Innovative Central Line Securement Device in the Pediatric Population

NCT ID: NCT04522778

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-05
• Study Completion Date: 2023-05-01

Brief Summary

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

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Device

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.

Group Type: EXPERIMENTAL

Wearable Central Line Securement Device (Vest)

Intervention Type: DEVICE

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.

Traditional Securement Dressing

Intervention Type: OTHER

All subjects will use sterile dressings throughout the trial as this is the standard of care for central line securement. Subjects randomized to the dressing arm will continue to use standard of care sterile dressing as the only form of central line securement.

Traditional Securement Dressing

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

Group Type: ACTIVE_COMPARATOR

Traditional Securement Dressing

Intervention Type: OTHER

All subjects will use sterile dressings throughout the trial as this is the standard of care for central line securement. Subjects randomized to the dressing arm will continue to use standard of care sterile dressing as the only form of central line securement.

Interventions

Wearable Central Line Securement Device (Vest)

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.

Intervention Type: DEVICE

Traditional Securement Dressing

All subjects will use sterile dressings throughout the trial as this is the standard of care for central line securement. Subjects randomized to the dressing arm will continue to use standard of care sterile dressing as the only form of central line securement.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 0 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ryan St. Pierre-Hetz

OTHER

Sponsor Role: lead

Responsible Party

Ryan St. Pierre-Hetz

Pediatric Emergency Medicine Attending

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Angelica Mazzarini, MD

Role: PRINCIPAL_INVESTIGATOR

UPMC Children's Hospital of Pittsburgh

Locations

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States

Countries

United States

References

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STUDY19010059

Identifier Type: -

Identifier Source: org_study_id