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临床试验/NCT04323150
NCT04323150已完成不适用

The Effect of Closed Suction System on the Incidence of Ventilator-associated Pneumonia, Respiratory-associated Microbiome and Contamination of Inanimate Surfaces: a Pilot Study.

Northern State Medical University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2018年2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
40
试验地点
2
主要终点
incidence of the ventilator - associated pneumoniae (VAP)

研究概览

简要总结

The investigators are suggesting that closed suction systems may reduce the risk of the ventilator - associated pneumoniae (VAP) and the contamination of the closest unanimated surfaces. In 2011 David et al. have shown that closed suction systems might reduce the incidence of the late VAP. Research team is thinking that preventive bundle with closed suction systems can prevent to onset of the VAP. All enrolled patients is randomizing into two groups: control group - conventional suctioning and research group - suctioning with closed suction system.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

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

  • invasive mechanical ventilation beyond 48 hours

排除标准

  • hospital - acquired pneumonia
  • community - acquired pneumoniae
  • BMI > 35 kg/cm2
  • pregnancy
  • tracheostomy

结局指标

主要结局

incidence of the ventilator - associated pneumoniae (VAP)

时间窗: Change from Baseline CPIS at 96 hours

Assessment of CPIS, if CPIS equal or more 6 points VAP will be observed

Contamination of closet inanimate surfaces

时间窗: Change from Baseline Microbiology researching at 96 hours

Microbiology researching samples from circuit of a respirator and a bed

次要结局

  • Organ dysfunction(Change from Baseline SOFA at 96 hours)
  • sTREM 1(Change from Baseline CRP researching at 96 hours)
  • Mortality(28 days)
  • C - reactive protein(Change from Baseline CRP researching at 96 hours)
  • Procalcitonin(Change from Baseline CRP researching at 96 hours)

研究者

发起方
Northern State Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vsevolod V. Kuzkov

Professor of the Department of Anaesthesiology and Intensive Care Medicine, MD, PhD

Northern State Medical University

研究点 (2)

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