Effectiveness of the STANDING Algorithm for the Differential Diagnosis of Vertigo

NCT06515951 | Completed

• 1 other identifier: 11085
• Study Type: observational
• Target: 456
• Locations: 1 country
• Sites: 4

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.

Conditions

Vertigo

Keywords

Central vertigo; Peripheral vertigo; Ischemic stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  Thirty days

Secondary Outcomes (4)

• Change in the use of neuroimaging

  Thirty days

• Safety of hospital discharge

  Thirty days

• Accuracy for diagnosis of stroke

  Thirty days

• Change in the use of specialist consultant

  thirty days

Study Arms (2)

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

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

Interventions

STANDING algorithm DIAGNOSTIC_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.

STANDING group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Every adult patient presenting in emergency department with vertigo, dizziness or balance disorder.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peiman Nazerian: lead
• Ospedale San Giuseppe di Empoli: collaborator
• Ospedale Santo Stefano: collaborator
• Azienda USL Toscana Nord Ovest: collaborator
• Azienda Ospedaliero-Universitaria Careggi: collaborator

Study Sites (4)

Azienda USL Toscana Centro, Medicina d'Urgenza e Dipartimento Emergenza e Area Critica

Empoli, Firenze, 50053, Italy

Location

Ospedale Versilia, Medicina d'Urgenza

Viareggio, Lucca, 55049, Italy

Location

Azienda Ospedaliera Universitaria Careggi, Medicina d'Urgenza

Florence, Tuscany, 50134, Italy

Location

Nuovo Ospedale di Prato, Medicina d'Urgenza

Prato, 59100, Italy

Location

Related Links

• Validation STANDING study, monocentric
• Derivation STANDING study, monocentric

MeSH Terms

Conditions

Vertigo; Ischemic Stroke

Condition Hierarchy (Ancestors)

Vestibular Diseases; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Simone Magazzini, MD

  Direttore Dipartimento Emergenza Urgenza e Area Critica AUTC

  STUDY CHAIR

• Maurizio Bartolucci, MD

  Direttore Dipartimento Diagnostica per immagini AUTC

  STUDY CHAIR

• Paola Bartalucci, MD

  Medicina d'Urgenza Empoli AUTC

  STUDY CHAIR

• Claudia Casula, MD

  Medicina d'Urgenza Empoli AUTC

  STUDY CHAIR

• Simone Vanni, MD

  Direttore SOC Medicina d'Urgenza EMPOLI; Direttore Area della Formazione Dipartimento Emergenza Urgenza e Area Critica AUTC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: May 10, 2023
• First Posted: July 23, 2024
• Study Start: June 9, 2022
• Primary Completion: June 9, 2023
• Study Completion: November 1, 2023
• Last Updated: July 23, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (4)