Oral Suction Intervention to Reduce Aspiration and Ventilator Events: NO-ASPIRATE

描述（由申请人提供）：需要机械通气（MV）治疗的重症患者发生并发症的风险增加，导致呼吸机使用时间延长、死亡率高和资源使用增加。通过人工气道（通常为气管内导管（ETT））进行通气。尽管ETT是必要的，但它会增加口腔和口咽部分泌物微吸入肺部的风险。分泌物可能含有口腔细菌或胃内容物继发于反流。因此，微抽吸可导致呼吸机相关疾病（VAC），包括肺损伤和肺炎。几种干预措施，称为“呼吸机束”，已被确定为MV患者的最佳实践，并定期实施。这些有针对性的干预措施减少了感染，但没有解决与VAC发展相关的所有因素。仍然会发生分泌物的微量吸入，增加了伤害的风险。微抽吸开始于口腔和口咽部的分泌物积聚。口腔分泌物的清除不是任何呼吸机束的一部分，该程序既不标准化也没有证据。因此，护理干预，加强口咽吸痰，重点是定期清除这些分泌物超出现有的做法是很重要的。本研究将评估减少误吸和呼吸机事件（无误吸）的口腔抽吸护理方案干预的结局，这是一种标准化的增强口咽抽吸程序，每4小时进行一次。长期目标是改善MV患者的护理，这些患者开始时存在并发症的高风险。本研究的主要目的是评估在预防插管MV患者的微吸入方面，添加无吸入干预是否比常规护理更有效。一项随机、单盲试验设计-招募18岁或以上的危重、通气患者的便利样本（n=560），将在三级护理医院进行口服ETT，以达到400例受试者的目标样本量，这些受试者随机接受无吸入（实验组）或由研究团队成员每4小时递送的常规护理/假干预（常规护理组）。每天采集两次气管和口腔样本，用于分析作为微抽吸生物标志物的？-淀粉酶。VAC将通过疾病控制和预防中心开发的算法进行评估。所有受试者都将接受MV患者的标准护理。数据分析将包括逻辑回归、生存分析和广义估计方程。该研究将提供数据，以制定基于证据的口腔抽吸标准，这是一种护士驱动的干预措施，以防止危重患者的微吸入。

DESCRIPTION (provided by applicant): Critically ill patients who require treatment with mechanical ventilation (MV) are at an increased risk for complications that lead to prolonged days on the ventilator, high mortality, and increased resource use. Ventilation is delivered through an artificial airway, usually an endotracheal tube (ETT). Although essential, the ETT increases the risk of micro aspiration of secretions from the mouth and oropharynx into the lungs. Secretions may contain bacteria from the oral cavity, or gastric contents secondary to reflux. Therefore, micro aspiration can lead to ventilator-associated conditions (VAC), including lung injury and pneumonia. Several interventions, termed a "ventilator bundle," have been identified as best practices for MV patients and are routinely implemented. These targeted interventions have reduced infection, but do not address all factors associated with the development of VAC. Micro aspiration of secretions still occurs, increasing the risk for harm. Micro aspiration starts with accumulation of secretions in the mouth and oropharynx. Removal of oral secretions is not part of any ventilator bundle, and the procedure is neither standardized nor based on evidence. Therefore, a nursing intervention, enhanced oropharyngeal suctioning, that focuses on regular removal of these secretions beyond existing practices is important. This study will assess outcomes of a Nursing Oral Suction Protocol Intervention to Reduce Aspiration and Ventilator-Events (NO-ASPIRATE), a standardized, enhanced oropharyngeal suction procedure delivered every 4 hours. The long-term goal is to improve the care of patients on MV who are at a high risk for complications that begin with micro aspiration of secretions. The primary aim of this study is to assess if the addition of the NO-ASPIRATE intervention will be more effective than usual care in preventing micro aspiration in intubated, MV patients. A randomized, single- blind trial design-enrolling a convenience sample (n=560) of critically-ill, ventilated patients, age 18 years or older, who have an oral ETT-will be conducted at a tertiary care hospital to achieve a target sample size of 400 subjects randomized to receive either the NO-ASPIRATE (experimental group) or a usual care/sham intervention (usual care group) delivered every 4 hours by a study team member. Tracheal and oral specimens for analysis of ¿-amylase as a biomarker for micro aspiration will be obtained twice per day. VAC will be assessed by an algorithm developed by the Centers for Disease Control and Prevention. All subjects will receive the standard of care for MV patients. Data analysis will include logistic regression, survival analysis, and generalized estimating equations. The study will provide data to develop evidence-based standards for oral suction, a nurse-driven intervention, to prevent micro aspiration in critically ill patients.