VertigoSTANDING-MNCT06515951
Effectiveness of the STANDING Algorithm for the Differential Diagnosis of Vertigo
An observational study of Vertigo, run by Peiman Nazerian at 4 sites in Italy.
Trial summary
Differential diagnosis of vertigo is complex especially in emergency department, nevertheless it is crucial. The aim of this study is to assess the accuracy of STANDING algorithm for discriminate central from peripheral type of vertigo, identifying more easily the presence of ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertigo
- What is being tested?
- STANDING algorithm
- How many people
- 456 participants
- Where
- 4 sitesItaly
- Study dates
- 9 Jun 2022to 1 Nov 2023
- 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: Every adult patient presenting in emergency department with vertigo, dizziness or balance disorder.
Who may be able to join
- patients over 18 years of age.
- patients affected by vertigo, dizziness or balance disorder.
Who cannot join
- age under 18.
- patients unable to cooperate (with severe dementia or incapable to provide consensus).
- patients affected by disease of cervical spine or any trauma of this part of body that contraindicate the manipulation of neck.
- impractical follow-up.
- dying patient (less three estimated months to live).
- patients with neurologic deficit identified during triage examination (Cincinnati Prehospital stroke scale, CPSS>0) of suffering from another disease that can be the cause of dizziness/balance disorder (e.g. anemia, arrhythmia, hypoglycemia, alcoholic intoxication).
- patients without symptoms at the time of examination.
- patients who deny the participation in the study.
Trial locations and contacts
4 sites in 1 country.
Italy4 sites
Azienda USL Toscana Centro, Medicina d'Urgenza e Dipartimento Emergenza e Area Critica
Empoli, Firenze, 50053
Azienda Ospedaliera Universitaria Careggi, Medicina d'Urgenza
Florence, Tuscany, 50134
Nuovo Ospedale di Prato, Medicina d'Urgenza
Prato, 59100
Ospedale Versilia, Medicina d'Urgenza
Viareggio, Lucca, 55049
About this study
Official title: Diagnostic Accuracy of the STANDING Algorithm for the Differential Diagnosis of Vertigo in the Emergency Department: a Multicenter Study.
Differential diagnosis of vertigo is complex especially in emergency department, nevertheless it is crucial. The aim of this study is to assess the accuracy of STANDING algorithm for discriminate central from peripheral type of vertigo, identifying more easily the presence of ischemic stroke.
Read the detailed description
Vertigo represents a common medical problem which afflicts about 20-30% of the population and it is a frequent cause of abstention from work and disability. In most cases it is provoked by a benign disease of inner ear, however it can be the main symptom of a more dangerous illness like ischemic or hemorragic stroke, cerebral neoplasm or demyelinating disease. Indeed, vertigo is the prevailing clinical problem in patients with misdiagnosed ischemic stroke, leading to an increase of mortality in the acute phase of disease. In the current state, two diagnostic algorithm have been proposed for the evaluation of acute vertigo, named with the acronyms HINTS and STANDING. The former is characterized by high sensibility and specificity when utilized by a specialist physician, but it is cumbersome to used in emergency department. Conversely, the latter has been validated exactly in this setting and comprises the evaluation of benign paroxysmal positional vertigo and of upright position. The aim of this study is to estimate the accuracy of STANDING algorithm in differentiating peripheral vertigo from central from, in particular ischemic stroke, and its potential usefulness in decreasing the use of neuroimaging and specialist consultant.
- Conditions
- Vertigo
- Being tested
- STANDING algorithm
- Keywords
- Central vertigo, Peripheral vertigo, Ischemic stroke
- Medical subject headings
- Vertigo, Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STANDING algorithmDiagnostic test
The STANDING algorithm is composed by four steps. The first phase consists in evaluating the presence of spontaneous nystagmus at rest for at least five minutes with and without Frenzel goggles in order to assess if a acute vestibular syndrome is present. If there is not a spontaneous nystagmus, then positional maneuvers (Pagnini-Mc Cure and Dix-Hallpike) have to be performed. Otherwise if spontaneous nystagmus is observed, its feature are fundamental to diagnose a central vertigo. If nystagmus characteristics suggest a peripheral form, the head impulse test is performed by instructing the patient to keep eyes on a fixed target and then turned the head quickly. An abnormal response is typical of vestibular neuritis. In any cases after the described maneuvers, the patient must be evaluated when standing up and walking: if this turn out to be impossibile, the test is indicative of central nervous system disease.
