ORAL CARE INTERVENTION IN MECHANICALLY VENTILATED ADULTS

描述：（由申请人提供）肺炎是导致死亡的主要原因 医院感染气管插管和机械通气 增加细菌性呼吸机相关性肺炎（VAP）的风险。增长 危重病人牙菌斑中潜在致病菌的研究 为微生物提供了一个感染病灶， 负责VAP的开发。由于这些生物体集中在 在牙菌斑中，通过口腔护理从口腔中去除微生物 干预是一种理论上有吸引力的方法，以减少风险， VAP的发展。然而，基于证据的口腔护理方案， 没有机械通气的病人。因此，我们提出一个 前瞻性随机临床试验，以测试三种口腔护理的效果 干预（机械，MECHI;药理，PHARMI;和组合， 机械加药理学，COMBI）在降低VAP发生风险方面的作用。 本研究的主要目的是测试机械， 药物和组合（机械加药物）口腔护理 干预对牙菌斑、口腔植物群和口腔免疫的影响 重症机械通气成人。第二个目的是检查 机械、药理学和组合（机械加 药物）口腔护理干预对危重病患者VAP发生的影响 机械通气成人;和2）描述任何不同的影响 机械和药物口腔护理干预对VAP发展的影响 在特定的患者人群中（内科、外科和神经科危重患者）， 病人）。共456例受试者将被随机分配至4组 （对照品、MECHI、PHARMI、COMBI），以获得足够的样本量， 300个实验对象干预措施的效果将使用 受试者间22因子设计。将进行双因素方差分析 用于进行显著性检验，包括对每个 干预（MECHI、PHARMI和COMBI）对牙菌斑结果的影响 （UM-OHI评分）、口腔免疫（唾液伊加和乳铁蛋白）、口腔植物群 （半定量培养）和VAP的发展（CPIS评分）。结果 该研究有可能对患者的健康产生积极影响， 发病率、死亡率和保健费用。

DESCRIPTION: (provided by applicant) Pneumonia is the leading cause of death from nosocomial infections. Intubation and mechanical ventilation greatly increase the risk of bacterial ventilator-associated pneumonia (VAP). Growth of potentially pathogenic bacteria in dental plaque of critically ill patients provides a nidus of infection for microorganisms that have been shown to be responsible for the development of VAP. Since these organisms are concentrated in dental plaque, removal of organisms form the oral cavity by oral care interventions is a theoretically attractive method to reduce the risk of development of VAP. However, evidence-based protocols for oral care of mechanically ventilated patients are not available. Thus, we propose a prospective, randomized clinical trial to test the effects of three oral care interventions (mechanical, MECHI; pharmacologic, PHARMI; and combination, mechanical plus pharmacologic, COMBI) in reducing the risk of developing VAP. The primary aim of this study is to test the effects of mechanical, pharmacologic and combination (mechanical plus pharmacologic) oral care interventions on dental plaque, oral microbial flora and oral immunity in critically ill mechanically ventilated adults. Secondary aims are to1) examine the effects of mechanical, pharmacologic and combination (mechanical plus pharmacologic) oral care interventions on development of VAP in critically ill mechanically ventilated adults; and 2) describe any differential effects of mechanical and pharmacologic oral care interventions on the development of VAP in specific patient populations (medical, surgical, and neurologic critically ill patients). A total of 456 subjects will be randomly assigned to 4 groups (control, MECHI, PHARMI, COMBI) in order to attain an adequate sample size of 300 subjects. The effects of interventions will be examined using a between-subjects 22 factorial design. A two-factor analysis of variance will be used to conduct significance tests, including tests of the effect of each intervention (MECHI, PHARMI, and COMBI) on the outcomes of dental plaque (UM-OHI score), oral immunity (salivary IgA and lactoferrin), oral flora (semi-quantitative culture), and development of VAP (CPIS score). Results of the study have the potential to positively affect patient well-being, morbidity, mortality and health care costs.