NCT04919187

Brief Summary

Dizziness, loss of balance, and unsteadiness of gait are common symptoms reported by Emergency Department (ED) patients. The incidence of acute vestibular syndrome (AVS) is increasing and reaches 2-4% of ED visits. In the ED of the Paris Saint Joseph Hospital Group, its incidence was 5% during the year 2019 and 2% during the year 2020 (COVID-19 pandemic period). Emergency medicine is based on a dichotomous principle for any acute pathology in the initial phase. For AVS, the diagnostic dilemma for emergency physicians is usually to differentiate a benign vestibular cause from a potentially serious cerebral cause such as ischemic stroke of the vertebro-basilar territory. The majority of AVS are related to acute vestibulopathies, yet it is necessary to recognize and distinguish a benign paroxysmal positional vertigo (BPPV) from a vestibular neuritis, a vestibular migraine, or a labyrinthine hydrops, to exclude with certainty a cerebral involvement. However, posterior fossa strokes mimic 5% of BPPV and 25% of vestibular neuritis. Among these strokes, about 20% are therefore revealed by a VAS without associated localizing neurological sign. In the absence of a clear neurological sign, the emergency physician must therefore decide whether to treat the patient as an outpatient when he or she suspects a AVS of "peripheral" origin (otolaryngology), or as an inpatient when he or she suspects a "central" origin, in particular a stroke.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
321

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

May 7, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 9, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2022

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

1.1 years

First QC Date

April 30, 2021

Last Update Submit

April 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • To determine the diagnostic accuracy of the STANDING algorithm performed by ED medical student to distinguish central from peripheral causes of isolated AVS in the ED.

    Sensitivity and specificity of the STANDING algorithm performed by ED medical student.

    Day 1

Secondary Outcomes (2)

  • To determine the inter-rater reliability of each items of the STANDING algorithm, between an ED medical student and a senior emergency physician for each patient.

    Day 1

  • To evaluate the changing opinions of ED medical students on vestibulo-ocular examination between the beginning and the end of their internship in the ED

    Day 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This is a prospective diagnostic monocentric cohort study. These patients consulted the SU for symptoms integrated in an isolated AVS, i.e.: vertigo, balance disorder, instability on walking, present for at least one hour and less than one week, as defined by the Barany Society. The study will be reported using the STARD Statement criteria.

You may qualify if:

  • Patient whose age is ≥ 18 years
  • French-speaking patient.
  • Patient presenting on admission to the emergency department with an isolated AVS defined by a course of more than one hour and less than one week and the presence of at least one symptom among:
  • vertigo: an illusion of displacement of the subject in relation to surrounding objects or surrounding objects in relation to the subject, a sensation of rotation, displacement of the body in the vertical plane, instability described as pitching or as a "spinning head", sometimes associated with vegetative signs (nausea, vomiting, pallor, sweating, slowing of the heart rate)
  • and/or spontaneous or positional nystagmus,
  • and/or a gait disorder: such as imbalance with lurching, or a shaky gait, or simple instability.
  • A patient may be included several times during the study period provided that they are distinct acute episodes of isolated AVS.

You may not qualify if:

  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Patient under court protection
  • Patient objecting to the use of his/her data for this research
  • Patient with focal neurological signs concomitant with AVS: a language or writing disorder, a speech disorder such as dysarthria, a disorder in the execution of voluntary movements, a sensory, motor or visual deficit, involuntary abnormal movements
  • Patient with a history of oculomotor paralysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

Location

Related Publications (1)

  • Gerlier C, Fels A, Vitaux H, Mousset C, Perugini A, Chatellier G, Ganansia O. Effectiveness and reliability of the four-step STANDING algorithm performed by interns and senior emergency physicians for predicting central causes of vertigo. Acad Emerg Med. 2023 May;30(5):487-500. doi: 10.1111/acem.14659. Epub 2023 Jan 30.

MeSH Terms

Conditions

Emergencies

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Camille GERLIER, MD

    Fondation Hôpital Saint-Joseph

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2021

First Posted

June 9, 2021

Study Start

May 7, 2021

Primary Completion

June 3, 2022

Study Completion

September 21, 2022

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations