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临床试验/NCT02400294
NCT02400294已完成不适用

Prevention of Ventilator Associated Pneumonia With Toothbrushing in Oral Care of Critically Ill Mechanically Ventilated Patients

University Hospital, Clermont-Ferrand1 个研究点 分布在 1 个国家目标入组 2,030 人开始时间: 2014年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
2,030
试验地点
1
主要终点
Nosocomial ventilator associated pneumonia

研究概览

简要总结

Effect of toothbrushing in oral care of mechanically ventilated critically ill patients on prevention of ventilator associated pneumonia

详细描述

Prospective, before and after study in 5 Intensive Care Units (ICUs) of a university hospital.

The before period (control phase, 6 months): standard oral care 3 times a day in every consecutive intubated patients in the participating ICUs The interphase period (1 month): formal training of all the nurses, physicians and residents on the use of toothbrushing during oral care The after period: (study phase, 6 months): standard oral care with tooth brushing 3 times a day in every consecutive intubated patients in the participating ICUs

研究设计

研究类型
Observational
时间视角
Cross Sectional

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

  • Adult patients
  • Intubated mechanically ventilated ICU patient
  • Platelets count >50G/L

排除标准

  • Edentulous patients

结局指标

主要结局

Nosocomial ventilator associated pneumonia

时间窗: at Day-28

Presence of at least two signs (body fever greater than 38°C; leukocytosis greater than 12000/ml or leukopenia below 4000/ml, purulent pulmonary secretions) associated with the appearance of a new infiltrate or modification of an existing infiltrate on chest-X-ray. Confirmation by a lower respiratory tract sample using a quantitative culture with a predefined positive threshold. Hospital-acquired pneumonia was defined as a pneumonia that occurs at least 48 hours after admission, which was not incubating at time of admission (Am J Respir Crit Care Med 2005; 171, 388-416).

次要结局

  • Hospital mortality(at Day-90)
  • ICU length of stay(at Day-90)
  • ICU mortality(at Day-90)
  • Tracheobronchitis(at Day-28)
  • Antibiotic free days(at Day-90)

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (1)

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