Effectiveness of the STANDING Algorithm for the Differential Diagnosis of Vertigo

Completed

• Conditions: Vertigo
• Interventions: Diagnostic Test: STANDING algorithm

• Registration Number: NCT06515951
• Lead Sponsor: Peiman Nazerian

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.

Study Timeline

• Study Start: 2022-06-09
• Study First Submitted: 2023-05-10
• Primary Completion: 2023-06-09
• Study Completion: 2023-11-01
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-20
• Last Update Submitted: 2024-07-20
• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 456

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
STANDING group	STANDING algorithm	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

Primary Outcome Measures

Name	Time	Method
Accuracy of STANDING algorithm for the diagnosis of types of vertigo.	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 Outcome Measures

Name	Time	Method
Change in the use of specialist consultant	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.
Safety of hospital discharge	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.
Change in the use of neuroimaging	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.
Accuracy for diagnosis of stroke	Thirty days	Accuracy (proportion of true positive and negative cases of stroke among the total number of cases examined)

Trial Locations

Locations (4)

Ospedale Versilia, Medicina d'Urgenza; 🇮🇹 Viareggio, Lucca, Italy

Azienda Ospedaliera Universitaria Careggi, Medicina d'Urgenza; 🇮🇹 Firenze, Tuscany, Italy

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

Nuovo Ospedale di Prato, Medicina d'Urgenza; 🇮🇹 Prato, Italy