Oral Care Intervention in Mechanically Ventilated Adults

描述（由申请人提供）：尽管其在床边护理中的突出地位，但几乎没有证据可以判断护士管理的刷牙对机械通气成人的益处或相关风险，并且从未通过实验确定危重患者的最佳刷牙频率。该项目将完成对机械通气成人口腔护理干预的检查，并对刷牙频率（每天一次、两次或三次）进行随机临床试验，重点是最终确定不同频率的获益和风险，并确定风险和获益的患者水平调节因素。该项目的总体目标是确定机械通气成人的最佳刷牙频率。最佳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。该项目的主要目的是：1）评价三种刷牙频率对接受机械通气的重症成人口腔健康（牙菌斑和粘膜炎症）的临床等效性（非劣效性）; 2）量化并比较三种刷牙频率对严重不良结局的安全性，包括呼吸机相关并发症和临床相关HAI。第二个目的是研究影响重症成人刷牙频率的患者因素。这些目标将通过前瞻性、随机化、实验设计来实现。受试者（n=345）将在插管后24小时内被随机分配至三个干预组之一，这三个干预组的研究人员刷牙频率不同（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，记录观察结果并通过使用数字口内相机进行增强）、粘膜炎症（龈沟液IL-1β）和HAI。数据分析将侧重于提供明确的 通过非劣效性联合评价指导临床实践（牙菌斑比较 组间的协方差分析）和所需伤害数量的量化。重复测量线性混合模型（将牙菌斑和粘膜炎症作为单独的结局变量处理）将提供关于可能改变与刷牙频率相关的临床有效性和安全性特征的特定患者水平因素的见解。关于每种刷牙频率的有效性和安全性的信息将为直接转化为临床实践的最佳刷牙频率提供明确的建议。

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.