Oral Health and Ventilator Associated Pneumonia

描述(由申请人提供)：最近的研究发现，糟糕的口腔卫生可能会促进机械通气(MV)重症监护病房(ICU)患者口咽部潜在呼吸道病原体的定植。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)。修订后的申请的具体目的是：1)组织必要的基础设施来开发和进行试点临床试验，以评估预防VAP的替代口腔卫生措施；2)利用该组织进行试点临床试验，以确定口服外用葡萄糖酸氯己定(CHX)是否将预防MV-ICU患者的牙菌斑、呼吸道病原体定植和VAP。这项先导性纵向、双盲干预研究将考虑适当的CHX给药频率，以改善MV-ICU患者的口腔卫生。这些先导性研究的初步数据还将为大规模多中心临床试验提供准确的样本量计算；以及3)对患有或不患有VAP的MV-ICU患者下呼吸道分泌物中培养的遗传型细菌菌株进行分子流行病学研究，并将它们与从他们的牙菌斑中分离的相同物种的菌株进行比较。 这项先导性研究将使这个多学科研究团队能够组织执行多中心对照临床试验所需的基础设施、患者招募和方法学方案以及数据管理和分析程序，以评估这一干预措施的有效性和普适性，以改善MV-ICU的口腔卫生并预防VAP。

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.