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临床试验/NCT06216080
NCT06216080已完成不适用

Dynamic Full-Field Optical Coherence Tomography for Structural and Microbiological Characterization of Central Venous Catheter-deposited Biofilm in Critically Ill Patients

Centre Hospitalier William Morey - Chalon sur Saône1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
D-FF-OCT-based biofilm structure type

研究概览

简要总结

29.3% of bacteremias in intensive care units (ICU) are linked to vascular devices, with a significant proportion related to central venous catheters, and an influence on both morbility and mortality.

It is now accepted that microbiological biofilm plays a key role on both bacterial and fungal development on inner surface of vascular devices but there is yet a lack of clinical relevant data documenting a causal relation between biofilm formation and bacteremias.

We assume that a more precise characterization of central venous catheter-deposited biofilm could help us better understand invasive medical device-related healthcare infections in critically ill patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patient or relative informed of the study and having declared their nonobjection
  • Patient over 18 years of age
  • Patient exposed to central venous catheter for at least two calendar days

排除标准

  • Patient unable to declare their nonobjection
  • Patient whose central venous catheter collection is impossible
  • Patient admitted in ICU with a central venous catheter already in place

结局指标

主要结局

D-FF-OCT-based biofilm structure type

时间窗: At Day 0, within 24h following catheter removal

Biofilm structure type (ribbon-shaped or mushroom-shaped), measured with D-FF-OCT

次要结局

  • D-FF-OCT-based biofilm thickness(At Day 0, within 24h following catheter removal)
  • D-FF-OCT-based dynamic signal distribution(At Day 0, within 24h following catheter removal)

研究者

发起方
Centre Hospitalier William Morey - Chalon sur Saône
申办方类型
Other
责任方
Sponsor

研究点 (1)

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