Quantification of Erythema at Exit Site of Central Catheter: Is a Tablet Camera Sufficient?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 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
- 否
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
研究组 & 干预措施
central line with a reddened exit site
A standardized set of photos will be taken of 10 central lines with an erythema at exit site (visible to the naked eye)
干预措施: Set of Photos (Other)
Control Group: central line without a reddened exit site
A standardized set of photos will be taken of 10 newly inserted CVC (as a control over time to evaluate the in-patient redness and the impact of irritation of a CVC)
干预措施: Set of Photos (Other)
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
Christina Hafner
Clinical Investigator
Medical University of Vienna