Effectiveness of the STANDING Algorithm for the Differential Diagnosis of Vertigo

NCT ID: NCT06515951

Last Updated: 2024-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

456 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-09

Study Completion Date

2023-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Vertigo

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

STANDING algorithm

Intervention Type 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.

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

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

STANDING algorithm

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ospedale San Giuseppe di Empoli

OTHER

Sponsor Role collaborator

Ospedale Santo Stefano

OTHER

Sponsor Role collaborator

Azienda USL Toscana Nord Ovest

OTHER

Sponsor Role collaborator

Azienda Ospedaliero-Universitaria Careggi

OTHER

Sponsor Role collaborator

Peiman Nazerian

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Peiman Nazerian

Medical Doctor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Simone Magazzini, MD

Role: STUDY_CHAIR

Direttore Dipartimento Emergenza Urgenza e Area Critica AUTC

Maurizio Bartolucci, MD

Role: STUDY_CHAIR

Direttore Dipartimento Diagnostica per immagini AUTC

Paola Bartalucci, MD

Role: STUDY_CHAIR

Medicina d'Urgenza Empoli AUTC

Claudia Casula, MD

Role: STUDY_CHAIR

Medicina d'Urgenza Empoli AUTC

Simone Vanni, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Empoli, Firenze, Italy

Site Status

Ospedale Versilia, Medicina d'Urgenza

Viareggio, Lucca, Italy

Site Status

Azienda Ospedaliera Universitaria Careggi, Medicina d'Urgenza

Florence, Tuscany, Italy

Site Status

Nuovo Ospedale di Prato, Medicina d'Urgenza

Prato, , Italy

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Italy

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

11085

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Stroke Alarm Efficacy Trial
NCT06315192 RECRUITING NA
Head Position in Stroke Trial
NCT01706094 COMPLETED NA