Nystagmus Assessment for Patients Consulting in the Emergency Department for Acute Vertigo

Sponsor

CHU de Quebec-Universite Laval (Other)

Overall Status

Recruiting

CT.gov ID

NCT05176015

Collaborator

(none)

120

Enrollment

Location

Arms

22.5

Anticipated Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This pilot study is perfomed to validate and document faisability of the use of Frenzel lens and the use of a diagnostic algorithm for the assessment of a special sign (nystagmus) observe in the eyes of patients consulting in the emergency department for an acute episode of vertigo/dizziness/imbalance.

Condition or Disease	Intervention/Treatment	Phase
Nystagmus, Acquired Stroke, Acute	Device: Frenzel Lens Diagnostic Test: Diagnostic Algorithm	N/A

Detailed Description

This pilot study is a randomized controlled trial 2 by 2 design to allocated randomly the Frenzel lens and the diagnostic algorithm. There is no use of sham lens. The usual care opposed to the diagnostic algorithm will be questionned only on the perception of nystagmus by the clinician and the use of repositionning particules technique. The only blindings will be the patients about the use of the algorithm and the outcomes assessor about the use or not of Frenzel lens and the use or not of the diagnostic algorithm.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Randomized Controlled Trial on Nystagmus Assessment for Patients Consulting for Acute Vertigo in the Emergency Department With/Without Frenzel Lens With/Without Form: A Pilot Study

Actual Study Start Date :

Jan 15, 2022

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Nov 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Frenzel Lens with Diagnostic Algorithm Frenzel lens will be applied on patients' eyes during different diagnostic manoeuvre to assess if a nystagmus is present and if present describe its main characteristic. Without mentionning to patient, the emergency physician will use a diagnostic algorithm inspired from the TiTrATE approach to interpret the nystagmus and propose the need or the irrelevance for neuro-imaging	Device: Frenzel Lens pair of magnifying glasses (+20 dioptres) that are worn by the patient and an illuminating system. On using Frenzel goggles, the nystagmus is better seen as a result of eyes being magnified and inhibition of visual fixation. Diagnostic Test: Diagnostic Algorithm A diagnostic algorithm using the Tittrate approach: continuous, Intermittant, trigger or spontaneous. The diagnostic algorithm use the REDCap software that include different videos to illustrate diagnostic tests and nystagmus types. Different manoeuvres: HINTS+ battery, Dix-Hallpike test, Supine Head Roll test. Different Particule Repositionning Techniques will be proposed according to specific tests: Epley and Gufoni maneuvres. Risk Scrore is used to assess stroke risk for transient ischemic attack: ABCD2 and the Canandian TIA Risk Score
Experimental: Frenzel Lens without Diagnostic Algorithm Frenzel lens will be applied on patients' eyes during different diagnostic manoeuvres to assess if a nystagmus is present and describe its main characteristics. No diagnostic algorithm will be used to interpret nystagmus.	Device: Frenzel Lens pair of magnifying glasses (+20 dioptres) that are worn by the patient and an illuminating system. On using Frenzel goggles, the nystagmus is better seen as a result of eyes being magnified and inhibition of visual fixation.
Experimental: No Frenzel Lens with Diagnostic Algorithm Nystagmus assessment in different manoeuvres is performed without the use of Frenzel lens. Without mentionning to patient, the emergency physician will use a diagnostic algorithm inspired from the TiTrATE approach to interpret the nystagmus and propose the need or the irrelevance for neuro-imaging	Diagnostic Test: Diagnostic Algorithm A diagnostic algorithm using the Tittrate approach: continuous, Intermittant, trigger or spontaneous. The diagnostic algorithm use the REDCap software that include different videos to illustrate diagnostic tests and nystagmus types. Different manoeuvres: HINTS+ battery, Dix-Hallpike test, Supine Head Roll test. Different Particule Repositionning Techniques will be proposed according to specific tests: Epley and Gufoni maneuvres. Risk Scrore is used to assess stroke risk for transient ischemic attack: ABCD2 and the Canandian TIA Risk Score
No Intervention: No Frenzel Lens and No Diagnostic Algorithm The emergency physician is performing the assessment of nystagmus and its interpretation as usual. The Frenzel lens and the diagnostic algorithm are not used.