| Study group | Role | What they receive |
|---|---|---|
| STANDING group | Consecutive adult patients who access the emergency room due to vertigo / imbalance will be considered eligible for the study. in this group patients will be evaluated by STANDING protocol Receives: Diagnostic Test: STANDING algorithm | |
| Control group | Consecutive adult patients who access the emergency room due to vertigo / imbalance will be considered eligible for the study. in this group patients will be evaluated by standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of STANDING algorithm for the diagnosis of types of vertigo.
Accuracy (proportion of true positive and negative cases among the total number of cases examined) together with sensitivity, specificity, negative and positive predictive values, negative and positive likelihood ratios of STANDING algorithm performed by emergency physicians to distinguish central and peripheral vertigo.
Measured: Thirty days
Secondary outcomes (4)
Change in the use of neuroimaging
Evaluation if the use of STANDING algorithm can reduce the number neuroimaging (a composite of CT of the head and brain MRI) exams performed in patients with suspected central vertigo according to the STANDING algorithm.
Measured: Thirty days
Safety of hospital discharge
Evaluation if the use of STANDING algorithm allows a safe discharge of patients with diagnosis of benign vertigo. At 1 month follow-up we evaluate the composite of: number of readmissions for stroke, need for cerebral revasculation procedures, for neurosurgery or all cause death or death for stroke) in patients without suspected central vertigo according to the STANDING algorithm.
Measured: Thirty days
Accuracy for diagnosis of stroke
Accuracy (proportion of true positive and negative cases of stroke among the total number of cases examined)
Measured: Thirty days
Change in the use of specialist consultant
Evaluation if the use of STANDING algorithm can reduce the number of specialist medical consultations (composite of neurological and ENT consultations) performed in patients with suspected central vertigo according to the STANDING algorithm.
Measured: thirty days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start9 Jun 2022
- Primary completion9 Jun 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Retrospective
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peiman Nazerian
- Sponsor type
- University, hospital or other
- Collaborators
- Ospedale San Giuseppe di Empoli, Ospedale Santo Stefano, Azienda USL Toscana Nord Ovest, Azienda Ospedaliero-Universitaria Careggi
- Responsible party
- Sponsor-investigator, Peiman Nazerian, Azienda Ospedaliero-Universitaria Careggi
- Investigators
- Simone Magazzini, MD, Study chair, Direttore Dipartimento Emergenza Urgenza e Area Critica AUTCMaurizio Bartolucci, MD, Study chair, Direttore Dipartimento Diagnostica per immagini AUTCPaola Bartalucci, MD, Study chair, Medicina d'Urgenza Empoli AUTCClaudia Casula, MD, Study chair, Medicina d'Urgenza Empoli AUTCSimone Vanni, MD, Principal investigator, Direttore SOC Medicina d'Urgenza EMPOLI; Direttore Area della Formazione Dipartimento Emergenza Urgenza e Area Critica AUTC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515951
- Sponsor's protocol ID
- 11085
- Acronym
- STANDING-M
- Status last verified
- Jul 2024
- First submitted
- 10 May 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of the STANDING Algorithm for the Differential Diagnosis of Vertigo in the Emergency Department: a Multicenter Study.
- ClinicalTrials.gov ID
- NCT06515951
- Acronym / sponsor ID
- STANDING-M / 11085
- Conditions
- Vertigo
- Keywords
- Central vertigo, Peripheral vertigo, Ischemic stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Peiman NazerianUniversity, hospital or other
- Collaborators
- Ospedale San Giuseppe di Empoli, Ospedale Santo Stefano, Azienda USL Toscana Nord Ovest, Azienda Ospedaliero-Universitaria Careggi
- Study start
- 9 Jun 2022 (actual)
- Primary completion
- 9 Jun 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 23 Jul 2024 (actual)
- 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.
Differential diagnosis of vertigo is complex especially in emergency department, nevertheless it is crucial. The aim of this study is to assess the accuracy of STANDING algorithm for discriminate central from peripheral type of vertigo, identifying more easily the presence of ischemic stroke.
