跳至主要内容
临床试验/NCT02782962
NCT02782962已完成不适用

Accuracy of a Diagnostic Algorithm for the Differential Diagnosis of Vertigo in the Emergency Department: the STANDING.

Azienda Ospedaliero-Universitaria Careggi1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2014年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
350
试验地点
1
主要终点
acute brain injury

研究概览

简要总结

This study evaluate the diagnostic accuracy of a simplified clinical algorithm (STANDING) for the differential diagnosis of acute vertigo in the emergency department.

In particular, the investigators want to analyze the sensitivity and specificity of the test for the diagnosis of vertigo of central origin and the reproducibility of the test.

In suspected central vertigo of ischemic origin, a duplex sonography to identify vertebral artery pathology will be performed.

详细描述

The STANDING test is a structured diagnostic algorithm based on previously described diagnostic signs or bedside maneuvers, the investigators have logically assembled in four sequential steps.

  1. Assessment of nystagmus presence (spontaneous vs positional) 2) Assessment of nystagmus direction 3) Head Impulse Test (HIT) 4) Standing (SponTaneous, Direction, hIt, standiNG: STANDING)
  1. First, the presence of nystagmus will be assessed with Frenzel goggles in a supine position after at least five minutes of rest. When no spontaneous nystagmus is present in the main gaze positions, the presence of a positional nystagmus will be assessed by the Pagnini test first and then by the Dix-Hallpike test (5). The presence of a positional, transient nystagmus will be considered typical of BPPV.
  2. Instead, when spontaneous nystagmus is present, the direction will be examined: multidirectional nystagmus, such as bidirectional gaze-evoked nystagmus (ie, right beating nystagmus present with gaze toward the right and left beating nystagmus present with gaze toward the left side), and a vertical (up or down beating) nystagmus will be considered signs of central vertigo (Video 3).
  3. When the nystagmus is unidirectional (ie, nystagmus beating on the same side independent of the gaze direction) we will performed the Head Impulse Test (HIT)(13). When an acute lesion occurs on one labyrinth, the input from the opposite side is unopposed and as a result, when the head is rapidly moved toward the affected side, the eyes will be initially pushed toward that side and, immediately after, a corrective eye movement (corrective "saccade") back to the point of reference is seen. When the corrective "saccade" is present the HIT is considered positive and it indicates non-central AV, whereas a negative HIT indicates central vertigo(14).
  4. Patients showing neither spontaneous nor positional nystagmus were invited to stand and gait was evaluated. When objective imbalance was present they were suspected to have central disease.

STANDING will be performed before imaging test. STANDING results will be unknown to the attending emergency physician and to the panel of experts who will establish the final diagnosis at the end of follow-up of three months. The physician who will perform the STANDING will not know patient's clinical data, except those detectable during the STANDING test.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with acute vertigo/unsteadiness

排除标准

  • Patients unable to collaborate (patients with severe dementia, bedridden patient)
  • Patients unable to follow-up (3 months)
  • Patients with terminal disease (3 supposed months of survival)
  • Patients with known cervical spine and neck diseases to whom positioning may be dangerous.
  • Patients who refuse to participate the study
  • Patients with pseudo-vertigo

结局指标

主要结局

acute brain injury

时间窗: 3 months

The reference standard (central vertigo) was a composite of acute brain injury at initial head imaging or a diagnosis of stroke, demyelinating disease, neoplasm or other acute brain disease during 3 months follow-up

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Peiman Nazerian

MD

Azienda Ospedaliero-Universitaria Careggi

研究点 (1)

Loading locations...

相似试验