Clinical trial NCT04522778: Innovative Central Line Securement Device in the Pediatric Population
Official title: Innovative Central Line Securement Device: Line Complications and Quality of Life in the Pediatric Population as Compared to Traditional Securement Device
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Central Line Complication
Central Line Infection
Central Line-Associated Infection
Central Line Sepsis
Short Gut Syndrome
Quality of Life
Pediatric Disorder
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 23
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Primary Outcome - Line Breaks
timeFrame: For a maximum of 1 year from enrollment
measure: Primary Outcome - Line Replacement
timeFrame: For a maximum of 1 year from enrollment
measure: Primary Outcome - Line Infections
timeFrame: For a maximum of 1 year from enrollment
Secondary outcomes:
measure: How Has the Vest or Dressing Affected Your Ability as a Family to Participate in Daily Activities?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: How Has the Vest or Dressing Affected Your Child's Ability to be Active?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses for an individual was 5 over a 12 month period.
measure: How Has the Vest or Dressing Affected Your Child's Ability to Participate in Typical Activities With Peers or Siblings?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: How Has the Vest or Dressing Affected Your Ability to Keep Your Child's Central Line Safe?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: Have You Been Worried About the Safety of Your Child's Central Line?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: Has Your Child Been Able to Take a Long Walk or Play?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: Has Your Child Been Able to Take a Short Walk Outside of the House?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: Are You Worried About Your Child's Current Health?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: Has Your Child Needed to Stay in Bed or a Chair During the Day?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: Has Your Child Needed Help With Eating, Dressing, Washing or Using the Toilet?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: Is Your Child Able to Socialize?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: Is Your Child Able to do Sports/Exercise?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: Is Your Child Able to Attend School/Pre-school?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: Does Having a Central Line Affect His/Her Participation in School?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: Does Having a Central Line Affect His or Her Learning at School?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: Is Your Child Able to Take Part in Hobbies or Leisure Activities?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: Is Your Child Able to Feel Independent?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: Has the Vest or Dressing Been Easy to Use?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: Has the Vest or Dressing Been Comfortable to Wear?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: Has the Vest or Dressing Kept You Child's Central Line Safe?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: Has the Vest or Dressing Prevented Your Child From Tampering With or Touching the Central Line?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: Has the Vest or Dressing Enabled Your Child to be More Active?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: Has the Presence of a Central Line Affected Their Body Image?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: How Would You Rate Your Child's Quality of Life on a Scale of 1 to 10?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: How Would You Rate Your Child's Ability to Cope With Day to Day Activities?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: How Has Your Child's Quality-of-life Been Affected by Vest or Dressing?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
measure: How Has Your Child's Quality-of-life Been Affected by Their Underlying Illness?
timeFrame: Responses were recorded every Thursday follow up appointment, save for holidays between January 2021 and September 2022. The maximum number of responses of a participant was 5 over a maximum of 12 months.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Children's Hospital of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: UPMC Children's Hospital of Pittsburgh
name: Angelica Mazzarini, MD
role: PRINCIPAL_INVESTIGATOR
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