Accuracy of a Diagnostic Algorithm for the Differential Diagnosis of Vertigo in the ED: the STANDING. (STANDING)

June 6, 2016 updated by: Peiman Nazerian, Azienda Ospedaliero-Universitaria Careggi

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Tuscany
      • Firenze, Tuscany, Italy, 50134
        • Emergency Department Azienda Ospedaliera Universitaria Careggi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Consecutive adult patients presenting to the ED of the University Hospital Careggi (AOUC) for vertigo/unsteadiness

Description

Inclusion Criteria:

  • Patients with acute vertigo/unsteadiness

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cohort
Patients with acute vertigo/unsteadiness

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute brain injury
Time Frame: 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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria Careggi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

May 23, 2016

First Submitted That Met QC Criteria

May 23, 2016

First Posted (Estimate)

May 26, 2016

Study Record Updates

Last Update Posted (Estimate)

June 8, 2016

Last Update Submitted That Met QC Criteria

June 6, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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