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来改善外周和中枢前庭疾病的临床护理。眩晕和头晕导致每年400万次美国急诊科（艾德）就诊，花费40亿美元。大约100万外周前庭原因导致其症状的患者中，大多数都是过度测试，误诊和治疗不足。数亿美元用于神经影像学（约5亿美元CT，约1亿美元MRI），试图检测约5%的患者，这些患者患有危及生命的后颅窝中风，导致他们的眩晕-但这些前庭中风中有三分之一被遗漏。准确、高效的诊断将通过及时、适当的治疗来挽救生命并降低成本。我们的团队已经研究了艾德的头晕超过十年。我们已经开发出一种新的方法来区分良性的周边原因从危险的中央仔细评估前庭眼球运动（HINTS：头脉冲，眼球震颤，测试的倾斜）和听力。我们的方法能够在床旁进行快速的生理诊断，在急性持续性眩晕或头晕发作后的头两天内，其准确性高于MRI脑部扫描。该方法已在200多名患者中得到验证。类似的，完善的床边技术（例如，Dix-Hallpike试验）可用于诊断间歇性体位性眩晕。不幸的是，大多数艾德医生，甚至许多专家都不熟悉这些眼动测试。一种新的视频眼电图（VOG）设备，测量这些眼动定量在床边有可能改变诊断艾德患者头晕和眩晕。该设备易于使用，测量眼球运动准确，不需要更多的病人合作比床边检查颅神经。我们已经初步证明该设备可以正确诊断急性前庭中风。我们提出了AVERT试验（急诊室快速分诊的急性视频眼电图检查），这是一项多中心、随机、II期临床试验，旨在比较VOG引导与标准治疗，以改善主要症状为眩晕或疑似前庭原因所致头晕患者的诊断和初始管理。我们将从3个ED招募226名成人。我们将对所有受试者进行床旁VOG和便携式测听，然后将其随机分配至VOG指导与标准治疗组。在VOG组中，患者将根据VOG结果指导的标准、预定义方案，使用自动化、循证决策规则进行诊断和治疗。我们将比较这种VOG引导的护理路径相对于标准护理对艾德诊断、诊断资源利用、诊断成本、应用的治疗和短期结局的影响。我们假设，在艾德中，VOG引导的急性眩晕或头晕的诊断和管理将（1）提高诊断的准确性，并增加对前庭疾病的正确治疗，（2）降低诊断成本，（3）提供 改善患者健康结果的潜力。这项研究的结果可以改变数百万艾德眩晕患者的护理，为目前的做法提供更高质量，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.