Endoscopic Evaluation of Swallowing in Healthy Participants Across the Lifespan

描述（由申请人提供）：自大约1988年以来，已提供了灵活的吞咽内镜评价（FEES），以评估患者的吞咽功能并确定适当的口服摄入量。在这个阶段，FEES不是一种新的诊断工具;然而，新的是我们在健康参与者中评估的吞咽试验数据的发现。令人惊讶的是，缺乏关于“正常吞咽”的数据来指导医疗保健提供者确定什么是“异常吞咽”。“在我们的试点研究中，我们发现了一个意想不到的广泛的正常吞咽，以前没有报告或目前赞赏。也就是说，我们在65名健康的老年参与者中发现，吞咽比预期的慢，食物和液体残留在他们的喉咙中，并且发生误吸（即，食物或液体进入声带水平以下的气道）。具体来说，在后一项观察中，我们发现19%的老年人在试点研究期间的某个时间点表现出误吸。因此，该项目的主要目的是通过FEES检查正常参与者在整个生命周期中的吞咽，以提供正常的准确定义，作为临床和研究领域异常吞咽诊断的基准。具体目标一是评估年龄、性别、推注类型、推注体积、推注粘度和推注输送方法对健康参与者吞咽的影响。吞咽将采用4个指标进行评估：1）穿透抽吸量表（PAS）评分，2）咽部反应持续时间，3）咽部闭合持续时间，4）FEES期间的咽部残留物。20-90岁的210人将参加。我们的试验数据支持以下假设：在老年人中观察到更多的穿透和抽吸事件、更长的咽部反应、更长的咽部闭合持续时间和更大的残留。男性的咽闭合持续时间长于女性。大剂量时，穿透和抽吸发生率更高，咽部反应时间更长，咽部残留物更多。穿透和抽吸事件/评分受推注类型的影响（例如，牛奶对水）和粘度（例如，稀的液体对浆）。提出了四个实验，以进一步研究这些初步发现的细节。具体目标二是确定四个吞咽参数的评价者内和评价者间信度。将根据初始和短期（即，一天）和长期（即，一周）重复评级。评估者间可靠性将作为来自相等平衡组的9名临床医生的临床医生内窥镜经验的函数获得（即，初级、中级和高级=分别执行10-100、101- 1，000和1，001 - 10，000 FEES）。完成这两个目标将提供关于正常参与者吞咽的可靠的初步数据，并通过FEES评估其可靠性。这项探索性R 03试点资助的结果将指导R 01资助平台的分层需求，该平台将获得关于FEES吞咽的广泛规范性数据。 相关性：该项目的主要目的是通过吞咽的柔性内窥镜评估（FEES）检查健康参与者的吞咽。目前，临床医生和研究人员几乎没有关于正常吞咽的数据来准确诊断吞咽障碍并提出适当的饮食建议。从这项研究中获得的信息不仅将大大提高吞咽障碍患者的诊断和临床护理，而且还将作为建立R 01赠款申请的正常吞咽的基础数据。

DESCRIPTION (provided by applicant): Flexible endoscopic evaluation of swallowing (FEES) has been available, since approximately 1988, to assess patient swallowing function and determine appropriate oral intake. At this stage, FEES is not a novel diagnostic tool; however, what is novel are the findings from our pilot data on swallowing as assessed in healthy participants. Surprisingly, scant data exist on "normal swallowing" to guide health care providers in determining what constitutes "abnormal swallowing." In our pilot studies, we found an unexpectedly broad range of normal swallowing that has not been previously reported or currently appreciated. That is, we found in 65 healthy older adult participants, slower swallowing than expected, food and liquid residue in their throats, and occurrences of aspiration (i.e., food or liquid enters the airway below the level of the vocal folds). Specifically, on the latter observation, we found that 19% of our older adults demonstrated aspiration at some point and time during the pilot studies. Accordingly, the primary aim of this project is to examine swallowing, via FEES, in normal participants across the life span in an effort to provide an accurate definition of normal to serve as a benchmark for the diagnoses of abnormal swallowing in both clinical and research realms. Specific aim one is to assess the effect of age, gender, bolus type, bolus volume, bolus viscosity, and bolus delivery method on swallowing in healthy participants. Swallowing will be assessed with four indices: 1) penetration aspiration scale (PAS) scores, 2) pharyngeal response duration, 3) pharyngeal closure duration, and 4) pharyngeal residue during FEES. Two hundred ten individuals, 20-90 years old will participate. Our pilot data support the following hypotheses: More penetration and aspiration events, longer pharyngeal response, longer pharyngeal closure duration, and greater residue are observed in older adults. Pharyngeal closure duration is longer in males than in females. Penetration and aspiration occurrences are greater, pharyngeal response times are longer, and pharyngeal residue is greater with larger boluses. Penetration and aspiration events/scores are affected by bolus type (e.g., milk vs. water) and viscosity (e.g., thin liquid vs. puree). Four experiments are proposed to further investigate these preliminary findings in detail. Specific aim two is to determine the intra-and inter-rater reliability of the four swallowing parameters. Intra-rater reliability will be tabulated from nine clinicians as a function of initial, and short- (i.e., one day) and long-term (i.e., one-week) repeat ratings. Inter-rater reliability will be acquired as a function of clinician endoscopic experience from nine clinicians of equal balanced groups (i.e., beginning, intermediate, and advanced = 10-100, 101-1,000, and 1,001-10,000 FEES performed, respectively). Completing these two aims will provide robust preliminary data on swallowing in normal participants and its reliability as assessed with FEES. The results of this exploratory R03 pilot grant will guide the stratification needs of a R01 grant platform that will obtain extensive normative data on swallowing with FEES. Relevance: The primary aim of this project is to examine swallowing, via Flexible Endoscopic Evaluation of Swallowing (FEES), in healthy participants across the life span. Currently, there is surprisingly little data on normal swallowing for clinicians and researchers to accurately diagnose swallowing disorders and make appropriate diet recommendations. The information derived from this study will not only serve to greatly enhance diagnosis and clinical care of patients with swallowing disorders but also serve as foundational data on normal swallowing of which to build a R01 grant application.