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临床试验/NCT04927325
NCT04927325已完成不适用

Quantification of Erythema at Exit Site of Central Catheter: Is a Tablet Camera Sufficient?

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2021年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Percentage of usable images

研究概览

简要总结

Background: In critical care medicine central venous catheters play an important role in the source of infections. In the daily routine prior to the diagnosis the suspicion of catheter related infection is discussed in the medical team due to signs of systemic inflammation or exit site infection like erythema, induration or tenderness. However, if an erythema at exit site of a central line can be quantified with a tablet camera, is unknown.

Methods: Standardized set of photos will be taken of 10 central lines with a reddened exit site and 10 catheters without an erythema (as a control over time) with a tablet camera and a single-lens reflex camera. The percentage of usable images between tablet and single-lens reflex camera will be analysed. Furthermore, two independent clinical experts from dermatology will grade blinded de-identied images on a scale from 0 to 4 (0 - no erythema, 1- very faint, 2 - faint, 3 - bright, 4 - very bright).

Objectives: The primary objective of this feasibility study aims to analyze the reliability of a tablet camera as a device for quantification of erythema around an exit site.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
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

  • Jugular CVC or Subclavian CVC
  • ICU-Admission

排除标准

  • < 18 years
  • Pregnancy/Lactation
  • neutropenia (<1000/m3)
  • hematologic tumor
  • dark pigmentation
  • prone position within the last 24 hours
  • head/neck-area: cancer, operation, burns or radiation, tattoos

结局指标

主要结局

Percentage of usable images

时间窗: through study completion, an average of 3 months

The percentage of useable images of tablet camera compared with single-lens reflex (SLR) camera will be analysed.

次要结局

  • Quantification of the exit site with regards to an erythema scale(through study completion, an average of 3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Christina Hafner

Clinical Investigator

Medical University of Vienna

研究点 (2)

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