Innovative Central Line Securement Device in the Pediatric Population

Ryan St. Pierre-Hetz

Status: Terminated

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

Treatments: Other: Traditional Securement Dressing; Device: Wearable Central Line Securement Device (Vest)

Study type: Interventional

Funder types: Other

Identifiers

NCT04522778

STUDY19010059

Details and patient eligibility

About

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).

Full description

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. Events per month would be calculated for each arm before and after intervention and analyzed for treatment effect. 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. This will be analyzed with a standardized quality of life survey and treatment effect will be reported as an ordinal odds ratio. 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.

Enrollment: 23 patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

Device

Experimental group

Description:

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.

Treatment:

Device: Wearable Central Line Securement Device (Vest)

Other: Traditional Securement Dressing

Traditional Securement Dressing

Active Comparator group

Description:

Those is the non-device arm will continue to wear a traditional central line securement dressing as is the standard of care.

Treatment:

Other: Traditional Securement Dressing