Outcome Measures

Primary Outcome Measures

Rate of Nystagmus detection per participant [Day 0]
During eye examination, nystagmus will be characterized according to prominent direction of the fast phase (patients' left, patients' right, up, down, rotational),with their clinical setting or trigger. Overall rate of nystagmus detection by participant. (Rate of typical nystagmus for bening paroxismal peripheral vertigo in the Dix-Hallpike maneuvre or Supine Head Roll Test. Rate of nystagmus detection in the initial physical exam)

Secondary Outcome Measures

Emergency Department Lenght of stay [Day 0, from triage time to Emergency Department departure (admission or home discharge)]
Time spent at the emergency department from triage to time of departure for hospital admission or for home discharge assessed up to 48 hours
Rate of neuro-imaging per participant [From day 0 to 12 weeks]
Any imaging to investigate acute intra-cerebral lesion and/or the neck/brain vascular. anomaly : computed tomography imaging; computed tomography angiogram; magnetic resonance angiography; magnetic resonance imaging, vascular neck ultrasound imaging.
Rate of acute stroke per participant [From day 0 to 12 weeks]
Any acute stroke, hemorrhagic or ischemic, diagnosed by neuro-imaging: computed tomography or magnetic resonnance imaging
Rate of symptomatic central lesion per participant [From day 0 to 12 weeks]
Any central lesion diagnosed by computed tomography or magnetic resonnance imaging that may be related to the initial presentation of vertigo/dizziness/imbalance
Rate of specialised consultations for vertigo/dizziness/imbalance per participant [From day 0 to 12 weeks]
Any specialised consultations (neurology, ENT, cardiology or similar) to investigate the acute vertigo/dizziness/imbalance with the final diagnosis. Summarisation of final diagnosis.
Rate of acute vertigo/dizziness/imbalance related hospitalisation per participant [From day 0 to 12 weeks]
Admission to hospital directly related to vertigo/dizziness/imbalance may be immediate to initial visit or delayed.
Rate of subsequent Emergency Department Visit for Vertigo/dizziness/imbalance per participant [From day 0 t0 12 weeks]
Return visit to the emergency department for vertigo/dizzness/imbalance as chief complaint.
Rate of New Atrial Fibrillation [From day 0 to 12 weeks]
Atrial fibrillation detected by the initial visit electrocadiogram or by long-term cardiac rhythm monitoring (Holter or loop recorder).
Rate of New Stroke at 12 weeks [At 12 weeks]
A stroke free status will be assessed by a validated questionnaire by telephone at tree months and all specialised consultations and neuroimaging will be reviewed for acute stroke diagnosis,
Rate of the use of Particules Repositionning Technique [Day 0]
Once Peripheral Paroxystic Vertigo diagnosis is being diagnosed with the Dix-Hallpike test or with the Supine Head Roll test, the use of particules repositionning technique, Epley or Gufoni maneuvres, will be noted with their immediate impact on acute vertigo.
Rate of Emergency Department Visit Return for Benign Peripheral Paroxystic Vertigo according to Typical Nystagmus [From day 0 to 12 weeks]
Rate of Emergency Department Visit Return for Benign Peripheral Paroxystic Vertigo according to Typical Nystagmus: direction, duration
Initial managment self appreciation of patient presenting in the ED for an acute episode of vertigo/dizziness/imbalance [Day 0]
Simple question answered on a likert scale at the end of the ED encounter. 0% worst, 100% best appreciation.
Adverse Events [From day 0 to 12 weeks]
Combination of stroke, death, neurosurgery, intervenional neuroradiology, thrombolytic therapy