Oral Chlorhexidine effect on ICU mortality and ventilator-associated pneumonia

描述(申请人提供)：院内肺炎是第二常见的医院获得性感染和最常见的重症监护病房感染。它与严重的发病率和死亡率有关。吸入口咽内容物被认为是肺炎的主要危险因素，特别是在机械通气患者中。口服抗菌剂如洗必泰的应用是否能降低普通重症监护病房患者患肺炎的风险仍存在争议。拟议的第三阶段临床试验将是一项为期五年的、四中心安慰剂对照的随机临床试验，以洗必泰口服作为干预。这项研究将通过使用经过充分验证的主要结果的临床和评分标准来扩展先前在一般ICU人群研究样本中的发现。拟议的试验将评估对照组和干预组患者呼吸机相关肺炎(VAP)和/或死亡率的综合主要结果。需要两年的规划拨款，以完善研究设计和方法，制定操作程序手册，完善患者招募方法，组织潜在的研究中心，使方法和诊断标准标准化，并建立行政和监测委员会。来自四个临床地点和数据协调中心的人员将作为临床试验计划委员会的一部分参与这些活动。第三阶段临床试验将是第一个适当评估口服洗必泰对肺炎和/或死亡率的影响以及具有各种ICU入院指征(包括外科、内科和神经科)的机械通气患者的相关发病率结果的结果研究。这可能会为改变卫生保健政策提供证据，因为它表明一种简单、廉价的口腔保健预防性干预可以降低与医院内肺炎相关的发病率、死亡率和成本。

DESCRIPTION (provided by applicant): Nosocomial pneumonia is the second most common hospital-acquired infection and most common intensive care unit infection. It is associated with significant morbidity and mortality. Aspiration of oropharyngeal contents is considered a major risk factor for pneumonia, especially in mechanically ventilated patients. Whether application of oral antimicrobial agents such as chlorhexidine reduces the risk of pneumonia in the general intensive care unit patient population remains controversial. The proposed Phase III clinical trial will be a five-year, four-center placebo-controlled randomized clinical trial with a chlorhexidine oral application as the intervention. The research will extend previous findings in a general ICU population study sample by using well-validated clinical and scoring criteria for major outcomes. The proposed trial will be powered to evaluate a composite primary outcome of ventilator-associated pneumonia (VAP) and/or mortality with 535 patients in the control group and 535 patients in the intervention group. A 2 year planning grant is requested to refine the study design and methodology, develop a Manual of Operating Procedures, refine patient recruitment approaches, organize potential study centers for standardization of approach and diagnostic criteria, and establish administrative and monitoring committees. Personnel from the four clinical sites and the data coordinating center will participate in these activities as part of the Clinical Trial Planning Committee. The Phase III clinical trial would be the first outcome study properly powered to evaluate the effect of chlorhexidine oral application on pneumonia and/or mortality, and associated morbidity outcomes in mechanically ventilated patients with various indications for ICU admission (including surgical, medical, and neurological). It may provide evidence for changing health care policy by showing that a simple, inexpensive oral care preventive intervention reduces the morbidity, mortality, and costs associated with nosocomial pneumonia.