NCT02782962

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
Last Updated

June 8, 2016

Status Verified

June 1, 2016

Enrollment Period

1.1 years

First QC Date

May 23, 2016

Last Update Submit

June 6, 2016

Conditions

VertigoUnsteadiness

Keywords

nystagmusvertigounsteadinessemergency duplex ultrasonography

Outcome Measures

Primary Outcomes (1)

  • acute brain injury

    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

Study Arms (1)

Cohort

Patients with acute vertigo/unsteadiness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients with acute vertigo/unsteadiness

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emergency Department Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, 50134, Italy

Location

Related Publications (7)

  • Vanni S, Nazerian P, Casati C, Moroni F, Risso M, Ottaviani M, Pecci R, Pepe G, Vannucchi P, Grifoni S. Can emergency physicians accurately and reliably assess acute vertigo in the emergency department? Emerg Med Australas. 2015 Apr;27(2):126-31. doi: 10.1111/1742-6723.12372. Epub 2015 Mar 10.

    PMID: 25756710BACKGROUND

  • Vanni S, Pecci R, Casati C, Moroni F, Risso M, Ottaviani M, Nazerian P, Grifoni S, Vannucchi P. STANDING, a four-step bedside algorithm for differential diagnosis of acute vertigo in the Emergency Department. Acta Otorhinolaryngol Ital. 2014 Dec;34(6):419-26.

    PMID: 25762835BACKGROUND

  • Newman-Toker DE, Kerber KA, Hsieh YH, Pula JH, Omron R, Saber Tehrani AS, Mantokoudis G, Hanley DF, Zee DS, Kattah JC. HINTS outperforms ABCD2 to screen for stroke in acute continuous vertigo and dizziness. Acad Emerg Med. 2013 Oct;20(10):986-96. doi: 10.1111/acem.12223.

    PMID: 24127701BACKGROUND

  • Kerber KA, Brown DL, Lisabeth LD, Smith MA, Morgenstern LB. Stroke among patients with dizziness, vertigo, and imbalance in the emergency department: a population-based study. Stroke. 2006 Oct;37(10):2484-7. doi: 10.1161/01.STR.0000240329.48263.0d. Epub 2006 Aug 31.

    PMID: 16946161BACKGROUND

  • Bisdorff A, Von Brevern M, Lempert T, Newman-Toker DE. Classification of vestibular symptoms: towards an international classification of vestibular disorders. J Vestib Res. 2009;19(1-2):1-13. doi: 10.3233/VES-2009-0343. No abstract available.

    PMID: 19893191BACKGROUND

  • Karatas M. Central vertigo and dizziness: epidemiology, differential diagnosis, and common causes. Neurologist. 2008 Nov;14(6):355-64. doi: 10.1097/NRL.0b013e31817533a3.

    PMID: 19008741BACKGROUND

  • Tarnutzer AA, Berkowitz AL, Robinson KA, Hsieh YH, Newman-Toker DE. Does my dizzy patient have a stroke? A systematic review of bedside diagnosis in acute vestibular syndrome. CMAJ. 2011 Jun 14;183(9):E571-92. doi: 10.1503/cmaj.100174. Epub 2011 May 16. No abstract available.

    PMID: 21576300BACKGROUND

MeSH Terms

Conditions

VertigoNystagmus, Pathologic

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsOcular Motility DisordersCranial Nerve DiseasesEye Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 23, 2016

First Posted

May 26, 2016

Study Start

December 1, 2014

Primary Completion

January 1, 2016

Study Completion

March 1, 2016

Last Updated

June 8, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)