Efficacy of Ben-Guard Garment in Reducing Pediatric Central Line Complications

Study Overview
=================
Brief Summary
-----------------
Central venous catheter (CVC) insertion is a common surgical procedure performed in children for the delivery of nutritional support, medications, frequent blood draws or transfusions. Maintaining hygienic conditions is absolutely necessary in order to avoid contamination of the catheter and tubing to avoid bloodstream infections. Fractures in the tubing is a common complication that places children at increased risk for infections. In order to help keep the tubing stable to avoid fractures and dislodgements, a wearable device was created called Ben-Guard. This pilot study is being undertaken to determine if the Ben-Guard device will reduce the incidence and severity of adverse events in children requiring CVCs.

Detailed Description
-----------------
Conduct a pragmatic pilot study of the Ben-Guard Catheter Safety Device in 40 pediatric patients with central venous catheters (CVC). Participants will be issued 3-5 garments, which are expected to be worn at all times. This study will be conducted over an 18 month period. Participants are expected to wear the garment daily for the duration of the study (or duration of their treatment if <18 months). Data will be reviewed every 3 months to measure the garment's acceptability and effect on the frequency of central line-associated complications. Outcomes will be compared to a matched retrospective cohort. This study will use the device consistent with the description as a registered FDA Class 1 device. The investigators are conducting this study to clinically and scientifically evaluate the device's ability to change the frequency of CVC fractures and CVC complications in children.

Official Title
-----------------
Efficacy of Ben-Guard Garment in Reducing the Frequency of Pediatric Central Line Complications: A Pilot Study

Conditions
-----------------
Central Venous Catheters

Intervention / Treatment
-----------------
* Device: Ben-Guard Garment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants age 0-10 medical disease or condition that requires a CVC for treatment, supportive care or nutritional support English Speaking Exclusion Criteria: Any patient who received a non-tunneled CVC Any patient who had a tunneled CVC placed from an outside institution Age > 10 Patients that cannot communicate or read English

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 10 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ben-Guard user<br>Participants will wear the garment for up to 18 months while needing a central line catheter. | Device: Ben-Guard Garment<br>* Wearable device designed to secure CVCs and gastrointestinal feeding tubes. The Ben-Guard Catheter Securement Device was designed specifically to better secure and conceal CVC tubing, protecting the patient by keeping tubing closer to the body.<br>|
| No Intervention: Retrospective match control<br>Matched historical control for intervention group based on age, gender and duration of use of a central venous catheter. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of CVC Fractures | compared to retrospective cohort | Up to 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of CVC Dislodgements | The frequency of CVC dislodgements compared to a matched retrospective cohort. | Up to 18 months | 
| Total Number of Central-Line Associated Blood Stream Infections (CLABSIs) | Number of central-line associated blood stream infections compared to a matched retrospective cohort. | Up to 18 months | 
| Total Number of CVC-related Emergency Department or Urgent Care Visits | The number of CVC-related emergency department visits compared to a matched retrospective cohort. | Up to 18 months | 
| Mean CVC-related Total Healthcare Associated Costs | Mean CVC-related total healthcare-associated costs compared to a matched retrospective cohort. | Up to 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Central venous catheter, complication