Skip to main content
OpenTrials
Completed

NCT Number: NCT06515951

Effectiveness of the STANDING Algorithm for the Differential Diagnosis of Vertigo

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in the use of neuroimaging

    Time frame: Thirty days

    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.

  2. Safety of hospital discharge

    Time frame: Thirty days

    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.

  3. Accuracy for diagnosis of stroke

    Time frame: Thirty days

    Accuracy (proportion of true positive and negative cases of stroke among the total number of cases examined)

  4. Change in the use of specialist consultant

    Time frame: thirty days

    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.

Sponsors and collaborators

Lead sponsor

Peiman Nazerian

Other

Collaborators

  • Azienda Ospedaliero-Universitaria Careggi
  • Azienda USL Toscana Nord Ovest
  • Ospedale San Giuseppe di Empoli
  • Ospedale Santo Stefano

Registry information

Official study title

Diagnostic Accuracy of the STANDING Algorithm for the Differential Diagnosis of Vertigo in the Emergency Department: a Multicenter Study.

Acronym: STANDING-M

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 23, 2024
Registry last updated
Jul 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.