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

描述（由申请人提供）：本研究旨在通过将前庭生理学的最新进展转化为临床实践，改善周围和中枢前庭疾病的临床护理。眩晕和头晕每年导致美国急诊科400万人次就诊，造成40亿美元的损失。大约100万的前庭外周病因患者中，大多数被过度检测、误诊和治疗不足。在神经成像上花费了数亿美元（约5亿美元的CT，约1亿美元的MRI），试图检测出约5%的危及生命的后窝中风患者，这些患者导致了眩晕——然而三分之一的前庭中风被遗漏了。准确和有效的诊断将通过及时和适当的治疗挽救生命并降低费用。我们的团队研究急诊科的头晕已有十多年了。我们开发了一种新的方法，通过仔细评估三种前庭眼运动（提示：头部冲动、眼球震颤、斜视试验）和听力来区分良性外周原因和危险的中枢原因。我们的方法能够在急性持续性眩晕或头晕发作后的头两天内，在床边快速进行生理诊断，比MRI脑部扫描更准确。这种方法已经在200多名患者身上得到了验证。类似的，成熟的床边技术（如Dix-Hallpike试验）可用于诊断间歇性体位性眩晕。不幸的是，大多数急诊科医生甚至许多专科医生都不熟悉这些眼动测试。一种新的视频眼摄影（VOG）设备可以在床边定量测量这些眼球运动，有可能改变ED患者头晕和眩晕的诊断。该设备易于使用，能准确测量眼球运动，只需对脑神经进行床边检查，无需患者配合。我们已经初步证明该设备能正确诊断急性前庭中风。我们建议进行AVERT试验（用于快速分诊的急诊室眩晕急性视频视觉摄影），这是一项多中心、随机、vog引导与标准治疗的II期临床试验，旨在改善以眩晕或怀疑是前庭原因引起的头晕为主要症状的患者的诊断和初始管理。我们将从3个ed中招募226名成年人。我们将对所有受试者进行床边VOG和便携式听力测量，然后将他们随机分为VOG引导组和标准治疗组。在VOG组，患者将根据VOG结果指导的标准、预定义的方案，使用自动的、基于证据的决策规则进行诊断和治疗。我们将比较这种vog引导的护理途径相对于标准护理在ED诊断、诊断资源利用、诊断成本、治疗应用和短期结果方面的影响。我们假设vog引导的急诊科急性眩晕或头晕的诊断和管理将(1)提高诊断准确性，增加对前庭疾病的正确治疗，(2)降低诊断成本，(3)提供更有效的治疗方法

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.