Oral Care Intervention in Mechanically Ventilated Adults

描述(由申请人提供)：尽管护士刷牙在床边护理中的重要地位，但几乎没有证据来判断护士管理的刷牙对机械通气成人的益处或相关风险，而且在危重的IL中刷牙的最佳频率从未通过实验确定。该项目将通过一项关于刷牙频率(每天一次、两次或三次)的随机临床试验来完成对机械通气成人的口腔护理干预措施的检查，重点是最终确定不同频率的益处和风险，并确定缓和患者水平的风险和益处的因素。该项目的总体目标是确定机械通风成人的最佳刷牙频率。合理的刷牙频率对于控制牙菌斑和减少口腔炎症非常重要，它可能会改善患者的舒适度，提高护理效率，并可能减少与口腔炎症相关的全身后遗症。拟议项目的主要目的是：1)评估三种刷牙频率对接受机械通气的危重成人的口腔健康(牙菌斑和粘膜炎症)的临床等效性(非劣性)；以及2)量化和比较三种刷牙频率对严重不良后果的安全性，包括呼吸机相关并发症和临床相关的HAI。第二个目标是调查影响危重成人刷牙频率、收益和风险的患者因素。这些目标将使用前瞻性、随机化、实验设计来实现。受试者(n=345)将在插管后24小时内被随机分配到三个由研究人员刷牙频率不同的干预组(每天一次、两次或三次)。在干预期间，将每天评估牙菌斑(UM-OHI评分，通过使用数码口腔内相机记录和增强观察)、粘膜炎症(牙龈沟液IL-1β)和HAI。数据分析将侧重于提供明确的 通过联合评价非劣势(牙菌斑比较)指导临床实践 组间通过协方差分析)和伤害所需数量的量化。重复测量线性混合模型(将牙菌斑和粘膜炎症作为独立的结果变量)将提供对特定患者水平因素的洞察，这些因素可能改变与刷牙频率相关的临床有效性和安全性。关于每种刷牙频率的有效性和安全性的信息将为最佳刷牙频率提供明确的建议，并直接转化为临床实践。

DESCRIPTION (provided by applicant): Despite its prominent position in bedside care, there is little evidence to judge the benefits or associated risks of nurse-administered tooth brushing for mechanically ventilated adults, and the optimal frequency of tooth brushing in the critically il has never been experimentally determined. This project will complete the examination of oral care interventions in mechanically ventilated adults with a randomized clinical trial of tooth brushing frequency (once, twice, or three times daily) focused on conclusively defining the benefit and risk of varied frequencies, and identification of moderating patient-level factors for risk and benefit. The project's overall goal is to determine optimal tooth brushing frequency for mechanically ventilated adults. Optimal tooth brushing frequency is important for control of dental plaque and reduction of oral inflammation; it is likely to improve patient comfort, improve efficiency of nursing care, and may reduce systemic sequellae related to oral inflammation. The primary aims of the proposed project are: 1) Evaluate the clinical equivalence (non- inferiority) o three tooth brushing frequencies on oral health (dental plaque and mucosal inflammation) in critically ill adults receiving mechanical ventilation; and 2) Quantify and compare the safety of three tooth brushing frequencies on serious adverse outcomes, including ventilator associated complications and clinically relevant HAIs. A secondary aim is to investigate patient factors that influence tooth brushing frequency benefit and risk in critically ill adults. These objectives willbe accomplished using a prospective, randomized, experimental design. Subjects (n=345) will be randomly assigned within 24 hours of intubation to one of three intervention groups which differ in frequency of tooth brushing delivered by study personnel (once, twice, or three times daily). Dental plaque (UM-OHI score, with observations documented and augmented by use of a digital intraoral camera), mucosal inflammation (gingival crevicular fluid IL-1β), and HAIs will be assessed daily during the intervention period. The data analysis will focus on providing definitive clinical practice guidance through joint evaluation of non-inferiority (comparison of dental plaque between groups by analysis of covariance) and quantification of number needed to harm. Repeated measures linear mixed models (treating dental plaque and mucosal inflammation as separate outcome variables) will provide insight as to specific patient-level factors that may modify the clinical effectiveness and safety profile associated with frequency of tooth brushing. Information about efficacy and safety of each frequency of tooth brushing will provide a clear recommendation for optimal tooth brushing frequency with direct translation to clinical practice.