Efficacy of Mouth-rinse With Chlorhexidine for the Prevention of Ventilator-associated Infections in Intensive Care Unit
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Cumulative incidence of Infections Associated with Mechanical Ventilation.
研究概览
简要总结
Background:
Infections associated with mechanical ventilation are associated with high rates of morbidity and mortality, which results not only in an increase in hospitalization days and care costs, but also in an increase in DALYS (years of life disability adjustment) in the population.
Critically ill patients have a high risk of infection as a result of underlying immunodeficiency, comorbidity and placement of invasive devices (such as endotracheal tubes and intravascular devices). Infections in these patients constitute a challenge for hospital authorities, as they are considered a social and economic problem that influences the quality of care, in a system where health services are increasingly affected by high patient care costs and the reduction of public spending.
The decrease in the number of bacteria in the oral cavity reduces the presence of microorganisms available for translocation and colonization of the lower respiratory tract; Therefore, performing oral care intervention is considered an economically attractive method to reduce the risk of developing infections associated with endotracheal intubation.
In our environment, oral cleaning is performed as part of the nursing care package granted to all patients of the ICU, however, there is no standardized method among nursing staff that guarantees the desired prevention.
Objective: To evaluate the efficacy and safety of mouth-rinse with 0.12% chlorhexidine to prevent infections associated with mechanical ventilation in patients in the intensive care unit in a third level hospital in Mérida, Yucatán.
Hypothesis: Mouth-rinse with 0.12% chlorhexidine twice daily more effective and safe than mouthwash with bicarbonated isotonic solution twice daily to prevent infections associated with mechanical ventilation in patients in the intensive care unit of a hospital third level.
Methodology: Double-blind randomized controlled clinical trial with active substance for the evaluation of the non-inferiority of the efficacy and safety of mouthwash with 0.12% chlorhexidine twice daily compared to isotonic bicarbonated solution twice daily for the prevention of any infection associated with mechanical ventilation in patients requiring endotracheal intubation in the intensive care unit of a third level hospital.
详细描述
Eligibility criteria Adult patients admitted to the ICU will be included, with less than 24 hours of endotracheal intubation due to mechanical ventilation requirements, whose responsible family member gives informed consent.
Patients with known hypersensitivity or contraindications for the use of oral chlorhexidine, patients with a diagnosis of admission to the ICU of any respiratory tract infection, toothless patients and pregnant patients will be excluded.
Patients who, during their stay in ICU, require tracheostomy after having endotracheal intubation and those who decide to withdraw their informed consent will be eliminated from the active phase.
Adverse events surveillance During the period of the permanence of the subject in the clinical trial, daily monitoring of adverse events and the response variable will be carried out, taking information from the clinical record, the results of cultures performed on the patient and supplemented with hospital surveillance reports.
Treatment assignation According to the randomization of the subject, a bottle of mouthwash labeled with the clinical trial data will be assigned for personal use.
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
- Double (Participant, Care Provider)
盲法说明
All mouth-rinse bottles will have the same external appearance, being plastic bottles with integrated spray atomizer and protective plastic cap. Each bottle will have a unique folio for identification printed on the identification label.
The clinical staff working in the Hospital and having contact with the study subjects will be blinded at all times to the care group assigned to the patient.
Academic staff working outside the Hospital and will not have direct contact with the study subjects, will not be blinded to the assigned group, in order to administer a second bottle of treatment if necessary.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients admitted to the ICU will be included, with less than 24 hours of endotracheal intubation due to mechanical ventilation requirements, whose responsible family member gives informed consent.
排除标准
- •Patients with known hypersensitivity or contraindications for the use of oral chlorhexidine, patients with a diagnosis of admission to the ICU of any respiratory tract infection, toothless patients and pregnant patients.
结局指标
主要结局
Cumulative incidence of Infections Associated with Mechanical Ventilation.
时间窗: Developed during the period of permanence of endotracheal intubation procedure and up to 48 hours after its withdrawal
New cases of respiratory infections (except pneumonia) developed in susceptible individuals entering the study, during the period of the study.
Cumulative incidence of Pneumonia Associated with Mechanical Ventilation
时间窗: Developed during the period of permanence of endotracheal intubation procedure and up to 48 hours after withdrawal
New cases of pneumonia associated with mechanical ventilation developed in susceptible individuals entering the study, during the period of the study.
次要结局
未报告次要终点