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临床试验/NCT03105414
NCT03105414Unknown不适用

Etude INCIPAVE: INCidence Des Pneumopathies Acquises Sous Ventilation Chez l'Enfant

Sylvie Chevret1 个研究点 分布在 1 个国家目标入组 2,100 人开始时间: 2017年4月3日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
2,100
试验地点
1
主要终点
Incidence of ventilator acquired pneumonia

研究概览

简要总结

Rationale : ventilator associated pneumonia (VAP) has been extensively studied in adults, however, few data exist regarding VAP in the paediatric intensive care population. The Centers for Disease Control (CDC) definition for VAP is regularly updated trying to homogenised practice, and the last version for paediatrics has been published in 2015. According to the latest CDC definition, the investigators aim to study incidence of VAP in different paediatric intensive care units (PICUs), diagnostic methods of identifying VAP, microbiology of VAP, and utilisation of empirical antimicrobial therapy.

Methods and population : a prospective multicentre observational study will be conducted in European PICUs for one year. All patients admitted to PICU aged more than 28 days and < 18 years, mechanically ventilated either by endotracheal or tracheostomy tube are included. Clinical data, ventilation settings, and risk factors for VAP are inserted daily in an electronic database on the internet. The investigators are going to identify patients, who presented one or more episodes of VAP during PICUs stay, analysing onset circumstances, diagnostic methods, bacteria pathogens identified, and antibiotic treatment. VAP incidence will be reported as number of events per 1,000 ventilator-days. Risk factors associated to VAP will be identified by univariate and multivariate analysis.

Results and perspective : the investigators aim to define for the first time the incidence of VAP among European PICUs with a prospective and multicentre study. The identification of risk factors, diagnostic methods, epidemiology, treatment strategies will define the basis to start prevention manoeuvres and improve the clinical strategies for VAP in paediatric intensive care population.

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
28 Days 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Admitted to Pediatric Intensive Care Unit
  • Aged more than 28 days and < 18 years
  • Mechanically ventilated either by endotracheal or tracheostomy tube

排除标准

  • 未提供

结局指标

主要结局

Incidence of ventilator acquired pneumonia

时间窗: Until weaning of ventilator or 1 year

CDC definition of ventilator acquired pneumonia

次要结局

  • Bacteria prevalence of ventilator acquired pneumonia(Until weaning of ventilator or 1 year)
  • prevalence of diagnostic devices used to identify ventilator acquired pneumonia(Until weaning of ventilator or 1 year)

研究者

发起方
Sylvie Chevret
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sylvie Chevret

Professor

Assistance Publique - Hôpitaux de Paris

研究点 (1)

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