跳至主要内容
临床试验/NCT06838598
NCT06838598招募中不适用

Structural and Microbiological Characterization of Arterial Catheter Biofilm in ICU's Patients Using Optical Coherence Tomography

Centre Hospitalier William Morey - Chalon sur Saône2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Biofilm structure type (ribbon-shaped or mushroom-shaped), measured with D-FF-OCT

研究概览

简要总结

29.3% of bacteremias in intensive care units (ICU) are linked to vascular devices, including 7.7% to arterial catheters, with an influence on both morbility and mortality.

It is now accepted that biofilm as a role on bacterial 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.

The investigators assume that a better structural and microbiological characterization of arterial catheter biofilm in ICU patients could help preventing bacteremias or have a more specific treatment when it appears.

研究设计

研究类型
Observational
观察模型
Other
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
否

入选标准

  • •Patient or relative informed of the study and having declared their non-objection
  • •Patient over 18 years old
  • •Patient hospitalized in ICU with an arterial catheter

排除标准

  • •Patient unable to express consent
  • •Patient whose collection of the arterial catheter is impossible or for whom storage at 4°C is impossible
  • •Patient with arterial catheter removed outside the usual procedure of the ICU
  • •Patient admitted in ICU with an arterial catheter already in place

研究组 & 干预措施

OCT-BIO-KTA cohort

Critically ill patient > 18 years of age with artherial catheter for >2 calendar days in ICU

干预措施: OCT-BIO-KTA cohort (Other)

结局指标

主要结局

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

时间窗: Outcome measure is assessed 2 days following catheter removal

Provide a better understanding of the relation between structural and microbiological characterization of artherial catheter biofilm in ICU patients using D-FF-OCT

次要结局

  • Bacterial or fungal indentification(Outcome measure is assessed 2 days following catheter removal)
  • Biofilm thickness, measured with D-FF-OCT(Outcome measure is assessed 2 days following catheter removal)
  • Biofilm dynamic signal distribution, measured with D-FF-OCT(Outcome measure is assessed 2 days 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 (2)

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