AVERT_Acute Video-oculography for Vertigo in Emergency Rooms for Rapid Triage

描述(申请人提供)：这项研究旨在通过将前庭生理学的最新进展转化为临床实践来改善外周和中枢性前庭疾病的临床护理。眩晕和眩晕每年导致美国急诊科就诊400万人次，花费40亿美元。在大约100万名因症状而导致前庭周围性疾病的患者中，大多数被过度检测、误诊和治疗不足。数亿美元花在神经成像上(~5亿美元的CT，~1亿美元的MRI)，试图检测出~5%的患者患有危及生命的后颅窝中风导致眩晕-但三分之一的前庭中风被遗漏。准确、高效的诊断将通过及时和适当的治疗拯救生命和降低成本。我们的团队在ED中研究头晕已经有十多年了。我们开发了一种新的方法来区分良性外周原因和危险的中枢性原因，通过仔细评估三种前庭眼球运动(暗示：头部冲动、眼球震颤、斜视测试)和听力。在急性、持续性眩晕或眩晕发作后的头两天，我们的方法能够在床边进行快速生理诊断，比MRI脑扫描具有更高的准确性。这种方法已经在200多名患者中得到了验证。类似的、成熟的床边技术(例如，Dix-Hallpike试验)可用于诊断间歇性、体位性眩晕。不幸的是，这些眼动测试对大多数急诊科医生，甚至许多专家来说都是陌生的。一种新的视频眼科造影术(VOG)设备可以在床边定量测量这些眼球运动，有可能改变对患有头晕和眩晕的ED患者的诊断。该设备易于使用，准确测量眼球运动，不需要更多的患者合作，就像床边的脑神经检查一样。我们已经展示了该设备正确诊断急性前庭中风的初步证据。我们提出了AVERT试验(急诊室中用于快速分诊的眩晕的急性视频眼科造影术)，这是一项多中心、随机的第二阶段临床试验，由VOG指导与标准护理进行比较，以改善主要症状为眩晕或眩晕的患者的诊断和初步治疗，这些患者被怀疑是前庭原因。我们将从3个急救队中招募226名成年人。我们将对所有受试者进行床边VOG和便携式听力测试，然后将他们随机分为VOG指导组和标准组。在VOG ARM中，患者将根据标准的、预定义的方案进行诊断和治疗，该方案以VOG结果为指导，使用基于证据的自动化决策规则。我们将比较这种VOG引导的护理路径相对于标准护理在急诊诊断、诊断资源利用、诊断成本、应用的治疗和短期结果方面的影响。我们假设，VOG引导下的急性期眩晕或眩晕的诊断和治疗将：(1)提高诊断的准确性，增加前庭疾病的正确治疗；(2)降低诊断成本；(3)提供 有可能改善患者的健康状况。这项研究的结果可能会改变数百万患有眩晕的ED患者的护理，为目前的做法提供一种更高质量、更低成本的替代方案。

DESCRIPTION (provided by applicant): This study seeks to improve clinical care for peripheral and central vestibular disorders by translating recent advances in vestibular physiology to clinical practice. Vertigo and dizziness lead to 4 million US emergency department (ED) visits annually at a cost of $4 billion. Most of the ~1 million patients with peripheral vestibular causes for their symptoms are over-tested, misdiagnosed, and undertreated. Hundreds of millions of dollars are spent on neuroimaging (~$500M CT, ~$100M MRI) trying to detect the ~5% of patients who have life-threatening posterior fossa strokes causing their vertigo - yet one-third of these vestibular strokes are missed. Accurate and efficient diagnosis will save lives and reduce costs through prompt and appropriate treatments. Our team has studied dizziness in the ED for more than a decade. We have developed a new approach to differentiate benign peripheral causes from dangerous central ones by careful assessment of three vestibular eye movements (HINTS: Head Impulse, Nystagmus, Test of Skew) and hearing. Our approach enables rapid physiologic diagnosis at the bedside with greater accuracy than MRI brain scans in the first two days after the onset of acute, continuous vertigo or dizziness. This approach has been validated in over 200 patients. Similar, well-established bedside techniques (e.g., Dix-Hallpike test) work to diagnose intermittent, position-provoked vertigo. Unfortunately, these eye movement tests are unfamiliar to most ED physicians, and even to many specialists. A new video-oculography (VOG) device that measures these eye movements quantitatively at the bedside has the potential to transform diagnosis for ED patients with dizziness and vertigo. The device is easy to use, measures eye movements accurately, and requires no more patient cooperation than a bedside exam of the cranial nerves. We have shown initial proof that the device correctly diagnoses acute vestibular strokes. We propose the AVERT trial (Acute Video-oculography for Vertigo in Emergency Rooms for Rapid Triage), a multicenter, randomized, Phase II clinical trial of VOG-guided vs. standard care to improve diagnosis and initial management for patients with a chief symptom of vertigo or dizziness suspected to be of vestibular cause. We will recruit 226 adults from 3 EDs. We will perform bedside VOG and portable audiometry on all subjects, who will then be randomized to VOG-guided vs. standard care. In the VOG arm, patients will be diagnosed and treated according to a standard, predefined protocol guided by VOG results using automated, evidence-based decision rules. We will compare the impact of this VOG-guided care pathway relative to standard care on ED diagnoses, diagnostic resource utilization, costs of diagnosis, treatments applied, and short-term outcomes. We hypothesize that VOG-guided diagnosis and management of acute vertigo or dizziness in the ED will (1) improve diagnostic accuracy and increase correct treatment for vestibular disorders, (2) reduce diagnostic costs, and (3) offer the potential to improve patient health outcomes. Results from this study could transform care for millions of ED patients with vertigo, offering a higher-quality, lower-cost alternative to current practice.