Oral Health and Ventilator Associated Pneumonia

描述（由申请人提供）：最近的研究发现，口腔卫生不良可能会促进机械通气（MV）重症监护室（ICU）患者的潜在呼吸道病原体在口咽部定植。因此，改善MV-ICU患者的口腔卫生可以预防呼吸机相关性肺炎（VAP）。本修订申请的具体目的是：1）组织必要的基础设施，以开发和执行试点临床试验，以评估预防VAP的替代口腔卫生程序; 2）利用该组织进行试点临床试验，以确定使用口服局部葡萄糖酸氯己定（CHX）是否会预防牙菌斑，呼吸道病原体的口咽定植，MV-ICU患者中VAP的发生率。这项纵向、双盲干预试验将考虑适当的CHX给药频率，以改善MV-ICU患者的口腔卫生。 这些初步研究的初步数据还将允许为大规模多中心临床试验进行准确的样本量计算;以及3）对从有或没有VAP的MV-ICU患者的下气道分泌物培养的细菌菌株进行分子流行病学研究，并将其与从其牙菌斑分离的相同物种的菌株进行比较。 这项试点研究将使这个多学科的研究人员团队能够组织基础设施，患者招募和方法学方案，以及进行多中心对照临床试验所需的数据管理和分析程序，以评估这种干预措施改善MV-ICU口腔卫生和预防VAP的有效性和普遍性。

DESCRIPTION (provided by applicant): Recent studies have found that poor oral hygiene may foster the colonization of the oropharynx by potential respiratory pathogens in mechanically-ventilated (MV), intensive care unit (ICU) patients. Thus, improvements in oral hygiene in MV-ICU patients may prevent ventilator-associated pneumonia (VAP). The Specific Aims of this revised application are: 1) to organize the necessary infrastructure to develop and perform a pilot clinical trial to evaluate alternative oral hygiene procedures to prevent VAP; 2) to use this organization to perform a pilot clinical trial to determine if the use of oral topical chlorhexidine gluconate (CHX) will prevent dental plaque, oropharyngeal colonization by respiratory pathogens, and VAP in MV-ICU patients. This pilot longitudinal, double blind intervention study will consider the appropriate frequency of delivery of CHX to improve oral hygiene in MV-ICU patients. Preliminary data from these pilot studies will also allow accurate sample size calculations to be made for a large scale multi-center clinical trial; and 3) to perform molecular epidemiological studies to genetically type bacterial strains cultured from lower airway secretions of MV-ICU patients with or without VAP and compare them to strains of the same species isolated from their dental plaque. This pilot study will enable this multidisciplinary team of investigators to organize the infrastructure, patient recruitment and methodologic protocols, and data management and analysis procedures necessary to perform a multi-center, controlled clinical trial to assess the efficacy and generalizability of this intervention to improve oral hygiene in MV-ICU and prevent VAP.