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，但很少有证据来判断护士管理的机械通气成人刷牙的益处或相关风险，并且在危重病人中刷牙的最佳频率从未实验确定过。本项目将通过一项随机临床试验来完成对机械通气成人口腔护理干预措施的检查，该试验的重点是最终确定不同频率刷牙的益处和风险，并确定患者层面的风险和益处调节因素。该项目的总体目标是确定机械通气成人的最佳刷牙频率。最佳的刷牙频率对控制牙菌斑和减少口腔炎症很重要；这可能会提高患者的舒适度，提高护理效率，并可能减少与口腔炎症相关的全身后遗症。拟建项目的主要目的是：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的HAIs。第二个目的是调查影响重症成人刷牙频率的益处和风险的患者因素。这些目标将通过前瞻性、随机化的实验设计来实现。受试者（n=345）将在插管后24小时内被随机分配到三个干预组中的一个，干预组由研究人员提供的刷牙频率不同（每天一次、两次或三次）。在干预期间，每天评估牙菌斑（UM-OHI评分，使用数字口内相机记录和增强观察结果）、粘膜炎症（龈沟液IL-1β）和HAIs。数据分析将侧重于提供确定性

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.