Eye-ECG Approach to Emergencies : Diagnostic Performance of the HINTS Test

Sponsor
Groupe Hospitalier Paris Saint Joseph (Other)
Overall Status
Completed
CT.gov ID
NCT04118361
Collaborator
(none)
300
1
1
24.2
12.4

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: HINTS Test
  • Diagnostic Test: STANDING Algorithm
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Actual Study Start Date :
Oct 3, 2019
Actual Primary Completion Date :
Jan 24, 2021
Actual Study Completion Date :
Oct 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients with AVS isolated at emergencies

Enrollment of patients with AVS isolated at emergencies

Diagnostic Test: HINTS Test
The HINTS test is a clinical test composed of 3 oculomotor examinations: Search for high-frequency vestibulo-ocular reflex during a passive head impulse test Highlighting of spontaneous nystagmus: it must be sought without, then with Frenzel glasses because they allow to temporarily interrupt the ocular fixation. Vertical divergence This test is performed at the patient's bedside in about 3 minutes. Presence of at least one of the three items of central locator value is sufficient to diagnose a central cause of VAS, including normal early brain imaging.

Diagnostic Test: STANDING Algorithm
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 the practice of release maneuvers.

Outcome Measures

Primary Outcome Measures

  1. 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 [Day 1]

    This outcome measure the sensitivity of the HINTS test performed by a DEM in emergencies for the diagnosis of central and peripheral causes.

  2. 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 [Day 1]

    This outcome measure the specificity of the HINTS test performed by a DEM in emergencies for the diagnosis of central and peripheral causes.

Secondary Outcome Measures

  1. 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 [Day 1]

    This Outcome measure the sensitivity by the STANDING algorithm performed by a DEM in emergencies for the diagnosis of central and peripheral causes. - Performance difference between the HINTS test and the STANDING algorithm

  2. 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 [Day 1]

    This Outcome measure the specificity by the STANDING algorithm performed by a DEM in emergencies for the diagnosis of central and peripheral causes. - Performance difference between the HINTS test and the STANDING algorithm

  3. Opinion of trained doctors on the use and interpretation of the HINTS test and STANDING algorithm [Day 1]

    This outcome is to answer the opinion of trained doctors on the use and interpretation of the HINTS test and the STANDING algorithm

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France France 75014

Sponsors and Collaborators

  • Groupe Hospitalier Paris Saint Joseph

Investigators

  • Principal Investigator: Camille GERLIER, M.D, Groupe Hospitalier Paris Saint Joseph

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier:
NCT04118361
Other Study ID Numbers:
  • Eye-ECG approach
First Posted:
Oct 8, 2019
Last Update Posted:
Jan 14, 2022
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 14, 2022