Innovative Central Line Securement Device: Line Complications and Quality of Life in the Pediatric Population as Compared to Traditional Securement Device
Phase: NA
Conditions: Central Line Complication, Central Line Infection, Central Line-Associated Infection, Central Line Sepsis, Short Gut Syndrome, Quality of Life, Pediatric Disorder
Sponsor: Ryan St. Pierre-Hetz

Study Protocol 
 
Title:  Innovative Central Line Securement Device: Line Complications and Quality of Life in 
the Pediatric Population as Compared to Traditional Securement Device   
 
STUDY19010059 
NCT04522778 
 
08/01/2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
Background 
Central venous access devices (CVADs) are used in a wide variety of conditions to deliver 
medications, hydration, and intravenous feeding. CVADs are used in multiple conditions 
including cancer, short gut syndrome, chronic intestinal pseudo-obstruction, Crohn's disease, 
ulcerative colitis, mitochondrial disease, cystic fibrosis, just to name a few. Tunneled central 
lines are thin catheters inserted under the skin and into a large vein for long-term use and are 
particularly fragile in several locations including the thinnest part of the line and near the hub. 
Line repair is reported in as many as 33% of catheters (1) and there is a 3-fold increase in sepsis 
in the 30 days following line repair (2). Line trauma is a common cause for repair, especially in 
the pediatric portion population due to children's lack of safety awareness, nearly constant 
movement, and poor impulse control (3). Currently, pediatric tunneled CVADs have a failure 
rate of 29% prior to completion of therapy (4). This leads to a significant burden on the 
healthcare system by necessitating additional time in the hospital to place a new line, lost time 
receiving treatment or nutrition, loss of access site (only six available vessels), and the potential 
for further complications including death (5,6). Preventing line trauma directly impacts long-
term outcomes by preserving central access, with clinicians seeking a safe, comfortable harness 
for CVAD securement to minimize line trauma and its resulting complications (7). 
 
Objectives 
This study will compare traditional central line securement methods to a novel central line 
securement device. Primary outcomes include rates of line breaks, line dislodgments and line 
infections. Secondary outcomes include changes to quality of life scores on a validated survey 
tool.  
 
Design and Methods 
Patients with central lines ages 0-18 years old (anyone <19 at time of recruitment) who have 
never worn Gus Gear will be eligible for the study. We will plan to recruit 200 patients. They 
will be block randomized based on age upon enrollment to either the securement device of 
traditional methods. Those in the device arm will be given Gus Gear devices and we will 
encourage continuous wear. The study will follow participants prospectively for approximately 
one year.  
 
Patients will be recruited from an intestinal failure care clinic during care visits. Investigators JY 
and KA will introduce the study during the check in process. If families are interested they will 
be consented by researchers RS and MM.  
   
Once consented patients were block randomized based on their age from between Birth < 12mo, 
between 12mo < 4 years and between 4 years < 18 years. Patients will be assigned to either 
receive a central line securement device or continue using the standard of care sterile dressing 
over their central line. If patients are randomized to receive the device, they will be fitted 
according to manufacturer protocols, which consists of a chest measurement.  
 
After randomization and device securement if applicable, all families will fill out a baseline 
demographics form and a baseline quality of life survey. Patients will then be followed for 12 
months from initial enrollment. At subsequent clinic visits patients and families will fill out 

follow-up surveys detailing potential line related complications. They were also be given the 
same quality of life survey that they filled out at the time of initial enrollment. These follow-up 
surveys will be administered between 3-4 times throughout the year. Subjects’ charts will be 
routinely reviewed over the study, monitoring for line related complications. 
 
 
Eligibility Criteria 
Patients eligible for inclusion were between the age of 0-18 with long term central line use for 
total parenteral nutrition in the setting of PIF.    
Patients who were excluded from the study were those older than the age of 18, any patient who 
had used a central line securement vest before and any adolescent female with greater than 
Tanner 2 breast development. All females enrolled were monitored routinely for breast 
development, as patients with great than Tanner 1 breasts do not fit properly into the vest for safe 
line securement.   
 
 
Statistical Consideration 
Statistical Package for Social Sciences (SPSS Version 28.0, Armonk, NY) will be used for 
descriptive analysis of primary outcome data. Event rates were averaged for both cohorts before 
enrollment and after enrollment. Subjects will be compared to themselves pre and post 
intervention. A paired T-Test will be used to evaluate for treatment effect after enrollment.   
 
Quality of life data will be recorded in RedCap using ordinal scales. Therefore, we will  compare 
responses to individual questions between the dressing group and securement device group using 
ordinal logistic regression, adjusting for clustering of responses within a participant.  We will 
present results as the ordinal odds ratio and 95% confidence intervals for a unit change in 
response level for each question.  (analysis in STATA 16.1, College Station, TX).  
 
 
 
 
 
 
 
 
 
 
 
 
1. Hwang FR1, Stavropoulos SW, Shlansky-Goldberg RD, Mondschein JI, Patel AA, Solomon 
JA, Itkin M, Soulen MC, Chittams JL, Trerotola SO. Tunneled infusion catheter breakage: 
frequency and repair kit outcomes. J Vasc Interv Radiol. 2008 Feb;19(2 Pt 1):201-6. doi: 
10.1016/j.jvir.2007.08.030. 
 
2. Lundgren IS, Zhou C, Malone FR, McAfee NG, Gantt S, Zerr D. Central Venous Catheter 
Repair is Associated with an Increased Risk of Bacteremia and Central Line Associated 

Bloodstream Infection in Pediatric Patients. Pediatr Infect Dis J. 2012 Apr; 31(4): 337–340. 
 
3. Cesaro S, Corrò R, Pelosin A, et al. A prospective survey on incidence and outcome of 
Broviac/Hickman catheter-related complications in pediatric patients affected by hematological 
and oncological diseases. Ann Hematol. 2004;83(3):183–188pmid:15064868. 
 
4. Ullman AJ, Marsh N, Mihala G, Cooke M, Rickard CM. Complications of Central Venous 
Access Devices: A Systematic Review. Pediatrics. 2015 Nov;136(5):e1331-44. doi: 
10.1542/peds.2015-1507. Epub 2015 Oct 12. 
 
5. Peng C, Monagle P, Newall F. Clinical outcomes of management of CVAD occlusions. Arch 
Dis Child.2011;96(9):885–887pmid:21398316 
 
6. Rey C, Alvarez F, De La Rua V, et al. Mechanical complications during central venous 
cannulations in pediatric patients. Intensive Care Med. 2009;35(8):1438–1443. 
 
7. Ullman AJ, Cooke M, Rickard CM. Examining the Role of Securement and Dressing Products 
to Prevent Central Venous Access Device Failure: A Narrative Review. JAVA 2015. Vol 20 No 
2: 99-110.