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临床试验/NCT05146817
NCT05146817Unknown不适用

Original Protocol of Oral Cavity Care During Long-term Mechanical Ventilation : Microbiological and Clinical Effects

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Microbial growtn

研究概览

简要总结

This is a prospective open label randomized controlled trial of the efficacy of original oral care protocol for prevention of ventilator-associated pneumonia (VAP) and ventilator-associated tracheobronchitis (VAT)in adult patients mechanically ventilated for at least 3 days

详细描述

The study aims to clarify the effect of of the original method of oral cavity care in adult patients of intensive care units on long-term mechanical ventilation due to the assessment of the microbiological landscape of the oral cavity, oral plaque, upper and lower respiratory tract, the incidence of ventilator-associated pneumonia (VAP) and ventilator-associated tracheobronchitis (VAT) , depending on the traditional or original protocol of the oral cavity care. Ventilator associated pneumonia is associated with significant morbidity and mortality.Inadequate oral hygiene in intensive care units (ICUs) has been recognized as a critical issue, for it is an important risk factor for ventilator associated pneumonia (VAP). VAP is an aspiration pneumonia that occurs in mechanically ventilated patients, mostly caused by bacteria colonizing the oral cavity and dental plaque. It has been suggested that improvement of oral hygiene in ICU patients could lead to a reduced incidence of VAP. Although diverse oral care measures for ICU patients have been proposed in the literature, there is no evidence that could identify the most efficient ones. Although there are several evidence-based protocols, oral care measures are still performed inconsistently and differ greatly between individual ICUs.The influence of tooth brushing to maintain good oral health in the general population has long been standard practice. However the effect of brushing in the mechanically ventilated and intubated critically ill patients to dislodge organisms from dental plaque remains largely unclear

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
None

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

  • Age of 18 years or more;
  • Mechanical ventilation more than 24 hours;
  • Expected length of mechanical ventialtion more than 72 hours;

排除标准

  • Aspiration at the prehospital stage
  • Community-acquired pneumonia
  • COPD or specific lung diseases
  • Сhest Injury
  • Hemo and \or pneumothorax
  • Fat embolism
  • Lung cancer
  • Severe renal and\or hepatic impairment
  • Blood platelets less than 50 000 / μl
  • Pregnancy and the period of breastfeeding;
  • Other circumstances that the researcher considers inappropriate to participate in this study

结局指标

主要结局

Microbial growtn

时间窗: 14 days

Oral and tracheal microbial growth/inhibition

次要结局

未报告次要终点

研究者

发起方
Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
申办方类型
Other
责任方
Sponsor

研究点 (2)

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