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

AVERT_急诊室眩晕的急性视频眼科检查以进行快速分类

基本信息

批准号：
8928136
负责人：
DAVID NEWMAN-TOKER
金额：
$ 112.2万
依托单位：
JOHNS HOPKINS UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2014
资助国家：
美国
起止时间：
2014-09-16 至 2019-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8928136
关键词：
Accident and Emergency department Acute Adherence Admission activity Adult Adverse event Aftercare Audiometry Benign Benign paroxysmal positional vertigo Brain Stem Brain imaging Brain scan Caring Clinical Clinical Data Clinical Trials Clinical Trials Design Consult Consultations Cost Analysis Cranial Nerves Data Devices Diagnosis Diagnostic Diagnostic tests Disease Dizziness Eligibility Determination Emergency Care Emergency Department Physician Emergency Department patient Emergency department visit Event Eye Eye Movements FDA approved Failure Financial compensation Frequencies Gold Guidelines Head Health Health Information National Trends Survey Hearing Home environment Hospitals Image Labyrinth Lead Length of Stay Lesion Life Magnetic Resonance Imaging Masks Measures Neurology Ophthalmic examination and evaluation Otolaryngology Outcome Outcome Study Pathologic Pathologic Nystagmus Pathway interactions Patients Performance Peripheral Phase Phase II Clinical Trials Physicians Physiological Physiology Positioning Attribute Posterior Fossa Protocols documentation Public Health Quality of Care Randomized Recruitment Activity Relative (related person)Research Personnel Resources Safety Serious Adverse Event Site Solutions Specialist Stroke Structure Symptoms Techniques Testing Time Training Translating Triage Vertigo Vestibular Neuronitis Visit Visual Work accurate diagnosis adjudicate arm base clinical care clinical practice compliance behavior cost design diagnostic accuracy equilibration disorder evidence base falls follow-up functional outcomes improved indexing inner ear diseases multidisciplinary neuroimaging novel strategies oculomotor phase II trial phase III trial prevent primary outcome randomized trial rapid diagnosis research study secondary outcome standard care systematic review tool trial comparing vestibulo-ocular reflex

项目摘要

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.

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，以改善外围和中央前庭疾病的临床护理。 Vertigo和Dizziness每年以40亿美元的价格访问美国急诊室（ED）400万。大多数约有100万患有前庭症状的病因的患者过度测试，误诊和治疗不足。数亿美元用于神经影像学上（约5亿美元CT，约1亿美元MRI），试图检测约5％的患者危及生命的后窝中风的患者，导致其眩晕，但其中有三分之一却错过了这些前庭中风。准确有效的诊断将通过迅速而适当的治疗来挽救生命并降低成本。我们的团队在急诊室学习了十多年的头晕。我们已经开发了一种新的方法，通过仔细评估三种前庭眼动运动（提示：头部冲动，眼球震颤，偏斜测试）和听力，将良性的外围原因与危险的中心原因区分开。在急性，连续的眩晕或头晕发作后的前两天，我们的方法可以在床边快速生理诊断，其精度比MRI脑扫描更高。该方法已在200多名患者中得到了验证。类似的，建立的床边技术（例如，Dix-Hallpike测试）可诊断间歇性，发动的眩晕。不幸的是，这些眼动测试对大多数ED医生甚至许多专家都不熟悉。一种在床边定量测量这些眼动的新视频摄影（VOG）设备有可能改变头晕和眩晕患者的ED诊断。该设备易于使用，准确地测量眼睛运动，并且不需要比颅神经的床边检查更多的患者合作。我们已经显示了该设备正确诊断急性前庭中风的初始证据。我们提出了Avert试验（急诊室中眩晕的急性视频记录术，用于快速分类），这是一项多中心，随机，II期临床试验的VOG引导与标准护理的临床试验，以改善眩晕性或头晕目的的主要症状的诊断和初始治疗。我们将从3 eds招募226名成年人。我们将对所有受试者进行床头VOG和便携式听力测定法，然后将其随机分为VOG引导与标准护理。在VOG部门中，将根据标准的预定义方案对患者进行诊断和治疗，该方案以VOG结果为指导，使用自动证据，基于证据的决策规则。我们将比较此VOG指导的护理途径相对于标准护理对ED诊断，诊断资源利用，诊断成本，应用治疗和短期结果的影响。我们假设ED中急性眩晕或头晕的VOG引导的诊断和管理（1）提高诊断准确性并增加了前庭疾病的正确治疗方法，（2）降低诊断成本，（3）提供（3）改善患者健康结果的潜力。这项研究的结果可能会改变数百万ED患有眩晕患者的护理，从而提供了当前实践的更高质量，更低的替代品。