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Acute Vestibular SyndromeEYE LEARNINGNCT04919187

Accuracy and rEliabilitY of the vEstibuLo-ocular ExAmination Performed by inteRNs IN the emerGency Department

An observational study of Acute Vestibular Syndrome and Emergencies, run by Fondation Hôpital Saint-Joseph at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Vestibular Syndrome, Emergencies
How many people
321 participants
Where
1 siteFrance
Study dates
7 May 2021to 21 Sep 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site
  • Groupe Hospitalier Paris Saint Joseph

    Paris, Île-de-France Region, 75014

Other trials in France

About this study

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.

Read the detailed description

Unfortunately, the diagnostic evaluation of an isolated AVS is often frustrating because patients with vertigo tend to be uncertain and imprecise when describing their symptoms. Examination of the vestibulo-ocular pathway, by assessing eye movements in different head positions, is an essential step in the clinical examination to reliably and quickly predict the origin of a AVS. The 3-step clinical rule "HINTS" (Head Impulse, Nystagmus, Test of Skew) was developed in 2009 by "neuro-ophthalmologists" in the USA. It evaluates the vestibulo-ocular reflex by the Head Impulse Test (pathological with the presence of ocular saccades for a peripheral AVS), the characteristics of the nystagmus (multidirectional and/or vertical for a central AVS), and looks for ocular misalignment (Test of Skew with cover-test, pathognomonic of a central involvement). In patients at high cardiovascular risk, HINTS is 100% sensitive and 96% specific in predicting posterior fossa stroke within 2 minutes at the bedside, compared with the Gold-Standard. The "STANDING" (SponTAneous, Nystagmus, Direction, head Impulse test, STANDING) clinical rule is a structured bedside diagnostic algorithm in four clinical steps. It is based on the evaluation of two eye movements (Head Impulse Test and nystagmus), an evaluation of gait (search for ataxia) and the search for positional nystagmus (Dix Hallpike test for the posterior canal and Panigni test or "supine and roll test" for the lateral canal). In the ED, with patients at heterogeneous cardiovascular risk, the STANDING is more interesting than the HINTS. Indeed, it allows the detection of BPPV in pauci-symptomatic patients at the time of their clinical evaluation (i.e., those without spontaneous nystagmus). It had also shown excellent performance (sensitivity:95%, specificity:87-96%) in diagnosing any central cause of VAS in the hands of emergency physicians. However, the 2017 validation study of STANDING had an audit bias. The gold standard test, brain imaging, had only been performed when deemed appropriate (ie, in 34% of peripheral diagnoses, and for only 5% of these by brain MRI).

In the EYE-ECG study conducted at the GhPSJ SU from October 2019 to January 2021, the invesitgators determined the diagnostic performance of these two clinical rules performed by emergency physicians to 300 patients with isolated VAS, comparing it to the Gold-Standard. The manuscript of this study has been published in the Academic Emergency Medicine journal (DOI: 10.1111/acem.14337) in June 2021. Its originality was to evaluate the performance of the tests in the hands of emergency physicians and on a population not selected for its risk of stroke. The investigators showed that the HINTS and STANDING tests had excellent sensitivities (97% and 94% respectively) and negative predictive values (99% and 98% respectively) for predicting any central cause of VAS on brain MRI. They thus allowed emergency physicians to exclude a central cause in a rapid manner (on average 5±3 minutes) with very acceptable false-negative rates (3% and 6%, respectively), and with a potential impact on the reduction of unnecessary brain imaging (-33% and -32%, respectively). For predicting MRI normality, STANDING was more specific than HINTS (75% vs. 67%). This is explained by the addition of a clinical item dedicated to positional nystagmus in the STANDING, and by the high prevalence of BPPV among VAS of ENT origin in SU patients (40%). Indeed, among the false-positives of the HINTS test (erroneously predicted as a central cause for benign vestibular disease), one third of the diagnoses were BPPVs.

The major limitation of the EYE-ECG study was that it did not assess interindividual variability of the HINTS and STANDING tests between different emergency physicians. The STANDING validation study was the only study that assessed global and individual agreement of the algorithm item scores in a binary "central or peripheral" mode between two senior emergency physicians. The inter-observer agreement of the STANDING was good globally (K=0.83) and also at each step of the algorithm (distinction between spontaneous and positional nystagmus: K=0.83, interpretation of a multidirectional or vertical nystagmus: K=0.95, normal Head Impulse Test: K=0.74, recognition of a walking ataxia: K=0.81)18.

Each semester, an average of 7 medical students in general medicine and one in emergency medicine complete an internship at the GhPSJ. In routine practice, the medical students interview and examine their patients alone. They document their clinical examination in the patient's medical record and then present the patient's clinical record to a senior emergency physician. In a second step, the patient is clinically reassessed by the senior emergency physician who becomes responsible for the patient's diagnostic and therapeutic strategy. The accuracy of the vestibulo-ocular examination performed by medical students has never been described in the literature.

The hypothesis of the investigators is that after standardized theoretical training and with the clinical experience gained during their semester in the ED, medical students should be able to examine and interpret the vestibulo-ocular examination of patients with isolated AVS as accurately as seniors.

Medical subject headings
Emergencies

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 1

Secondary outcomes (2)
  1. 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.

    Inter-observer agreement measured by the overall Fleiss Kappa coefficient (K) and by the K each item of the STANDING algorithm performed by the ED medical student and by the senior emergency physician

    Measured: Day 1

  2. 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

    Changing confidences of the ED medical students regarding each item of the STANDING algorithm measured on a survey with a 5-points Likert scale, at the beginning and at the end of their ED internship

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2021
  2. Study start7 May 2021
  3. Primary completion3 Jun 2022
  4. Study completion21 Sep 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04919187
Sponsor's protocol ID
EYE LEARNING
Acronym
EYE LEARNING
Status last verified
Apr 2023
First submitted
30 Apr 2021
Last updated
27 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 36628557

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Vestibular Syndrome and Emergencies, run by Fondation Hôpital Saint-Joseph at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04919187, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.

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