Clinical trial NCT06515951: Effectiveness of the STANDING Algorithm for the Differential Diagnosis of Vertigo
Official title: Diagnostic Accuracy of the STANDING Algorithm for the Differential Diagnosis of Vertigo in the Emergency Department: a Multicenter Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vertigo
Keywords: Central vertigo
Peripheral vertigo
Ischemic stroke
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
Collaborators: name: Ospedale San Giuseppe di Empoli
name: Ospedale Santo Stefano
name: Azienda USL Toscana Nord Ovest
name: Azienda Ospedaliero-Universitaria Careggi
First posted: 2024-07-23
Enrollment: 456
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Every adult patient presenting in emergency department with vertigo, dizziness or balance disorder.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* patients over 18 years of age.
* patients affected by vertigo, dizziness or balance disorder.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Accuracy of STANDING algorithm for the diagnosis of types of vertigo.
timeFrame: Thirty days
Secondary outcomes:
measure: Change in the use of neuroimaging
timeFrame: Thirty days
measure: Safety of hospital discharge
timeFrame: Thirty days
measure: Accuracy for diagnosis of stroke
timeFrame: Thirty days
measure: Change in the use of specialist consultant
timeFrame: thirty days
Other outcomes:
Locations:
city: Empoli
country: Italy
facility: Azienda USL Toscana Centro, Medicina d'Urgenza e Dipartimento Emergenza e Area Critica
state: Firenze
city: Viareggio
country: Italy
facility: Ospedale Versilia, Medicina d'Urgenza
state: Lucca
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi, Medicina d'Urgenza
state: Tuscany
city: Prato
country: Italy
facility: Nuovo Ospedale di Prato, Medicina d'Urgenza
Study officials:
affiliation: Direttore Dipartimento Emergenza Urgenza e Area Critica AUTC
name: Simone Magazzini, MD
role: STUDY_CHAIR
affiliation: Direttore Dipartimento Diagnostica per immagini AUTC
name: Maurizio Bartolucci, MD
role: STUDY_CHAIR
affiliation: Medicina d'Urgenza Empoli AUTC
name: Paola Bartalucci, MD
role: STUDY_CHAIR
affiliation: Medicina d'Urgenza Empoli AUTC
name: Claudia Casula, MD
role: STUDY_CHAIR
affiliation: Direttore SOC Medicina d'Urgenza EMPOLI; Direttore Area della Formazione Dipartimento Emergenza Urgenza e Area Critica AUTC
name: Simone Vanni, MD
role: PRINCIPAL_INVESTIGATOR
References: