Effectiveness of the STANDING Algorithm for the Differential Diagnosis of Vertigo (STANDING-M)

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.

Study Overview

• Status: Completed
• Conditions: Vertigo
• Intervention / Treatment: Diagnostic test: STANDING algorithm

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 Type: Observational
• Enrollment (Actual): 456

Contacts and Locations

Study Locations

• Italy
  • Prato, Italy, 59100
    • Nuovo Ospedale di Prato, Medicina d'Urgenza
  • Firenze
    • Empoli, Firenze, Italy, 50053
      • Azienda USL Toscana Centro, Medicina d'Urgenza e Dipartimento Emergenza e Area Critica
  • Lucca
    • Viareggio, Lucca, Italy, 55049
      • Ospedale Versilia, Medicina d'Urgenza
  • Tuscany
    • Firenze, Tuscany, Italy, 50134
      • Azienda Ospedaliera Universitaria Careggi, Medicina d'Urgenza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Thirty days
Accuracy for diagnosis of stroke	Accuracy (proportion of true positive and negative cases of stroke among the total number of cases examined)	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.	thirty days

Collaborators and Investigators

• Sponsor: Peiman Nazerian
• Collaborators: Azienda USL Toscana Nord Ovest; Azienda Ospedaliero-Universitaria Careggi; Ospedale San Giuseppe di Empoli; Ospedale Santo Stefano
• Investigators: Study Chair: 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; Principal Investigator: Simone Vanni, MD, Direttore SOC Medicina d'Urgenza EMPOLI; Direttore Area della Formazione Dipartimento Emergenza Urgenza e Area Critica AUTC

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2022
• Primary Completion (Actual): June 9, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: May 10, 2023
• First Submitted That Met QC Criteria: July 20, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): July 23, 2024
• Last Update Submitted That Met QC Criteria: July 20, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Ischemic stroke; Central vertigo; Peripheral vertigo
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases; Sensation Disorders; Vertigo; Dizziness
• Other Study ID Numbers: 11085 (DAIDS ES Registry Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No