跳至主要内容
临床试验/NCT06905080
NCT06905080进行中(未招募)不适用

Dialysis Catheter Caps Case Feasibility Study

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年3月13日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
Mayo Clinic
入组人数
10
试验地点
1
主要终点
To evaluate the ease and structural integrity of the Catheter Caps Case (C3)

研究概览

简要总结

The purpose of this research is to evaluate patient comfort and ease of an investigational device called Catheter Caps Case (C3) attached to the hemodialysis catheter over a 15-minute period. You have been asked to take part in this research because you have been identified as a dialysis patient with a hemodialysis catheter.

详细描述

Tunneled hemodialysis catheters are commonly used to administer dialysis to patients with kidney failure to remove excess fluid and waste from the blood. Traditionally, the maintenance and protection of these catheters involves the use of gauze and tape to secure the catheter and cover the double lumen and caps. While this method is widely practiced, it has several drawbacks that can affect both patient outcomes and healthcare efficiency.

Firstly, the use of gauze and tape can be uncomfortable for patients. The adhesive nature of the tape can cause skin irritation and allergic reactions, in addition the gauze can impede visualization of the entire length of the catheter. Additionally, the process of routine changing gauze and tape is time-consuming for healthcare providers and can increase the risk of catheter dislodgment during or catheter caps disconnection during removal of tape gauze combination.

Another significant concern is infection control. Gauze and tape do not provide an optimal sterile barrier, which can lead to an increased risk of catheter-related bloodstream infections (CRBSIs). These infections are associated with prolonged hospital stays, higher hospital healthcare costs, and increased patient mobility and mortality.

The catheter caps case was developed to address these issues by providing a more secure and sterile alternative to gauze and tape. The case is designed to cover the catheter's double lumen and end caps, offering added protection and stability. Its innovative design aims to reduce the risk of accidental dislodgement, enhance infection control, and improve overall patient comfort by eliminating the need for gauze and adhesive tape.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with tunneled dialysis catheter that will not be removed in the next 90 days.
  • Patients from the home dialysis program or in-center (outpatient dialysis) patient population.
  • Patients who are age 18 years or older

排除标准

  • Patient-delayed graft function (DGF)
  • Acute kidney injury patients
  • Patients with non-tunneled catheter
  • Allergies to the BioMed Elastic 50A Resin

结局指标

主要结局

To evaluate the ease and structural integrity of the Catheter Caps Case (C3)

时间窗: 1 Day

The feasibility of the catheter cap will be assessed by evaluating its ease of use and structural integrity. This includes measuring the time required for secure placement and removal compared to traditional gauze and tape, as well as obtaining standardized usability ratings from healthcare providers. Additionally, the study will track the incidence of accidental catheter dislodgement during routine cap changes to determine whether the cap provides enhanced stability.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephanie R. Jenkins

Principal Investigator

Mayo Clinic

研究点 (1)

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