhesive dressing. A secondary outcome for evaluation will be quality of life. Children are naturally active, however their activity is restricted by the parents given the delicate nature of their line. This study looks to see if quality of life can be improved a more secure wearable attachment device, as compared to traditional securement techniques.

Official Title
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Innovative Central Line Securement Device: Line Complications and Quality of Life in the Pediatric Population as Compared to Traditional Securement Device

Conditions
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Quality of Life, Pediatric Disorder, Central Line Complication, Central Line Infection, Central Line-Associated Infection, Central Line Sepsis, Short Gut Syndrome

Intervention / Treatment
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* Device: Wearable Central Line Securement Device (Vest)
* Other: Traditional Securement Dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a central line ages 0-18 years old who have never worn a wearable central line securement device (vest) will be eligible for the study. Exclusion Criteria: Those children who currently wear a central line securement device (vest) Children with central lines who are 19 years or older Those females with central lines and Tanner 2 breast or greater breast development as a wearable central line securement device (vest) will not fit properly to secure the central line and may increase the risk of the central line 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. The investgators will still collect data on that patient and they will be evaluated in the device arm consistent with the intention to treat principle.

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients with central lines ages 0-18 years old who have never worn a wearable central line securement device (vest) will be eligible for the study. Half of the participants will be randomized to the device arm while the other half of participants will be randomized to the non-device arm. They will be block randomized based on age upon enrollment. Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear. The study will follow participants prospectively for approximately one year (2020 - 2021).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Device<br>Those in the device arm will be given two wearable central line securement devices and the investigators will encourage continuous wear throughout the duration of the study. | Device: Wearable Central Line Securement Device (Vest)<br>* The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.<br>|
| Active Comparator: Traditional Securement Dressing<br>Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care. | Other: Traditional Securement Dressing<br>* This is a adhesive patch that is traditionally used to secure the external portion of a central line.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Outcome - Line Breaks | Number of line breaks | For a maximum of 1 year from enrollment | 
| Primary Outcome - Line Dislodgment | Number of line dislodgments | For a maximum of 1 year from enrollment | 
| Primary Outcome - Line Infections | Number of and line infections | For a maximum of 1 year from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in parental stress at 3 months | Changes to the mean of parental stress measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs.3months | 
| Change from baseline in parental stress at 6 months | Changes to the mean of parental stress measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 6 months | 
| Change from baseline in parental stress at 9 months | Changes to the mean of parental stress measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 9 months | 
| Change from baseline in parental stress at 12 months | Changes to the mean of parental stress measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 12 months | 
| Change from baseline in child activity level at 3 months | Changes to the mean of child activity level measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 3 months | 
| Change from baseline in child activity level at 6 months | Changes to the mean of child activity level measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 6 months | 
| Change from baseline in child activity level at 9 months | Changes to the mean of child activity level measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs.9 months | 
| Change from baseline in child activity level at 12 months | Changes to the mean of child activity level measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs.12 months | 
| Change from baseline in sleep at 3 months | Changes to the mean of sleep measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 3 months | 
| Change from baseline in sleep at 6 months | Changes to the mean of sleep measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 6 months | 
| Change from baseline in sleep at 9 months | Changes to the mean of sleep measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 9 months | 
| Change from baseline in sleep at 12 months | Changes to the mean of sleep measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 12 months | 
| Change from baseline in school at 3 months | Changes to the mean of school measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 3 months | 
| Change from baseline in school at 6 months | Changes to the mean of school measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 6 months | 
| Change from baseline in school at 9 months | Changes to the mean of school measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 9 months | 
| Change from baseline in school at 12 months | Changes to the mean of school measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 12 months | 
| Change from baseline in extracurricular activities at 3 months | Changes to the mean of extracurricular activities measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 3 months | 
| Change from baseline in extracurricular activities at 6 months | Changes to the mean of extracurricular activities measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs.6 months | 
| Change from baseline in extracurricular activities at 9 months | Changes to the mean of extracurricular activities measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 9 months | 
| Change from baseline in extracurricular activities at 12 months | Changes to the mean of extracurricular activities measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 12 months | 
| Change from baseline in family travel at 3 months | Changes to the mean of family travel measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 3 months | 
| Change from baseline in family travel at 6 months | Changes to the mean of family travel measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 6 months | 
| Change from baseline in family travel at 9 months | Changes to the mean of family travel measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 9 months | 
| Change from baseline in family travel at 12 months | Changes to the mean of family travel measured by a 4 category Likert Scale through a modified Baxter Scale Quality of Life (QOL) questionnaire. | Baseline vs. 12 months |