VertigoSTANDINGNCT02782962
Accuracy of a Diagnostic Algorithm for the Differential Diagnosis of Vertigo in the ED: the STANDING.
An observational study of Vertigo and Unsteadiness, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertigo, Unsteadiness
- How many people
- 350 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult patients presenting to the ED of the University Hospital Careggi (AOUC) for vertigo/unsteadiness
Who may be able to join
- Patients with acute vertigo/unsteadiness
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Emergency Department Azienda Ospedaliera Universitaria Careggi
Florence, Tuscany, 50134
About this study
Official title: 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.
Read the 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.
- Assessment of nystagmus presence (spontaneous vs positional) 2) Assessment of nystagmus direction 3) Head Impulse Test (HIT) 4) Standing (SponTaneous, Direction, hIt, standiNG: STANDING)
- 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.
- 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).
- 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).
- 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.
- Conditions
- Vertigo, Unsteadiness
- Keywords
- nystagmus, vertigo, unsteadiness, emergency duplex ultrasonography
- Medical subject headings
- Vertigo, Nystagmus, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Patients with acute vertigo/unsteadiness |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study startDec 2014
- Primary completionJan 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for VertigoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliero-Universitaria Careggi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peiman Nazerian, Azienda Ospedaliero-Universitaria Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02782962
- Sponsor's protocol ID
- 14166
- Acronym
- STANDING
- Status last verified
- Jun 2016
- First submitted
- 23 May 2016
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 25756710Vanni 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.
PubMed 25762835Newman-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.
PubMed 24127701Kerber 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.
PubMed 16946161Bisdorff 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.
PubMed 19893191Karatas M. Central vertigo and dizziness: epidemiology, differential diagnosis, and common causes. Neurologist. 2008 Nov;14(6):355-64. doi: 10.1097/NRL.0b013e31817533a3.
PubMed 19008741Tarnutzer 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.
PubMed 21576300
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of a Diagnostic Algorithm for the Differential Diagnosis of Vertigo in the Emergency Department: the STANDING.
- ClinicalTrials.gov ID
- NCT02782962
- Acronym / sponsor ID
- STANDING / 14166
- Conditions
- Vertigo, Unsteadiness
- Keywords
- nystagmus, vertigo, unsteadiness, emergency duplex ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Azienda Ospedaliero-Universitaria CareggiUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
- Assessment of nystagmus presence (spontaneous vs positional) 2) Assessment of nystagmus direction 3) Head Impulse Test (HIT) 4) Standing (SponTaneous, Direction, hIt, standiNG: STANDING)
- 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.
- 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).
- 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).
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | –Patients with acute vertigo/unsteadiness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients presenting to the ED of the University Hospital Careggi (AOUC) for vertigo/unsteadiness
Key inclusion criteria (1 listed)
- Patients with acute vertigo/unsteadiness
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
- Background: PubMed 25756710Vanni 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.
- Background: PubMed 25762835Vanni 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.
- Background: PubMed 24127701Newman-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.
- Background: PubMed 16946161Kerber 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.
- Background: PubMed 19893191Bisdorff 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.
- Background: PubMed 19008741Karatas M. Central vertigo and dizziness: epidemiology, differential diagnosis, and common causes. Neurologist. 2008 Nov;14(6):355-64. doi: 10.1097/NRL.0b013e31817533a3.
- Background: PubMed 21576300Tarnutzer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertigo and Unsteadiness, run by Azienda Ospedaliero-Universitaria Careggi at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
acute brain injury (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02782962, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2016.