Strategies for Airway Management & Prevention Endotracheal Tube Cuff Intervention

描述（由申请人提供）：拟议研究的长期目标是降低与呼吸机相关性肺炎（VAP）相关的发病率、死亡率和成本。需要机械通气的重症患者具有VAP的高风险，VAP是一种并发症，其导致（a）在重症监护室和医院的停留时间延长;（B）成本增加;（c）发病率;和（d）死亡率。机械通气通过人工气道，气管内导管（ETT）提供。ETT在远端有一个球囊或套囊，可充气以在气管中形成密封。ETT套囊压力必须保持在最佳范围内，该范围应足够高以确保通气并防止吸入，但又足够低以确保气管壁的灌注。虽然已经建立了最佳ETT袖带压力的指南，但将压力保持在最佳范围内需要监测和注意压力变化。目前的标准治疗是每8至12小时间歇性测量和调整ETT袖带压力。本探索性研究建议实施ETT袖带压力的连续监测，以：1）识别影响ETT袖带压力的临床因素; 2）描述ETT袖带压力的自然历史; 3）测试创新气道管理干预-使用报警器连续监测ETT袖带压力-与标准治疗相比，将ETT袖带压力维持在最佳范围内的有效性。将采用随机交叉设计。受试者（n = 32）年龄≥ 18岁，接受口服ETT，需要机械通气。在对照期间，将持续监测ETT袖带压力（但对研究者设盲），并根据标准治疗进行调整。在干预期间，将持续监测ETT袖带压力，并根据警报触发器将压力调整至最佳水平。在整个控制和干预期间，将记录患者活动和护理干预，以评估对ETT袖带压力的影响。数据分析将包括重复测量分析、函数主成分分析和函数方差分析。我们的假设是，临床因素将影响ETT袖带压力，压力将随着时间的推移而降低，并且在维持最佳袖带压力方面，新型干预将比标准治疗更有效。改善气管插管的管理可以降低危重患者呼吸机相关性肺炎的风险及其相关的发病率和死亡率。研究结果将有助于设计气道管理干预措施和技术，以改善危重患者的预后，并为制定干预/技术包以减少VAP提供信息。

DESCRIPTION (provided by applicant): The long-term goal of the proposed research is to reduce morbidity, mortality, and costs associated with ventilator-associated pneumonia (VAP). Critically ill patients who require mechanical ventilation are at high risk for VAP, a complication that results in (a) prolonged lengths of stay in the intensive care unit and hospital; (b) increased costs; (c) morbidity; and (d) mortality. Mechanical ventilation is provided via an artificial airway, the endotracheal tube (ETT). The ETT has a balloon or cuff at the distal end that is inflated to create a seal in the trachea. The ETT cuff pressure must be maintained within an optimal range that is high enough to ensure ventilation and prevent aspiration, yet low enough to ensure perfusion of the tracheal wall. While guidelines for optimal ETT cuff pressure have been established, maintaining pressure within an optimal range requires monitoring and attention to pressure variation. The current standard of care is intermittent measurement and adjustment of ETT cuff pressures every 8 to12 hours. This exploratory study proposes implementation of continuous monitoring of ETT cuff pressures to: 1) Identify clinical factors that influence ETT cuff pressures; 2) describe the natural history of ETT cuff pressures; and 3) test the effectiveness of an innovative airway management intervention-continuous monitoring of ETT cuff pressures with alarm triggers-versus the standard of care, on maintaining ETT cuff pressures within an optimal range. A randomized crossover design will be used. Subjects (n = 32) will be age 18 or older, have an oral ETT, and require mechanical ventilation. During the control period, ETT cuff pressures will be monitored continuously (but blinded to the investigators), and adjusted according to the standard of care. During the intervention, ETT cuff pressures will be continuously monitored, and pressures will be adjusted to optimal levels based on alarm triggers. Throughout both control and intervention periods, patient activities and nursing interventions will be recorded to assess effects on ETT cuff pressures. Data analysis will include repeated measures analysis, functional principal component analysis, and functional analysis of variance. Our hypotheses are that clinical factors will affect ETT cuff pressures, pressures will decrease over time, and that the novel intervention will be more effective than the standard of care in maintaining optimal cuff pressures. Improved management of the endotracheal tube may reduce the risk of ventilator associated pneumonia in critically ill patients and its associated morbidity and mortality. Findings will assist in designing airway management interventions and technologies to improve the outcomes of critically ill patients, and inform the development of an intervention/technology package to reduce VAP.