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

December 29, 2021 updated by: Groupe Hospitalier Paris Saint Joseph

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe Hospitalier Paris Saint Joseph

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
Day 1
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
Time Frame: 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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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
Day 1
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
Time Frame: 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
Day 1
Opinion of trained doctors on the use and interpretation of the HINTS test and STANDING algorithm
Time Frame: 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
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Groupe Hospitalier Paris Saint Joseph

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2019

Primary Completion (Actual)

January 24, 2021

Study Completion (Actual)

October 10, 2021

Study Registration Dates

First Submitted

September 23, 2019

First Submitted That Met QC Criteria

October 4, 2019

First Posted (Actual)

October 8, 2019

Study Record Updates

Last Update Posted (Actual)

January 14, 2022

Last Update Submitted That Met QC Criteria

December 29, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Eye-ECG approach

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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