Detecting Aspiration Associated with Tube Feedings

描述（由申请方提供）：拟议研究的总体目标是改善危重机械通气（MV）管饲患者的结局。更具体地说，这项研究旨在确定在何种程度上修改选定的危险因素吸入可以减少这种潜在的致命并发症管喂养。经常误吸尤其危险，因为它大大增加了患肺炎的可能性。可改变的误吸风险因素包括进食部位、插管位置、患者体位和胃残留量（GRV）。在拟议研究中测试的所有干预措施都可能易于执行;然而，尚未前瞻性地测试它们在减少误吸方面的集体有效性。这项研究符合NTNR的使命，即降低各种个体（包括危重患者）的不良呼吸结局风险。将采用两组准实验设计，比较294例接受住院治疗的重症MV管饲患者（2002-2004年队列）的结局（误吸频率和肺炎发生率）与214例接受拟定误吸风险降低方案（ARRP）的重症MV管饲患者的相同结局。次要目的是描述ARRP减少医院资源使用的程度。数据收集将在16个月内在三个与先前研究相同的重症监护病房进行。ARRP由四项干预措施组成：（1）当胃动力显著减慢时，由床边护士将饲管置入小肠;（2）检测并更换错位的饲管;（3）将床头抬高至至少30度角，除非有禁忌症;（4）检测并管理高胃残留量（GRV）。一名在重症监护护理和鼻肠管放置方面具有高级技能的临床护理专家（CNS）每周将提供40小时的培训，以教育和指导三个ICU中的护理人员关于ARRP。ARRP中包括用于测试饲管放置和管理高GRV的算法。主要结局指标为胃内容物吸入（根据吸入的气管分泌物中是否存在胃蛋白酶定义）和肺炎（根据简化的临床肺部感染评分等于或大于6定义）。在研究开始前，将由适当的医院委员会审查ARRP策略，以用于将进行研究的三个ICU中的所有患者。相关ICU的首席护士长和医务主任支持ARRP。将使用独立组的t检验比较产妇护理和ARRP的结局变量。将通过定量和定性方法评估ARRP的交付、接收和颁布。

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.