Detailed description
Vertigo represents a common medical problem which afflicts about 20-30% of the population and it is a frequent cause of abstention from work and disability. In most cases it is provoked by a benign disease of inner ear, however it can be the main symptom of a more dangerous illness like ischemic or hemorragic stroke, cerebral neoplasm or demyelinating disease. Indeed, vertigo is the prevailing clinical problem in patients with misdiagnosed ischemic stroke, leading to an increase of mortality in the acute phase of disease. In the current state, two diagnostic algorithm have been proposed for the evaluation of acute vertigo, named with the acronyms HINTS and STANDING. The former is characterized by high sensibility and specificity when utilized by a specialist physician, but it is cumbersome to used in emergency department. Conversely, the latter has been validated exactly in this setting and comprises the evaluation of benign paroxysmal positional vertigo and of upright position. The aim of this study is to estimate the accuracy of STANDING algorithm in differentiating peripheral vertigo from central from, in particular ischemic stroke, and its potential usefulness in decreasing the use of neuroimaging and specialist consultant.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STANDING group | – | Diagnostic Test: STANDING algorithmConsecutive adult patients who access the emergency room due to vertigo / imbalance will be considered eligible for the study. in this group patients will be evaluated by STANDING protocol |
| Control group | – | –Consecutive adult patients who access the emergency room due to vertigo / imbalance will be considered eligible for the study. in this group patients will be evaluated by standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every adult patient presenting in emergency department with vertigo, dizziness or balance disorder.
Key inclusion criteria (2 listed)
- patients over 18 years of age.
- patients affected by vertigo, dizziness or balance disorder.
Key exclusion criteria (8 listed)
- age under 18.
- patients unable to cooperate (with severe dementia or incapable to provide consensus).
- patients affected by disease of cervical spine or any trauma of this part of body that contraindicate the manipulation of neck.
- impractical follow-up.
- dying patient (less three estimated months to live).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STANDING algorithmThe STANDING algorithm is composed by four steps. The first phase consists in evaluating the presence of spontaneous nystagmus at rest for at least five minutes with and without Frenzel goggles in order to assess if a acute vestibular syndrome is present. If there is not a spontaneous nystagmus, then positional maneuvers (Pagnini-Mc Cure and Dix-Hallpike) have to be performed. Otherwise if spontaneous nystagmus is observed, its feature are fundamental to diagnose a central vertigo. If nystagmus characteristics suggest a peripheral form, the head impulse test is performed by instructing the patient to keep eyes on a fixed target and then turned the head quickly. An abnormal response is typical of vestibular neuritis. In any cases after the described maneuvers, the patient must be evaluated when standing up and walking: if this turn out to be impossibile, the test is indicative of central nervous system disease. | Diagnostic test | STANDING group |
Primary outcome
Accuracy of STANDING algorithm for the diagnosis of types of vertigo.
Time frame: Thirty days
Accuracy (proportion of true positive and negative cases among the total number of cases examined) together with sensitivity, specificity, negative and positive predictive values, negative and positive likelihood ratios of STANDING algorithm performed by emergency physicians to distinguish central and peripheral vertigo.
4 secondary outcomes
Change in the use of neuroimaging
Time frame: Thirty days
Safety of hospital discharge
Time frame: Thirty days
Accuracy for diagnosis of stroke
Time frame: Thirty days
Change in the use of specialist consultant
Time frame: thirty days
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 23 Jul 2024.
- Validation STANDING study, monocentricLink provided by the sponsor.
- Derivation STANDING study, monocentricLink provided by the sponsor.
- 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.
Simone Magazzini, MD study chair
Direttore Dipartimento Emergenza Urgenza e Area Critica AUTC
Maurizio Bartolucci, MD study chair
Direttore Dipartimento Diagnostica per immagini AUTC
Paola Bartalucci, MD study chair
Medicina d'Urgenza Empoli AUTC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertigo, run by Peiman Nazerian at 4 sites 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 2 inclusion and 8 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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Accuracy of STANDING algorithm for the diagnosis of types of vertigo. (time frame: Thirty days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2024.