Clinical trial NCT04118361: Eye-ECG Approach to Emergencies : Diagnostic Performance of the HINTS Test
Official title: Eye-ECG Approach to Emergencies : Diagnostic Performance of the HINTS Test Performed by Emergency Physicians to Distinguish a Central Cause From a Peripheral Cause of Isolated Acute Vestibular Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Vestibular Syndrome
Emergencies
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Vertigo integrated with acute vestibular syndrome (AVS) is a frequent reason for emergency visits. The French and international literature estimates between 2 to 4% of vertigo prevalence among reasons for coming to emergencies. International classifications define AVS as vertigo or acute dizziness (less than one month) and persistent, gait instability, nausea or vomiting, nystagmus or an intolerance to head movements.

In emergency departments, the clinical approach of vertiginous patients is difficult because the "vertigo" term is sometimes used in by patients, or because they use the terms "uneasiness", "vertigo", or "dizziness" without distinction. These terms sometimes include various sensations of "sleeping head", "blurred vision", "instability", "pitch" etc. A first difficulty is therefore to clarify these terms and organize syndrome expressed by the patient. A rigorous interrogation is therefore essential and can be time-consuming.

Another difficulty is to carry out an exhaustive clinical examination including the assessment of the general condition and hydration, an ENT examination and a neurological examination. However, at the end of these steps, the orientation central or peripheral etiology is not simple. In the last consensus conference of the Barany Society (2014) the classification of VAS into three types was not sufficient to distinguish "benign" vertigo from "risky" dizziness (related to a central cause).

Detailed description: The HINTS test (Head Impulse, Nystagmus, Test of Skew) is a clinical test composed of 3 oculomotor examinations: the search for high frequency vestibulo-ocular reflex during a passive impulse of the head (Head Impulse test), the detection of a spontaneous nystagmus and a vertical divergence. It has been developed to evaluate patients with AVS defined as vertigo or acute and persistent dizziness sometimes accompanied by nausea or vomiting, and/or gait instability, and/or nystagmus, and/or intolerance to head movements. This time saving is important, as a complete neurological examination usually takes between 10 and 15 minutes. The presence of at least one of the three items of central locator value is sufficient to diagnose a central cause of AVS, including normal early brain imaging. Some studies suggest that absence of these three criteria does not require an emergency neuroimaging examination and allows ambulatory management of the patient, in search of a peripheral cause of the ENT sphere.

The STANDING clinical algorithm (SponTAneous, Nystagmus, Direction, head Impulse test, STANDING) was proposed by Vanni in 2015 for diagnosis of the AVS central causes in emergencies in a one-year prospective Italian monocentric study. The STANDING algorithm consists of clinical elements that can be evaluated in about 10 minutes at the patient's bedside: two oculomotor examinations (Head Impulse Test and detection of a nystagmus), detection of ataxia and practice of release maneuvers.

Currently, the patient management with isolated AVS in the emergency room lacks an ideal diagnostic clinical test: efficient, non-invasive, inexpensive and painless.

The investigators would like to know what diagnostic performance of the HINTS test (sensitivity and specificity) is when it is performed by emergency physicians on a population of patients with isolated AVS in emergency room. They can thus either be part of non-urgent outpatient care in the event of suspicion of a peripheral cause of the ENT sphere, or part of rapid and aggressive inpatient neurological care in the event of suspicion of a central cerebral cause.

Eligibility criteria: Inclusion Criteria:

* French-speaking patient.
* Affiliated with social security or, failing that, with another health insurance system.
* Patient capable of giving free, informed and express consent
* Patient with an isolated AVS defined by a progression of more than one hour and less than one month and at least one of the following criteria:
* Vertigo (illusion of the subject moving in relation to surrounding objects or objects) surrounding with respect to the subject, a sensation of rotation, movement of the body in the plane vertical, unstable, described as a pitch or "rotating head"), sometimes associated with vegetative signs (nausea, vomiting, pallor, sweating, slowing of frequency cardiac),
* A nystagmus (spontaneous or positional),
* Ataxia characterized by gait disorders with imbalance type (which can dominate the symptomatology) with sways, a brittle gait or simple instability.

A patient may be included several times during the study period provided that they are acute episodes separate.

Exclusion Criteria:

* Patient with focal neurological signs concomitantly appearing with AVS: disorder of the language or writing, speech impairment, dysarthria, movement performance disorders voluntary, sensory motor deficit, involuntary abnormal movements. The vertiginous patients with ataxia meet the inclusion criteria provided they do not show any other sign neurological focal, in particular, other signs of cerebellar syndrome.
* Patient with a Glasgow score \<15 or blood glucose \< 0.70 g/l, MAP \< 65 mm Hg, acute anemia and \<7g/dl, transient dizziness having disappeared upon arrival in the emergency room, acute alcohol abuse, acute alcohol abuse, and acute drug intoxication, a history of oculomotor paralysis.
* Patient under guardianship or curatorship.
* Patient deprived of liberty.
* Patient under the protection of justice.

Primary outcomes:
measure: Diagnostic sensitivity of the HINTS test performed by pre-trained emergency doctors (DEMs) to distinguish a central cause from a peripheral cause in a patient with isolated VAS in the emergency department
timeFrame: Day 1
measure: Diagnostic specificity of the HINTS test performed by pre-trained emergency doctors (DEMs) to distinguish a central cause from a peripheral cause in a patient with isolated VAS in the emergency department
timeFrame: Day 1
Secondary outcomes:
measure: Diagnostic sensitivity of the STANDING algorithm performed by DEMs to distinguish a cause of a peripheral cause in a patient with isolated AVS in the emergency department; then compare this performance to the HINTS test
timeFrame: Day 1
measure: Diagnostic specificity of the STANDING algorithm performed by DEMs to distinguish a cause of a peripheral cause in a patient with isolated AVS in the emergency department; then compare this performance to the HINTS test
timeFrame: Day 1
measure: Opinion of trained doctors on the use and interpretation of the HINTS test and STANDING algorithm
timeFrame: Day 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Camille GERLIER, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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