Detecting Aspiration Associated with Tube Feedings

描述（由申请人提供）：拟议研究的总体目的是改善危重症机械通气（MV）管饲患者的预后。更具体地说，该研究旨在确定在何种程度上修改选定的危险因素的误吸可以减少这种潜在的致命并发症的管饲。频繁的误吸尤其危险，因为它大大增加了患肺炎的可能性。可改变的误吸危险因素包括喂食部位、管位、患者体位和胃残量（GRV）。在拟议的研究中测试的所有干预措施都可能很容易执行；然而，它们在减少渴望方面的集体功效尚未得到前瞻性的检验。拟议的研究与NTNR的使命是一致的，即降低各种个体（包括危重患者）发生不良呼吸后果的风险。采用两组准实验设计比较294例接受常规护理（2002-2004队列）的危重MV管饲患者与214例接受拟议的误吸风险降低方案（ARRP）的危重MV管饲患者的结果（误吸频率和肺炎发生率）。第二个目标是描述ARRP减少医院资源使用的程度。数据收集将在前一项研究进行的三个重症监护室进行，为期16个月。ARRP包括四项干预措施：(1)当胃运动明显减慢时，床边护士将饲管置入小肠；(2)检测并更换定位不正确的饲管；(3)除非有禁忌，否则将床头抬高至至少30度角；(4)检测和处理高胃残留量（GRVs）。临床护理专家（CNS）在重症监护护理和鼻肠管放置方面具有先进的技能，每周将有40小时的时间来教育和指导三个icu的护理人员关于ARRP。测试饲管放置和管理高grv的算法包括在ARRP中。主要结局指标为胃内容物误吸（由吸入的气管分泌物中是否存在胃蛋白酶来定义）和肺炎（由简化的临床肺部感染评分等于或大于6来定义）。在研究开始之前，ARRP策略将由适当的医院委员会进行审查，以便在进行研究的三个icu的所有患者中使用。有关icu的护士长和医务主任都支持ARRP。将使用独立组的t检验来比较常规护理和ARRP在结果变量上的差异。ARRP的交付、接收和颁布将通过定量和定性方法进行评估。

DESCRIPTION (provided by applicant): The overall aim of the proposed study is to improve outcomes in critically ill, mechanically ventilated (MV) tube-fed patients. More specifically, the study seeks to determine the extent to which modification of selected risk factors for aspiration can reduce this potentially lethal complication of tube feedings. Frequent aspiration is especially dangerous in that it greatly increases the probability of pneumonia. Modifiable risk factors for aspiration include feeding site, tube position, patient position, and gastric residual volume (GRV). All of the interventions to be tested in the proposed study are potentially easy to perform; however, their collective efficacy in reducing aspiration has not been tested prospectively. The proposed study is consistent with the NTNR's mission to reduce risk for adverse respiratory outcomes in a variety of individuals, including those who are critically ill. A two-group quasi-experimental design will be employed to compare outcomes (frequency of aspiration and incidence of pneumonia) in 294 critically ill MV tube-fed patients who received Usual Care (2002-2004 cohort) to the same outcomes in 214 critically ill MV tube-fed patients who will receive the proposed Aspiration Risk Reduction Protocol (ARRP). A secondary objective is to describe the extent to which the ARRP decreases use of hospital resources. Data collection will take place over a period of 16 months in three of the same intensive care units where the previous study took place. The ARRP is composed of four interventions: (1) placement of feeding tubes by bedside nurses into the small-bowel when gastric motility is significantly slowed, (2) detection and replacement of malpositioned feeding tubes, (3) elevation of the head-of-bed to at least a 30 degree angle, unless contraindicated and (4) detection and management of high gastric residual volumes (GRVs). A Clinical Nurse Specialist (CNS) with advanced skills in critical care nursing and placement of nasoenteral tubes will be available 40 hours per week to educate and coach caregivers in the three ICUs regarding the ARRP. Algorithms for testing feeding tube placement and for managing high GRVs are included in the ARRP. The primary outcome measures are aspiration of gastric contents (as defined by the presence of pepsin in suctioned tracheal secretions) and pneumonia (as defined by a simplified Clinical Pulmonary Infection Score equal to or greater than 6). Prior to initiation of the study, the ARRP strategies will be reviewed by the appropriate hospital committees for use in all patients in the three ICUs where the study will take place. The Chief Nursing Officer and Medical Directors of the involved ICUs are supportive of the ARRP. A t-test for independent groups will be used to compare Usual Care and ARRP on the outcome variables. Delivery, receipt and enactment of the ARRP will be evaluated by quantitative and qualitative methods.