NCT04522778终止不适用
Innovative Central Line Securement Device: Line Complications and Quality of Life in the Pediatric Population as Compared to Traditional Securement Device
Ryan St. Pierre-Hetz2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2020年11月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Primary Outcome - Line Breaks
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Primary Outcome - Line Breaks
时间窗: For a maximum of 1 year from enrollment
Number of line breaks defined as any mechanical trauma to the line that required repair but not replacement of the line.
Primary Outcome - Line Infections
时间窗: For a maximum of 1 year from enrollment
Number of line infections defined as a positive blood culture drawn from a central line.
Primary Outcome - Line Replacement
时间窗: For a maximum of 1 year from enrollment
Number of line replacements in which a line was removed from the patient and a new line was placed.
次要结局
- Have You Been Worried About the Safety of Your Child's Central Line?(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.)
- Has Your Child Needed Help With Eating, Dressing, Washing or Using the Toilet?(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.)
- How Has the Vest or Dressing Affected Your Child's Ability to Participate in Typical Activities With Peers or Siblings?(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.)
- How Has the Vest or Dressing Affected Your Ability to Keep Your Child's Central Line Safe?(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.)
- Are You Worried About Your Child's Current Health?(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.)
- How Has the Vest or Dressing Affected Your Child's Ability to be Active?(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.)
- Has Your Child Been Able to Take a Long Walk or Play?(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.)
- Has the Vest or Dressing Enabled Your Child to be More Active?(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.)
- How Has the Vest or Dressing Affected Your Ability as a Family to Participate in Daily Activities?(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.)
- Has Your Child Been Able to Take a Short Walk Outside of the House?(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.)
- Has Your Child Needed to Stay in Bed or a Chair During the Day?(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.)
- Is Your Child Able to Socialize?(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.)
- Does Having a Central Line Affect His or Her Learning at School?(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.)
- Is Your Child Able to Take Part in Hobbies or Leisure Activities?(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.)
- Is Your Child Able to do Sports/Exercise?(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.)
- How Would You Rate Your Child's Ability to Cope With Day to Day Activities?(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.)
- How Has Your Child's Quality-of-life Been Affected by Vest or Dressing?(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.)
- How Has Your Child's Quality-of-life Been Affected by Their Underlying Illness?(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.)
- Is Your Child Able to Attend School/Pre-school?(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.)
- Does Having a Central Line Affect His/Her Participation in School?(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.)
- Is Your Child Able to Feel Independent?(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.)
- Has the Vest or Dressing Prevented Your Child From Tampering With or Touching the Central Line?(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.)
- How Would You Rate Your Child's Quality of Life on a Scale of 1 to 10?(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.)
- Has the Vest or Dressing Been Easy to Use?(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.)
- Has the Vest or Dressing Been Comfortable to Wear?(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.)
- Has the Vest or Dressing Kept You Child's Central Line Safe?(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.)
- Has the Presence of a Central Line Affected Their Body Image?(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.)
研究者
Ryan St. Pierre-Hetz
Pediatric Emergency Medicine Attending
University of Pittsburgh
研究点 (2)
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