Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications in Patients With Mechanical Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Pathogen colonization change
研究概览
简要总结
Ventilator-associated pneumonia and ventilator-associated treakeabronchitis in respiratory tract infections associated with ventilator are common infections in intensive care unit and cause significant morbidity, mortality and health expenditures in nosocomial infections. Adequate and effective oral care by nurses in intensive care patients, possible complications, intensive care unit stay in the intensive care unit and is very important in terms of mortality.
详细描述
The aim of this study will (1) evaluate the effect of 0.12% chlorhexidine gluconate on ventilator-associated pneumonia, ventilator-associated treakeabronchitis, (2) determine the effect of preventing microorganism colonization, and (3) assess the mortality rate for each patient and the cost-effectiveness in the health expenditures.
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Admission in critical care with in 24 hours
- •Having an endotracheal tube
排除标准
- •History of chlorhexidine allergy
- •Duration of mechanichal ventilation less than 48 h
- •Confirmed diagnosis of pneumonitis before admission in the ICU
- •Transfer from another ICU
- •Receiving chemotherapy or radiotherapy
- •Patients with immunodeficiency
- •Patients with tracheostomies
- •Required specific oral hygiene procedures
- •Facio-maxillary or dental trauma/surgery
- •Being pregnant
研究组 & 干预措施
Experimental group
0.12% chlorhexidine gluconate
干预措施: 0.12% chlorhexidine gluconate (Drug)
Placebo group
sodium bicarbonate
干预措施: Placebo (Drug)
结局指标
主要结局
Pathogen colonization change
时间窗: change from baseline pathogen colonization at Day 3
We will examine microbiological analyses ( mini-BAL, oropharyngeal and tracheal secretions)
rate of tracheobronchitis change
时间窗: change from baseline the rate of tracheobronchitis at Day 3
Questionary (use the rate of tracheobronchitis categories)
Oral assessment guide score change
时间窗: at the time of admission into the study (day 0), at study day 2 and at day 3
The score ranges from 8 to 24 and higher scores indicating worse oral health
Clinical pulmonary infection score change
时间窗: at the time of admission into the study (day 0), at study day 2 and at day 3
The score ranges from 0 to 12 (ventilator-associated pneumonia ≥ 6 )
次要结局
- Mortality(Day 7 and Day 28)
- cost effectiveness(Day 30)
研究者
Duygu Kes
Principal Investigator
Karabuk University