ORAL CARE INTERVENTION IN MECHANICALLY VENTILATED ADULTS

描述：(申请人提供)肺炎是导致死亡的主要原因 死于医院感染。插管和机械通气量大 增加细菌性呼吸机相关肺炎(VAP)的风险。增长 危重患者牙菌斑中潜在致病菌的检测 为微生物提供了感染的病灶，这些微生物已被证明 负责VAP的开发。因为这些生物是集中的 在牙菌斑中，通过口腔护理去除口腔中的微生物 从理论上讲，干预是一种有吸引力的方法，可以降低 VAP的发展。然而，用于口腔护理的循证方案 没有机械通气机的患者。因此，我们提出一种 三种口腔护理效果的前瞻性随机临床试验 干预措施(机械的，机械的；药理的，PHARMI的；以及联合的， 机械加药物(COMBI)可降低发生VAP的风险。 这项研究的主要目的是测试机械， 药理学和组合式(机械加药理学)口腔护理 干预措施对儿童牙菌斑、口腔菌群和口腔免疫的影响 机械通风严重不良的成年人。次要目标是1)检查 机械作用、药理作用和联合作用(机械加 药理学)口腔护理干预对危重病患者VAP发生的影响 机械通风成人；2)描述任何不同的影响 机械和药理学口腔护理干预对VAP发生的影响 在特定的患者群体中(内科、外科和神经科危重患者 病人)。总共456名受试者将被随机分配到4组 (CONTROL，MECHI，PHARMI，COMBI)，以获得足够的样本量 300名受试者。干预措施的效果将使用 受试者间22个析因设计。双因素方差分析将是 用于进行显着性测试，包括对每个变量的效果进行测试 干预(Mechi、PHARMI和COMBI)对牙菌斑结局的影响 (um-ohi评分)、口服免疫(唾液免疫球蛋白和乳铁蛋白)、口腔菌群 (半定量培养)和VAP(CPIS评分)的发展。结果： 这项研究有可能对患者的健康产生积极影响， 发病率、死亡率和医疗费用。

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.