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临床试验/NCT03809832
NCT03809832终止不适用

Microbiologic Contamination of Home Non Invasive Ventilators

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2019年1月21日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
54
试验地点
1
主要终点
Prevalence of microbial contamination of non invasive ventilators humidifier

研究概览

简要总结

Home non-invasive ventilators are daily used by patients with chronic respiratory failure. There are frequently used with warming and humidifying systems. These systems need to be cared for and frequently washed by the patient.

The aim of this study is to evaluate if the humidifying system of home ventilators are colonized by microbiological germs.

详细描述

The use of non-invasive ventilators is common for treating respiratory failure. Their care relies on the patients and their carers.

No study has assessed the efficacy of such care with respect to the number of microbiological specimens that remain in the humidifier.

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 established on home non invasive ventilation for more than 6 months
  • With a compliance >4hours/day
  • Who brought their ventilator for the assessment
  • Diagnosed with COPD or Obesity hypoventilation syndrome (OHS)
  • Who consent
  • With an age > 18 years

排除标准

  • Age under 18
  • Ongoing exacerbation
  • Not able to consent
  • Pregnant or breastfeeding

结局指标

主要结局

Prevalence of microbial contamination of non invasive ventilators humidifier

时间窗: 7 days

次要结局

  • Microbiological ecology in the study population(7 days)
  • Comparison between COPD and Obesity hypoventilation syndrome patients microbial ecology(7 days)
  • Compliance to recommendations regarding the maintenance of the humidifier(7 days)
  • Correlation between compliance to maintenance recommendations and contamination rate(7 days)
  • Comparison of exacerbation frequency in COPD patients and isolation of respiratory pathogens in the humidifier(12 months)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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